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VATSAKADI QWATHA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO DIABETES MELLITUS (NIDDM), SRIKRISHNA H.A, Kayachikitsa, A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE KOPPATRANSCRIPT
CLINICAL EVALUATION OF VATSAKADI QWATHA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO
DIABETES MELLITUS (NIDDM)
BY
Dr. SRIKRISHNA H.A BAMS (RGUHS)
Dissertation submitted to the Rajiv Gandhi University of Health sciences, Karnataka, Bangalore
In partial fulfillment Of the requirements for the degree of
Ayurveda Vachaspati” M.D. [Ayurveda]
In KAYACHIKITSA
GUIDE Dr. SURESH R.D
M.D. (Ayu), MS (C&P), CYS.
DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE
KOPPA – 577126, CHIKMAGALUR DISTRICT KARNATAKA, INDIA NOVEMBER - 2010
I hereby declare that this dissertation entitled “Clinical Evaluation Of
Vatsakadi Qwatha In The Management Of Madhumeha W.S.R To Diabetes
Mellitus (NIDDM).” is a bonafide and genuine research work carried out by me
under the guidance of DR.SURESH.R.D. Department of Post Graduate Studies
in KAYACHIKITSA, A.L.N. Rao Memorial Ayurvedic Medical College P. G. Centre,
Koppa
Date:
Place: Koppa
Department of Post graduate Studies in KAYACHIKITSA
A.L.N.Rao Memorial Ayurvedic Medical College Koppa – 577126 Dist: Chikmagalur
Declaration
DR.SRIKRISHNA H.A P.G.SCHOLAR,
Dept. of Kayachikitsa A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126
This is to certify that the dissertation entitled “Clinical Evaluation Of
Vatsakadi Qwatha In The Management Of Madhumeha W.S.R To Diabetes
Mellitus (NIDDM).” is a bonafide research work done by
DR. SRIKRISHNA H.A, in partial fulfillment of the requirement for the
degree of Ayurveda Vachaspati (MD) in KAYACHIKITSA of Rajiv Gandhi
University of Health Sciences, Bangalore, Karnataka.
Date:
Place: Koppa
Department of Post graduate Studies in KAYACHIKITSA
A.L.N.Rao Memorial Ayurvedic Medical College Koppa – 577126 Dist: Chikmagalur
Certificate
DR SURESH R.D M.D (Ayu), MS (C&P), CYS
GUIDE & ASSISTANT PROFESSOR Post graduate Department of Kayachikitsa
A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126
Department of Post graduate Studies in KAYACHIKITSA
A.L.N.Rao Memorial Ayurvedic Medical College Koppa – 577126 Dist: Chikmagalur
This is to certify that the dissertation entitled “Clinical Evaluation Of Vatsakadi
Qwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus
(NIDDM).” is a bonafide research work done by DR. SRIKRISHNA H.A,
in partial fulfillment of the requirement for the degree of Ayurveda Vachaspati (MD)
in KAYACHIKITSA of Rajiv Gandhi University of Health Sciences, Bangalore,
Karnataka.
Date:
Place: Koppa
A.L.N.Rao Memorial Ayurvedic Medical College Koppa – 577126 Dist: Chikmagalur
Department of Post graduate Studies in KAYACHIKITSA
Certificate
DR. DEBAJIT BHATTACHARYA M.D. (Ayurveda)
H.O.D. & PROFESSOR Post Graduate Department of Kayachikitsa
A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126
This is to certify that the dissertation entitled “Clinical Evaluation Of Vatsakadi
Qwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus
(NIDDM).” is a bonafide research work done by DR. SRIKRISHNA.H.A,
in partial fulfillment of the requirement for the degree of Ayurveda Vachaspati (MD)
in KAYACHIKITSA of Rajiv Gandhi University of Health Sciences, Bangalore,
Karnataka.
Date:
Place: Koppa
Prof. DR.SANJAYA.K.S. B Sc, MD (Ayurveda)
PRINCIPAL, A.L.N.Rao Memorial Ayurvedic Medical College,
Koppa –577126
Endorsement
COPYRIGHT
I hereby declare that the Rajiv Gandhi University of Health Sciences,
Karnataka shall have the rights to preserve, use and disseminate this dissertation in
print or electronic format for academic/research purpose.
Date:
Place: Koppa
© Rajiv Gandhi University of Health Sciences, Karnataka
DR.SRIKRISHNA.H.A P.G.Scholar,
Dept. of Kayachikitsa A.L.N. Rao Memorial Ayurvedic
Medical College, Koppa – 577 126
ACKNOWLEDGEMENT
Salutations and surrenderence of this whole work under the lotus feet of his highness and holiness Sri Sri Sri Rangapriya Mahadesikan and his highness and holiness Sri Sri Sri Swayamprakasha Sachidananda Saraswathi Mahaswamiji.
Salutations and surrenderence to the self within beloved parents, Sri.H.S.Ananthashayanam (Retired Manager, ING VYSYA BANK and Smt.M.S.Vedavalli (Retired Headmistress), innate selfmate Mr. Srinidhi H.A and sister-in-law Smt Dr Janaki, Sri Sitaram Bhat and Smt. Nagaratna and all my other family members whose constant blessings through true - love, support, sacrifice, encouragement and inspiration has sculptured this whole work towards its smooth and successful completion.
Salutations and surrenderence to the self within beloved great teachers Dr Rangapriya Mahadesikan, Dr.N. Shivarama Gayathri, Dr. Shobha. G. Hiremath, Dr Geetha Bhai, Dr Ahalya who taught and will be teaching the essential lessons of Ayurveda for lifetime.
Salutations and surrenderence to the self within beloved and respected Guide Dr. Suresh. R. D, M.D (Ayu), MS (C&P), CYS, P.G Dept. of Kayachikitsa, A. L. N. Rao Memorial Ayurvedic Medical College Koppa for his blessings through high esteemed standards of guidance, meticulous supervision, timely advices, motivation, inspiration and co-operation throughout the successful completion of this dissertation work.
Salutations and surrenderence to the self within beloved and respected Sri. Aroor Ramesh Rao, President, A.L.N. Rao Memorial Ayurvedic Medical College, Koppa for giving an opportunity to pursue post-graduate study in his esteemed and prestigious institution.
Salutations and surrenderence to the self within beloved and respected Dr.Sanjaya.K.S M.D (Ayu), Principal, A.L.N Rao Memorial Ayurvedic Medical College, Koppa for his immense help and support in completing this work.
Salutations and surrenderence to the self within beloved and respected Dr. Debajith Bhattacharya M.D (Ayu), HOD and Professor, P.G Department of Kayachikitsa and Prof. Dr P.K. Mishra M.D (Ayu),
Department of Kayachikitsa for their blessings through great hearty inspiration.
Salutations and surrenderence to the self within beloved and respected P.G staffs in the Dept. of Kayachikitsa; Dr.Prasanth G.S M.D
(Ayu),PhD, Dr.C.B.Singh M.D (Ayu), Dr. Rita Singh M.D (Ayu), Dr. Srinivas M.D (Ayu), Dr. Shobha Shetty M.D (Ayu), Dr.Niranjan, M.D (Ayu), Dr.Smitha Manoj M.D
(Ayu), Dr Usha Rani M.D (Ayu) Dr Triveni M.D (Ayu) and Dr. Shobha. R. Itnal M.D (Ayu).
Salutations and surrenderence to the self within beloved and respected Prof. T.K.Mohanta M.D, PhD (Ayu) and Prof. R.R. Mishra, M.D (Ayu), for their substratal constructive suggestions during the successful completion of this Dissertation work.
Salutations and surrenderence to the self within beloved and respected Prof. Dr D.K.Mishra M.D (Ayu), HOD of Bhaishajya Kalpana & Assistant Principal of P.G faculty and Prof. Dr Vidyasagar M.D (Ayu), HOD of Dravyaguna for their constant encouragement and valuable suggestions.
Salutations and surrenderence to the self within beloved and respected Dr. Prashanth Kumar Jha DIM, CIPR, PGDEE, MSc, Ph.D. Head, Quality Control Laboratories, for his guidance and support for Phyto Chemical Analysis without which the study would have been incomplete.
Salutations and surrenderence to the self within beloved and respected Prof. Dr H.R.Pradeep M.D (Ayu) Assistant Principal of U.G faculty and other P.G. faculty of Dravyaguna Department; Dr.Ilanchezhian M.D (Ayu), Dr.Harivenkatesh M.D (Ayu), Dr Vinayak Bhat M.D (Ayu) and Dr.Bhanu M.D (Ayu) for their extensive help in the drug review.
Salutations and surrenderence to the self within beloved and respected Dr.Mathapati M.D (Ayu), Dr. Milind Hukkeri M.D (Ayu), Dr. Roshy M.D (Ayu), Dr. Harikrishnan M.D (Ayu), Dr. Abdul Kareem M.D (Ayu), Dr. Shubha Shastry M.D (Ayu) and Dr. Sandeep Sarode M.D (Ayu), Department of Bhaishajya Kalpana for their guidance in the preparation of medicine.
Salutations and surrenderence to the self within beloved and respected Dr. Suryakumar, M.D (Ayu), Dr Basavaraj M.D (Ayu), Dr Vidyavati M.D (Ayu) from the Department of Shalakya Tantra, Dr. Laxmikanth M.D
(Ayu), Dr. Vikram M.D (Ayu), Dr. Mithun M.D (Ayu) and Dr. Satish M.D (Ayu), from the Department of Shalaya Tantra for their support in the dissertation work.
Salutations and surrenderence to the self within beloved and respected Dr. Suhas Shetty, M.D (Ayu), for his kind inspirational attitude and meticulous guidance in statistical work.
Salutations and surrenderence to the self within beloved and respected Dr. Ram Mohan, and Dr. Shanbhag, Consultant Physicians of this bonafide Ayurvedic college and hospital for their support during various stages of this work.
Salutations and surrenderence to the self within Dr. Sandhya, M.D (Ayu), Dr. Elizabath, M.D (Ayu), Dr. Sonmankar, M.D (Ayu), Dr. Basavaraj, M.D (Ayu), Dr. Moharar M.D (Ayu), Dr. Rashmi Sharma M.D (Ayu), Dr. Saraganachary M.D (Ayu) and Dr. Prashanth.K M.D (Ayu), for their moral support during the study tenure.
Salutations and surrenderence to the self within the treasurest, the sweetest reminiscences of loving and affectionate sharing and caring attitude shown by our dear seniors Dr. Nagendra M.D (Ayu), Dr. Sreejith M.D (Ayu), by dear loving batchmates Dr. Bejoy, Dr. Lovelin eralil, Dr. Krishnaveni, Dr. Thulya, Dr. Sriparvathi, Dr. Deepa, Dr. Ananda Bhairavi, Dr. Pallavi, Dr. Katyayani, Dr. Kiran, Dr. Jagadish Mayya, Dr. Narappa Reddy, Dr Vaishnavi, by dear loving juniors Dr. Suresh, Dr. Sudev, Dr. Subin, Dr. Jayakrishnan, Dr. Neelakantan, Dr. Divya Khare, Dr. Dhanyamurali, Dr. Soumit kumar, Dr. Parag, Dr. Kanchan kulkarani whose warmth hearty and intellectual memories will always be cherished as the ei-force, besides just being the e & i forces for the successful completion of this work.
Salutations and surrenderence to the self within all the patients who were included and excluded during the study for being the primordial ei-force for the present and the future endeavours.
Salutations and surrenderence to the self within all the hospital staff, pharmacy staff and especially for Ms. Amrutha and Mr. Mohana, the Lab technicians for their immense hearty and intellectual support for the successful completion of this work.
Koppa, Nov. 2010. Dr. Srikrishna.H.A
ABSTRACT
Madhumeha is a term considered for the condition of all types of Prameha and
specifically for one among the Vatika Prameha as elucidated by Acharya Chakrapani
in Charaka Samhita and is characterized by Prabhuta and Avila Mutrata as the
Samanya Lakshana. With specific Madhumeha lakshanas, some Ayurvedic scholars
correlate Madhumeha with Diabetes Mellitus, which is a metabolic disorder
characterized by hyperglycemia with or without Glycosuria resulting from an absolute
or conditional deficiency of insulin. Madhumeha which has been correlated with
Diabetes Mellitus has become a global health threat inspite of advances in
conventional science; while, India has been projected by W.H.O as the country with
the fastest growing population of Diabetic patients. Recent studies have estimated that
in the year 2000, 171 million people had diabetes and are expected to double by
20301. So, in an attempt for early diagnosis and to combat this disease condition
effectively; a formulation, Vatsakadi Qwatha mentioned in Sharangadhara Samhitha,
Qwatha Kalpana Adhyaya in the context of Mehagna qwatha, has been selected for
the present study based on the hypothesis that the drugs like Vatsaka, Triphala,
Daruharidra, Musta and Bijaka having Tikta Kashaya as the Pradhana Rasa and
Mehagna property are potent enough to combat this disease condition and are also
easily available.
OBJECTIVES:
• To evaluate the efficacy of the formulation, Vatsakadi Qwatha in the management of
Madhumeha w.s.r to Diabetes Mellitus (NIDDM).
• To assess the merits and demerits of the trial drug, Vatsakadi Qwatha.
• Detailed study of the disease covering classical and modern literatures.
• To evaluate the Diabetic Quality of life.
METHODS:
Cases presenting with classical sign and symptom of Madhumeha were
selected. The preparation Vatsakadi Qwatha had been given to a group of 20 patients.
The symptoms of Madhumeha like Prabhutamutrata, Avilamutrata, Pipasa, Kshudha
etc had been assessed before and after the treatment. The duration of the study was 45
days with 90 days follow up study with assessment of results at the interval of 15
days.
RESULTS:
The drug Vatsakadi Qwatha showed significant results in combating the
symptoms of the disease Madhumeha during treatment period. The follow up results
were insignificant.
CONCLUSION:
The Polyherbal formulation Vatsakadi Qwatha was effective in the
management of Madhumeha during treatment period and was not effective enough
during the follow up period. The ingredients of the formulation are easily available;
needs constant discrete observation over the subject by the treating physician and has
a wide scope for further studies.
KEYWORDS:
Madhumeha, Diabetes Mellitus, Vatsakadi Qwatha.
CONTENTS SL. NO. TOPIC PAGE
1. Chapter- I INTRODUCTION 1
2. Chapter- II OBJECTIVES 4
3. Chapter- III REVIEW OF LITERATURE
a) HISTORICAL REVIEW 5
b) DISEASE REVIEW 11
c) DRUG REVIEW 90
4. Chapter- IV METHODOLOGY
a) MATERIALS & METHODS 99
b) OBSERVATIONS 110
5. Chapter- V RESULTS 128
6. Chapter- VI DISCUSSION 139
7. Chapter- VII CONCLUSION 164
8. Chapter- VIII SUMMARY 166
9. REFERENCE
10. BIBLIOGRAPHY
11. ANNEXURE
ABBREVIATIONS
1. A.Hr Ashtangahrudayam
2. A.Sa Ashtangasangraham
3. Cha.Sam CharakaSamhitha
4. Su.Sam Susrutha Samhita
5. Ma.Ni Madhava Nidanam
6. Sha.Sam Sharangadhara Samhitha
7. Ka.Sam Kashyapa Samhitha
8. Ha.Sam Harita Samhitha
9. Bha.Pra Bhavaprakasam
10. Y.R Yogaratnakaram
11. H.P.I.M Harrisson’s Principles of Internal Medicine
12. D.P.P.M Davidson’s Principles and Practice of Medicine
13. Ni Nidanasthanam
14. Chi Chikitsasthanam
15. In. Indriyasthanam
16. Vi Vimanasthanam
17. U. Utharardham
18. R.V Rig-Veda
19. S.B Shayana Bhashya
20. C.D Chakradutta
21. R.P Robbins-Pathology
22. K.V.K.C.M Clinical Medicine - K.V.Krishnadas
23. Chak Chakrapani
24. Ni.Sam Nibandha Sangraha
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
INTRODUCTION
|| िन या: ूाणभतृां देहे वात प कफा य: । वकृताः ूकृितःथा वा तान बुभु सेत प डतः ॥् - च.सू.१८/४८
In an attempt to dig out the secrets of healing within the asylum of diseases;
the therapeutic pearls of wisdom in the form of aphorisms delivered by our Ancient
Ayurvedic Seers several thousand decades ago is now still on the verge of great
discoveries and achievements, under the sacred healing hands of the present day
Ayurvedic Professionals of varied specialties.
The Prime Eternal Objective Instinct of these professionals being the Quest Of
three fundamental humors in relationship with the elan vital governing both Healthy
and Non-Healthy state of the Human Body, Mind and Soul, thus guiding them to the
greatest heights of professional success by fulfilling the four essential pursuits of life1.
Thus, literally, the word Ayurveda cannot be restricted to be defined as only –
Science of Life but, it would be wise enough to be extended as the Most Scientific
Eternal Divine Coded Medical Language which teaches the value of being healthy
and the means to achieve it through our day to day activities of life.
This is achieved by the Ayurvedic professionals with the help of the four
essential limbs of therapeutics like the Bhishak, Dravya, Upastha and Rogi
respectively, termed as Bhishak Chatushpada by the ancient seers.
‐
The present 21stcentury is gradually and drastically changing the attitude of
every individuals of the society towards every aspect of life by guiding and prompting
them towards a weird quality of day to day physical and mental activities and finally
making them to lead an obsessive, erratic lifestyle which in turn has led to an health
crisis of various lifestyle disorders. One among those lifestyle disorders is
Madhumeha vis a vis Diabetes Mellitus, which is now becoming a major health threat
in both developed and developing countries. Statistically, India is now considered as
1 -
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
the diabetic capital and is sure to double from the 2010 - 171 million diabetics by
2030.
Acharya Charaka has quoted “as the birds are attracted towards the tree
where their nests lies, similarly Madhumeha affects people who are voracious eaters
and have aversion to physical exercise. The disease Madhumeha, its definition,
etiology, clinical features and principles of treatment appear to be similar with the
disease “Diabetes Mellitus”, which is considered as “Ice Berg” disease in the present
era1.
Our classics have termed Madhumeha1 as Asadya keeping in terms of Vataja
Prameha and also as a Kulaja Vikara - Jataja but, the term here in the present study is
taken in accordance to the opinion of Acharya Chakrapani where Meha Samuha can
also be termed as Madhumeha and by the timely intervention with appropriate
Oushadha, Pathya and Vyayama for the same both the short-term and long-term
complications can be effectively managed and prevented by breaking the vicious
cycle of pathology and thereby enhance the Quality Of Life of the patient. If it is not
done so; then, the disease pathology progresses enough to gain a strong chronicity and
becomes Asadya.
Ayurveda proposes number of Herbal and Herbo-mineral formulations for the
management of Madhumeha. Here a sincere attempt has been made to provide a
better management of this dreadly condition, Madhumeha. The present research work
undertaken is entitled as “Clinical Evaluation of Vatsakadi Qwatha in the
Management of Madhumeha With Special Reference to Diabetes Mellitus” based
on the hypothesis that the formulation Vatsakadi Qwatha11 mentioned in
Sharangadhara Samhita, Madhyama khanda, 2nd Chapter- Qwatha Kalpana Adhyaya-
Mehagna context, with its ingredients Vatsaka1, Haritaki, Amalaki, Vibhitaki,
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Daruharidra, Musta and Bijaka have Tikta Kashaya Rasa Pradhanata and
Mehagna property.
The present work also includes theoretical aspects of Madhumeha, brief
historical review, Nirukti and Paribhasha, Nidana Panchaka, Bheda, Sapeksha Nidana,
Chikitsa, Upadrava, Sadhya Asadhyatha as explained by different Ayurvedic classics
and also its modern parlance.
Random selection of patients for clinical study, case study, adopted treatment
and its methods with respective subjective and objective parameters, results
discussion and conclusion are dealt at the end in detail.
Thus the entire work has been strategized chapter wise in the following
manner:
Chapter I Introduction
Chapter II Objectives
Chapter III Review of literature
Chapter IV Methodology
Chapter V Observation
Chapter VI Results
Chapter VII Discussion
Chapter VIII Conclusion
Chapter IX Summary
Bibliography
Annexure
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
OBJECTIVES
The study is based on the following aims and objectives.
1) To assess the efficacy of ‘Vatsakadi Qwatha’ in the management of Madhumeha.
2) To assess the merits and demerits of the drug.
3) Detailed study of the disease covering classical and modern literature.
4) To evaluate the Diabetic Quality Of Life.
HYPOTHESIS
1. Null Hypothesis:
Vatsakadi Qwatha does not have any effect in the management of patients suffering
from Madhumeha.
2. Alternative Hypothesis:
Vatsakadi Qwatha do have effective role in the management of patients suffering
from Madhumeha.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
HISTORICAL GLIMPSES
Study of sequential evolution of an event forms the fremost step in the field of
research. Study of history is of great important to know about the systematic development and
progress of the subject to determine the future plans for further establishment and research
designing. History of Medicine starts from the very moment when the human beings came
into existence. Among the various ancient treatises, Ayurveda provides an extensive and
emeritus description of diseases and their treatment. Here an attempt to review all the
Ayurvedic and Modern Treatises providing information related to historical background of
Madhumeha has been made.
The evolution of Madhumeha can be traced right back from Vedas but, in
rudimentary form. When we go through the Atharvaveda there is a reference related to the
disease 'Asrava' along with its management. Sayana Acharya in his Sayana Bhashya reveals
that Asrava means 'Mutraatisara,' the English translator Whitney (1962) interpreted it as flux
and Griffith (1962) as morbid flow, while leeman has translated the meaning of Asrava as
Diabetes Mellitus. Sayanacharya has highlighted the vatic nature of this ailment.
(A) Samhita Period:
Elaborative description of the disease Meha viz-a-viz Prameha- Madhumeha has been
found during Samhita period.
(1) Charaka Samhita: Ref Cha. Ni. 4, Cha. Chi. 6
In this ancient treatise of medical science, Charaka has explained the Etiology,
Pathogenesis, Prodromal Symptoms, Clinical Features, expected Complications and
descriptive therapeutic procedures with discretion – Sutra Sthana 17th chapter, Nidana Sthana
4th chapter, Chikitsa Stana 6th chapter.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
(2) Sushruta Samhita: Ref. Su. Ni. 6, Su. Ni. 11, 12,13.
Acharya Sushruta has contributed that the disease Prameha which when not treated at
appropriate time gets transformed into Madhumeha in Nidana Sthana – 6th chapter, the whole
disease and its therapeutic purview in Prameha – Pramehapidaka – Madhumeha in Chikitsa
Sthana – 11th, 12th, 13th chapters successively. The distinct feature is the usage of Ksaudra
Meha' instead of Madhu Meha in vatic variety in Nidana Sthana 6th chapter, Specific
decoctions for specific type Prameha and mentioned the Specific Dietary Pattern which
should be avoided and to be used accordingly in Chikitsa Sthana.
(3) Vagbhata Samhita: Ref. A.Hr. ni.10,
A.Hr.12
Vagbhata has mentioned 2-3 types of underlying cause leading to Madhumeha i.e.
Dhatukshaya and Avrutapatha or even both and added Sveda as one among the Dushya in
Nidana Sthana 10th chapter.
(4) Harita Samhita: Ref Ha.Sam. II sthana 1/9
Acharya Harita has mentioned the cause as Papajanya and enumerated 13 types of
Prameha with nomenclature different than above treatise like, Puyameha, Ghrutameha etc.
(5) Bhela Samhita:
He described Prameha is of two type i.e. Svayamkruta and Prakruta Meha.
(6) Kashyapa Samhita:
He has mentioned the symptoms of juvenile diabetes clinical findings in Vedana
Adhyaya and noted the disease as Chirakari.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
(B) MEDIEVAL PERIOD:
In this period commentaries mainly written, but most of them content only the
collection of thoughts from previous authors.
(1) Madhavanidana: Ref. Ma. Ni. 33
He collectively repeated the description of Charaka, Susruta and Vagbhata.
(2) Gayadasa: Ref. Nyaya Chandrika Su. Ni.6/6
He has explained that the Samalatva of the Mutra is due to the presence of Dusya in
Mutra.
(3) Sharangadhara Samhita: Ref. Sha. Ma.11
He has mentioned the 20 types of Prameha in Prathama Khanda 7th chapter, while we
find various scattered references with respect to the disease and the respective formulations
for the latter in different forms. The Polyherbal formulation for the present study has been
selected from Qwatha Kalpana Adhyaya of the present treatise mentioned in Madhyama
Khanda. Meha Prakarana.
(4) Bhavaprakasa: Ref Bha. Ni. Ma. Kha. 38
He describes Prameha and Madhumeha along with some new Herbo-Mineral
preparations.
(5) Yogaratnakar:
He has explained Prameha and Madhumeha along with its respective treatment.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
MODERN REVOLUTION AND THERAPEUTIC LANDMARKS:
Some of emeritus inventive landmark about the Diabetes Mellitus:
(1) Areatus (Christian era) : Firstly he mentioned the disease as Diabetes.
(2) William Cullen - 1709 A.D : Added suffix mellitus to the diabetes.
(3) Mathew Dobson L-1775 A.D : Found that sweetness of urine is due to sugar.
(4) Thomas Cowley -1781 AD : Pancreas as the possible cause of the disease.
(5) Paul Langerhans -1869 AD : Group of cells in Pancreas.
(6) Gusteve Edward -1893 AD : Group of cells as Islets of Langerhans.
(7) Opie -1901 AD : Hypothesis- Islets Of Langerhans dysfunction.
(8) Babting and Charles -1922 AD : Discovered Insulin.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
NIRUKTHI AND PARIBHASHA
In Ayurveda, Madhumeha is a term used for all the 20 types of Prameha and
also as a sub type of Vatika Prameha which is Asadya. In this present study since
Madhumeha is taken in terms of Meha Samuha but not restricted to the terms of
Vatika Prameha hence understanding its literal Derivation is quite important for
proper understanding of the intricacies in the usage of the term Madhumeha1.
ETYMOLOGY:
Meha: The word Meha is derived from the root ‘Mih Sechane’ by adding 'lyu’
Pratyaya to it, gives the meaning watering. - Shabda Kalpadruma.
� Mehayati Sinchati Mutraretamsi iti mehaha� - Halayudha Kosha
� Mehayati mutrayati iti arthaha� - Su. Ni. 9/10
This term is suppose to be used for all types of Meha either it is Prameha or
Madhumeha- according to Acharya Chakrapani.
The first and the foremost Vedic reference for the word Meha is found in the
Yakshma Nashana Suktha – 5th Verse, 163rd Suktha of 10th Mandala of Rigveda.
Shayana Bhashya21 interpretes the word Mehana as Medr, which means Shishnya i.e.
Penis on the above mentioned reference.
1. Prameha1 - The word 'Prameha' is composed of two sub-words. i.e.
Pra + Meha
According to the the above verses, it means to excrete urine and semen profusely.
In Sanskrit literatures, the word 'Mih' is used to denote - to make water, to wet,
to ejaculate semen. When the prefix “Pra” is added to the root word 'Mih', the word
becomes Prameha. ‘Pra’ suggests excess or profuse in both Frequency and Quantity.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
So, the word Prameha can be understood as increase in both frequency and quantity of
urine.
“Prakarshena Mehayati Yasmin Roge” - Su. Ni. 6/10
This derivation of word is again substantiated with the Common Clinical
Features of Prameha described as Prabhutamutrata and Avilamutrata. Su.ni.6/6,
A.Hr.ni.10/7.
2. Madhumeha: - The word Madhumeha is derived from two words Madhu and
Meha.
The word Madhu is derived from the root “Manyante Viseshena Jananti Janah
Yasmin”. In Sanskrit literature Madhu word is used with various synonyms in various
contexts like Kshaudram, Kusumasavam, Madhyama, Makarandah, Makshikam,
Madhura Rasa, Jalam, Pushparasa, Kshiram etc - Arunadutta
So, Madhumeha is a disease in which the excretion of urine possesses the quality
similar to that of Madhu (honey) in its colour, taste, smell and consistency. -
Madhavakara.
It means ‘Madhumeha’ is a disease in which a patient passes sweet urine and
exhibits sweetness all over the body i.e in sweat, mucus, breath and blood etc.
PARIBHASHA OF MADHUMEHA:
With the above literary background for the term “Madhumeha”, it can be
defined as a clinical entity in which subject passes large quantity of urine with
Kashaya, Madhura rasa and Ruksha quality similar to the characteristics of honey and
thus body attains sweetness – Acharaya Charaka and Vagbhata.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Acharya Sushruta has narrated the term “Kshaudrameha” in place of
Madhumeha .The “Kshaudra” is one of the varieties of Madhu which is Kapila
(tawny) in colour and hence considered as a synonym to the word Madhu as well. So,
it is clear that Kshaudrameha resembles Madhumeha. As per Sushruta all the varieties
of Prameha; if neglected, get transformed into the pathological streak of Madhumeha.
SYNONYMS:
Few of the synonyms of Madhumeha mentioned in the ancient classics are
follows:
OJOMEHA: This is one among the four sub-types of Vataja Prameha.
Vitiated Vata dosha causes diminution of Ojas through which, the urine along with
the change in its taste and texture finally results in Ojomeha.
KSHAUDRAMEHA: This term has been used by Sushruta because of its
close resemblance with Madhu – Acharya Sushruta.
PAUSHPAMEHA: In Anjana Nidana, the word Paushpameha has been used
in place of Madhumeha. In Sanskrit literature, Paushpameha means Madhu.
ETYMOLOGY OF DIABETES MELLITUS
The word diabetes is originated from the French word named “Jiyabatis” which
means punctured pitcher or pitcher with leak, so that water sprinkles out of it.Diabetes
– Parashuram Shastry.
The word diabtes mellitus contains two words i.e diabetes and mellitus. In Greek
Diabetes means to run through a siphon and the term Mellitus means honey.
WHO APPROVED DEFINITION OF DIABETES MELLITUS:
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Diabetes Mellitus is a group of metabolic disorders characterized by chronic
hyperglycemia associated with disturbances of carbohydrates, fat and protein
metabolism due to absolute or relative deficiency in insulin secretion and /or action23.
SYNROME X or METABOLIC SYNDROME is a cluster of cardiovascular risk
factors that frequently coincides with insulin resistance and hyperglycemia. The
metabolic syndrome is a common condition, associated with genetic predisposition,
sedentary lifestyle, obesity, and aging23.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
NIDANA
Nidana is the specific core pre-disposing factor of a disease. The cycle of
pathology and severity of the disease considerably revolves around the type and
severity of the predisposing factors in relation to the tridosha respectively.
Ayurvedic classics elaborately describes about the general etiological factors
of Prameha at the same time it is the highness of discretion elucidated by Acharya
Charaka in relation to this disease which even though is Tridosha in origin but it is
influenced by specific doshic etiologies which inturn decides the extent and strength
of the corresponding disease pathology leading to Madhumeha latter –Vikara Vighata
Bhava Abhava Prativishesha. Hence, classical etiologies mentioned for Prameha can
be taken for Madhumeha also. Etiological factors of Prameha can be classified into
Sahaja and Apathyanimittaja.
I. Sahaja Prameha: Sahaja Prameha is further divided in to Kulaja and
Garbhaja.
A. Kulaja Prameha:
It is due to defects in Stri & Pumbeeja (Ovum & Sperm) which is said to be Matru-
Pitrukrita Beejadosha finally resulting in Sahaja Prameha. This Beeja Dosha
highlights the relevance of Kulanupatini Prakruti and may have its origin from parents
of both father and mother i.e. it may be inherited from generation to generation and
thus it is a unique example of hereditary disease.
B. Garbhaja Prameha:
Acharya Charaka opines that indiscrete excessive indulgence of Madhura Rasa
by garbhini is the chief cause for the changes and damages in the foetus. Over
indulgence in Madhura Rasa by mother during pregnancy is likely to induce Prameha.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Regarding Sahaja Prameha, genetic predisposition occurring in diabetes has
been well established based on various genome studies in conventional science. Study
focus is mainly on β-cells of islets of langerhans and the blood vessels.
Simultaneously, the metabolic functions leading to the rapid conversion of glucose
into fatty acid forming the adipose tissue have been suspected to have genetic origin.
These variations are due to variation of structure and function of chromosomes. Even
after having genetic predisposition; the stage of overt diabetes may take time to
precipitate – highlighting the concept of Lakshya Nimita1.
Hypothetically, indiscrete excessive intake of Madhura Rasa bring about
changes at the level of gene and thus provide a genetic pre-disposing condition in the
subject and again intake of excessive Madhura Rasa by the pre-diabetic subject in his
early life also precipitates Prameha. Thus; Beeja Dosha and Apathya, both play a
combined role in the causation of Sahaja Prameha.
II. Apathyanimittaja Prameha: Various opinions regarding the discription of
Apathyanimittaja Prameha by different Acharyas are described as follows,
Charakoktha Apathyanimittaja Prameha Nidana:
Asyasukham: Sedentory Sexual Habits and Sedentary Sitting Habits.
Swapnasukham: Sedentary sleeping habits.
Excessive indulgence in Dadhini: Curd and its various preparations.
Gramya, Audaka, Anupa Mamsa: Meat of domestic, aquatic, wet land animals.
Payamsi: Excessive use of milk and its preparations
Nava Annapanam: Excessive use of new grains and drinks.
Guda Vaikrutam: Jaggery and its various preparations.
Along with the above etiological factors, all regimens which vitiate Kapha
dosha should also be considered as the cause for Prameha.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Dravya Properties Dosha Prabhava Koolachara (living at river
side) Eg. Gaja, Gavaya, etc.
Madhura Rasa & Vipaka
Sheeta Veerya, Snigdha Guna
Mutrala & Kapha
Vardhak
Plava (Birds which swim)
Eg. Hamsa, Kroucha etc.
Sheeta Veerya, Snigdha Guna,
Madhura Rasa and vipaka
Mutrala & Kapha
Vardhaka
Koshastha (Live in burrows)
Eg. Shanka, Shukti etc.
Madhura Rasa & Vipaka,
Sheeta Veerya Snigdha Guna
Kapha Vardhaka
Padina (which have limbs)
Eg. Koorma etc.
Balya Mutrala
Matsya Nadeya
(Fishes of river)
Madhura Rasa, Snigdha and
Guru Guna
Shleshma
Samudra (Fishes of sea)
Eg. Timingala, Kulisha etc.
Guru, Snigdha, Ushna, guna, Madhura Rasa, and Vipaka
Shleshma
CHART: GRAMYA, OUDAKA AND ANUPA MAMSA RASA
Sushrutoktha Apathyanimittaja Prameha Nidana:
Acharya Sushruta opines in terms of Snigdha (unctuous), Medya (fatty) and
Drava (liquid) type of food as the causative factors.
Vagbhatoktha Apathyanimittaja Prameha Nidana:
Acharya Vagbhata opines in terms of Madhura, Amla, Lavana Rasa
predominant diet and sedentary habits which increase Medas, Mutra and Kapha as the
causative factors.
DOSHANUSAARA NIDANA VISHESHA:
Kaphaja Prameha Nidana
The following are the etiological factors which help in the immediate
manifestation of Prameha due to Kapha dosha - Frequent and excessive intake of
fresh corns like Hayanaka, Yavaka, Chinaka, Uddalaka, Naishadha, Itkata,
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Mukundaka, Mahavrihi, Pramodaka and Sugandhaka; Intake of Pulses like fresh
Harenu and Masha with ghee; Intake of the meat of domestic, marshy and aquatic
animals; Intake of vegetables, Tila, Palala, Pishtanna, Payasa (a type of sweet
preparation), Krishara, Vilepi and preparations of sugarcane; Intake of milk, fresh
wine, Immature curd and its preparations; Avoidance of unction and physical
exercise; Resorting to inappropriate sleeping habit and sedentary habits; Resorting to
such regimens which produce more of Kapha, fat and urine.
Pittaja Prameha Nidana
Intake of Ushna, Amla, Lavana, Kshara and Katura Dravyas; Intake of food
before the digestion of the previous meal; Exposure to excessively hot sun, heat of
the fire, physical exertion and anger; Intake of mutually contradictory food articles.
Vataja Prameha Nidana
Excessive intake of Dravyas having predominantly Kashaya, Katu, Tikta Rasa,
Ruksha, Laghu and Sheeta Veerya; Excessive indulgence in sex and physical
exercise; Excessive administration of Vamana, Virechana, Asthapana and
Shirovirechana; Resorting to suppression of the manifested urges, fasting, assault,
exposure to sun, anxiety, grief, excessive blood letting, keeping awake at night and
irregular postures of the body.
Specific Etiology of Madhumeha:
The person indulging in food substances having Guru, Snigdha qualities and
excessive indulgence of Amla and Lavana Rasa substances and Navannapana,
excessive sleep, sitting in a same place for longer duration, avoiding exercises –
physical and mental exercises and also not resorting to the Shodhana process at proper
time or even resorting to the latter at improper time.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Acharya Sushruta has narrated that untreated Prameha in its initial stage, gets
converted into Madhumeha and becomes incurable.
According to Acharya Vagbhata, the urine of Madhumehi will be simulating
with that of Madhu. Two type of Vata vitiation has been mentioned, one is due to
Dhatukshaya and second due to Margavarana.
According to Acharya bhela, this disease is of two types based on the specific
etiologies like
1) Prakruthi Prabhaavam
2) Narasya Swakrutham
Etiopathogenesis according to modern medicine:
The etiology of Diabetes mellitus has yet to be understood in spite of the
advances made in the knowledge obtained with respect to various factors associated
with the causation of Diabetes mellitus. Based on the etiological factors Diabetes
mellitus can be classified into two main types namely,
1. Primary or Idiopathic Diabetes: Which is further subclassified into
Type I Diabetes or IDDM and Type II Diabetes or NIDDM.
2. Secondary Diabetes Mellitus.
Causes for Primary Diabetes Mellitus:
A. Genetic Factors:
a) Genetic susceptibility in IDDM:
IDDM is a heterogenous disorder in wich several factors may play a role.
IDDM tends to be a familial disorder and there is a 25-fold increase in the risk
amongst the siblings than the general population. Its inheritance is strongly related to
HLA loci on chromosome-6. It is seen that HLA B8, B15, B6, B21, BW3, DR3 and
DR4 are associated with a higher risk of diabetes. In Indians and Japanese IDDM
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
appears to be associated more with HLABW21 and BW54. Among identical twins
only 50% shows concordance for IDDM as against 100% for NIDDM.
b) Genetic Susceptibility in NIDDM:
Role of genetic factors in etiology of NIDDM has been appreciated ever since
the recognition of the disease, but the pathogenesis is less well understood. The
disease is not linked to any HLA genes as in Type I Diabetes. Though NIDDM occurs
in families, modes of inheritance are not known except for the variant termed
Maturity Onset Diabetes of the Young (MODY), which is due to three different gene
mutations. MODY 1 gene is located on the long arm of chromosome 20 and that for
MODY 3 is on the long arm of chromosome 12 while that of MODY 2 is due to
mutation of glucokinase gene located on the short arm of chromosome 7. It is highly
likely that ordinary NIDDM is polygenic.
B.Immunological Factors (Auto immunity):
The pathogenesis of Diabetes Mellitus mainly depends on the factors insulin
and its source, the β-cells. There is no evidence that Auto-immune mechanisms are
involved in the manifestation of Type II Diabetes (NIDDM) where as IDDM is a
slowly progressive T-cell mediated Auto-Immune disease. Hyperglyceamia
accompanied by the classical symptom of Diabetes occurs only when 70-90% of β-
cells have been destroyed. Islet cell antibodies can be detected before the clinical
development of type-1 Diabetes and disappear with increasing duration of diabetes.
Presently these antibodies are neither used for screening nor for diagnostic purposes,
but glutamic acid decarboxylase(GAD) antibodies may have a role in identifying late-
onset type-1 Diabetes in middle-aged people(Latent Autoimmune Diabetes in Adults-
LADA).
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Although; recent studies reveal that approximately 10% of IDDM patients also
suffer from other Organo-Specific Autoimmune Disorders like Graves’s disease,
Addisions disease, Thyroiditis or Pernicious Anemia, there appears to be a broad
spectrum derangement of immunoregulation in these patients. By the time Overt
Diabetes develops, most of the insulin producing cells of the pancreas - β-cells will be
destroyed completely or will have disappeared.completely.
C. Environmental Factors:
The environment insult or factors may be the cause for manifestation of
Diabetes Mellitus. In many cases the environmental factor is believed to be a viral
infection of the beta cell. Epidemiological studies have linked viral infection with
IDDM. A viral etiology was originally suggested by seasonal variations in the onset
of the disease and by what appeared to be more than a chance relationship between
the appearance of diabetes and preceding episodes of mumps, measles, and congenital
rubella, Coxsackie’s B virus, hepatitis, infectious mononucleosis. The isolation of a
Coxsackie’s virus B 4 from pancreas of a previously healthy boy who died after an
episode of Ketoacidosis and induction of diabetes in animals inoculated with isolated
virus, also suggests a viral etiology. Further the support for viral theory comes from
observations that about 1/5th individuals with congenital rubella develop IDDM.
Viruses may damage the beta cells by direct invasion or by triggering an auto immune
response. They may also persist with beta cells and cause long term interference with
metabolic and secretory functions. While viruses do not produce IDDM in all infected
individuals, it is tempting to speculate that in susceptible individuals these infective
agents trigger a host of immunological phenomena resulting in beta cell death. The
viral theory should be treated with considerable caution. Serologic studies seeking
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
evidence of recent viral infection in patients with new onset IDDM are in conclusive
at best.
D. Diet:
Circumstantial evidence supports the proposition that dietary factors may, at
least in certain circumstances, influence the development of Type I Diabetes. It has
been suggested that exposure to cow’s milk or milk products early in life predisposes
to autoimmune Diabetes. The proposed environmental trigger is Bovine Serum
Albumin, operating through the mechanism of molecular mimicry. In the initial study
diabetic subjects were found to have antibodies to bovine albumin and an antibody
subset specific for a 17 amino acid epitope showed to the strongest association with
the disease. Exposure to cow’s milk in presumed to induce an immune response to 17
amino acid fragment in some infants, and cross β cells expressing the P 69 antigen.
This hypothesis has not received wide support.
Various chemical agents like pentamidine, vacor (rodenticide) and various
Nitrosoamines found in smoke and curried meat have been proposed as potentially
diabetogenic factors.
E. Age:
It is also one of the important risk factor in manifestation of Type II Diabetes.
Type II Diabetes is principally a disease of the middle aged and elderly (>40yrs).
Recently age of onset of Type II Diabetes mellitus is decreasing and is seen in
children and adolescents (i.e. <25 years- MODY) 29
F. Obesity:
Particularly central obesity and a change to western style are inevitable
accompaniment of modernization and it is one of the leading causes for manifestation
of Diabetes Mellitus of Type II variety particularly in India. Obesity probably acts as
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
a Diabetogenic factor (through increasing resistance to the action of insulin) in those
genetically predisposed to develop Type II Diabetes.
G. Life Style:
The sedentary life style with diminished physical activity combined with
overeating and obesity is associated with development of Type II Diabetes Mellitus.
H. Stress:
Stress may be a possible link factor for Diabetes either through a direct effect
on the Neuro-endocrine system by stimulating the secretion of counter regulatory
hormones and possibly by modulating immune activity or indirectly through the cycle
of overeating and subsequent development of obesity that may be associated with
stress 25.
I. Malnutrition in utero:
It is proposed that malnutrition in utero may programme beta cell development
and metabolic function at a critical period, so predisposing to Type II Diabetes later in
life.
Causes for Secondary Diabetes Mellitus:
Pancreatic Disease:
Acute and Chronic pancreatitis, Post Pancreatectomy, congenital pancreatic
aplasia, pancreatic carcinoma, cystic fibrosis and Haemochromotosis are few of the
conditions which manifests Secondary Diabetes Mellitus.
Hormonal Abnormalities:
The hormones such as Growth Hormone, Glucocorticoids, Catecholamines,
Thyromine and Glucagon cause impaired Glucose Tolerance or even an overt
Diabetes, as they have insulin antagonistic effect. Conditions such as Acromegaly,
Cushing’s syndrome, and Phenochromocytoma can cause Diabetes, especially in
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
those persons who are prone. It may also arise due to therapeutic administration of
Steroidal Hormones. Stress hyperglycemia associated with severe burns, acute
myocardial infraction and other life threatening illness, is due to excessive release of
Glucagon and Catecholamines.
Drugs and Chemical induced Diabetes:
Drugs or Chemicals can either impair insulin action or damage the beta cells
causing decreasing in the insulin secretion. Drugs like pentamidine and vacor are beta
cytolytic, where as glucocorticoids and nicotinic acid increase the insulin resistance.
Insulin Receptor Abnormalities:
Rare conditions associated with mutation in the insulin receptor or the post
receptor pathway leads to manifestation of Diabetes mellitus. The individuals have
extreme degrees of insulin resistance and are associated with Acanthosis Nigrican’s,
polycystic ovaries and rarely virilization. Leprenchaunism could be fatal and patients
do not cross the infancy.
Genetic Disorders:
Many genetic syndromes are associated with Diabetes. Down’s syndrome,
Klinefelter’s syndrome, Turner’s syndrome and Wolfram’s syndrome are some
important ones.
Role of Endocrine Glands:
Pituitary Gland14: The pituitary hormones can influence the course of Diabetes
Mellitus. The growth Hormone of pituitary has the diabetogenic power.
Administration of hormone leads to hydropic changes in beta cells associated with an
early reversible phase of Diabetes followed later by an irreversible phase with
complete destruction of beta cells. Diabetes may be associated with Acromegaly.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Adrenal Gland14: Adrenalectomy will arrest or modify the progress of experimental
Diabetes. The onset of Addisson’s disease has an ameliorating effect on the human
variety. Adrenal Hyperplasia or tumors may be associated with Diabetes.
Gestational Diabetes: Gestational Diabetes is defined as any degree of glucose
intolerance with onset or first recognition during pregnancy. During normal
pregnancy, insulin sensitivity is reduced through the action of placental hormones and
this affects the glucose tolerance. The insulin secreting cells of the pancreatic islets
may be unable to meet this increased demand in women genetically predisposed to
develop Diabetes. Repeated pregnancy may increase the likelihood of developing
irreversible Diabetes, particularly in obese women. However the patient should be
evaluated after six weeks after delivery and reclassified as either diabetic or non
diabetic.
Nidana similarities of modern view with ayurveda:
The atiological factors mentioned by modern medicine are also in concordance
with ayurvedic scholars. Both systems agree regarding genetic elements associated
with DM. According to modern view and ayurvedic view sedentary life habits play an
important role. Both systems deal with Medo Dhatudushti Nidana as a cause for DM.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Table No: 1 Similarities of Nidana in Modern and Ayurveda
MODERN VIEW AYURVEDIC VIEW
Genetic susceptibility is identified. One variety of prameha is Sahaja due to
Sukra and Artava Dosha.
Sedentory life habits are a prime
cause.
Ayurveda also mentioning the same like
Asyasukham, Swapna Sukham etc.
Diabetis has been discribed as
complication of Obesity due to insulin
resistance caused by fat globules.
Charaka also describes Prameha as a
Complication of Sthoulya.
Dietary factors influence development
of type1 DM.Some Diabetogenic
factors like bovine serum albumin
found in cow’s milk, nitrosamines
present in smoked and cured meat has
been identified.
Indiscrete use of Cows milk, Gramya
Mamsa, Anoopa Mamsa are considered
as major Nidana for Prameha by Charaka.
Mental factors like stress have been
accepted as a principal atiology.
Acharya Charaka explains as Krodha is a
predisposing factor for Pitha Prameha and
mental strain like Udvega and Soka will
cause Vataja Prameha.
Environmental factors enhance viral
infections and leads to diabetes have
been described.
Excessive Vata Pita Prakopa
environments like Atapa Sevana, Agni
Santapa etc have been described.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
PURVARUPA
Purvarupa are the most valuable prodromal signs and symptoms that signal the
forth-coming disease. Every disease has its own characteristic Purvarupa and become
manifested at the stage of Sthanasamshraya and it is one kind of warning signal to the
subject to restrain from those activities which triggers Prameha. As Madhumeha is
classified under the Vatika type of Prameha, Purvarupa of Prameha can be taken as
Purvarupa of Madhumeha1.
Table No 3. Purvarupa of Madhumeha, according to different Acharyas.
Purvarupam Cha17 Su20 A.H27 A.S28 Ma.Ni29
Kesheshu Jatilibhava + + - + -
Asya Madhurya + - + + +
Karapadadaha + + + + +
Karapada Suptata + - - - -
Mukha Talu KanthaShosha + - + + -
Pipasa + + - + +
Alasya + - - + -
Kaye malam + - - + -
Kaya Chhidreshu Upadeha + - - + -
Paridaha Angeshu + - - - -
Suptata Angeshu + -- - + -
Shatpada Pipilika
Mutrabhisaranam
+ - + + -
Mutre Cha Mutra Dosham + - - - -
Visra Sharir Gandha + + + + -
Sarvakala Nidra + - - + -
Sarvakala Tandra + + - + -
Snigdha Gatrata - + - + -
Pichhila & Guru Gatrata - + - - -
Madhur Mutrata - + - - -
Shukla Mutrata - + - + -
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Sada - + - + -
Shwasa - + - + -
Keshanakhativriddhi + + + - -
Sheeta Priyata + - + + -
Hridaya Netra Jihwa
Shravanopdeha
- - + - -
Sweda + - + + -
Dehe Chikkanata - - - - +
The manifestation of the above mentioned prodromonal symptoms can be
understood in co-relation to the stage of Sthanasamshraya where the already vitiated
and dislodged bodily principles starts to find its substratum vide srotas and its
appendages for the development of further pathogenesis within the latter and finally
enabling the process of Atura Samvedhya and Vaidya Samvedhya Lakshanas which
inturn helps the physician to assess the srotas and its appendages afflicted and plan for
appropriate therapeutic measures based on the Dushyadi Sameekshya Bhava9.
Unexplained fatigue and weight loss has been clinically considered as prodromal
symptoms by modern physicians29.
It is in the nature of this disease; Madhumeha, which withholds the global
systemic illness within its claws that these above mentioned prodromal symptoms
themselves extend to become the cardinal clinical features of the disease. So for the
early diagnosis of this disease – Madhumeha, these prodromal symptoms mentioned
for Prameha - Madhumeha play a pivotal role in guiding and planning the further
course of therapeutic measures with the discretion of the physician based on the
Vikara Vighata Bhava Abhava Prativishesha1.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
RUPA
The manifesting symptom of a disease which bears its characteristic features is
called Rupa. It represents the Vyakthavastha of Shatkriyakala. Acharya Gayadasa
opines that in case of Prameha, Purvarupa will be manifested as Rupa. This type of
manifestation is termed as Vyadhi Prabhava.
According to Sushrutacharya, the person should be diagnosed as Pramehi
when complete or partial prodromal symptoms of Prameha accompanied by
Prabhoota mutrata get manifested.
Important Samanya Lakshnas of Prameha w.s.r to the Urine
Characteristics:
1) Prabhuta Mutrata (Quantity):
It is considered as the cardinal sign of Prameha by all Acharyas. Acharya
Gayadasa opines on Su.Ni.6/6 that excess urine quantity is because of liquefaction of
the Dushyas and their mutual amalgamation.
It may be suggested that the Prabhuta Mutrata is more akin to metabolic
changes. The excessive urination helps in the elimination of excessive accumulation
of carbohydrate, protein and fat metabolites. The excessive urination is due to an
improper metabolism of carbohydrates, proteins and fats resulting in water and
electrolytes imbalance.
2) Avila Mutrata (Turbidity):
Patient passes urine having hazy consistency. Gayadasa and Dalhana opine
that, the characteristic features of urine are because of the amalgamation between
Mutra, Dosha and Dushya.
Avila Mutrata is more akin to urinary pathology. This Avila mutrata i.e.
turbidity of urine occurs due to body reaction with the Doshas. This can be due to
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
presence of phosphates, sugar, sperm, acetone, silicates, albumin, chyle, bile pigments
and salts, blood, pus or casts etc. in the urine. Observed facts contribute to the opinion
that quantity of the urine may remain normal or may be reduced in the later stage of
this disease which in turn depends upon the habit of liquid intake. So, both the
symptoms have been considered as the Cardinal Clinical Features of this disease by
Ancient Seers.
3) Pichhila Mutrata (Consistency):
At the time of diagnosis, Charaka mentioned to consider the etiological factors
also to assess the involved Dosha after knowing the character of urine like Pichhilatha
and Madhurya.
Acharaya Sushruta has described two types of Prameha along with their
manifestations as follows
Sahaja Pramehi (Krisha-Asthenic)
Ruksha (Dry body)
Alpashi (Consumes less food)
Bhrish Pipasa (Voracious thirst)
Parisarpansheelata (Restless, always desires to wander)
Apathyanimittaja (Sthula-Obese)
Bahuashi (Voracious eater)
Snigdha (Unctuous body texture)
Shayyasanswapnasheela (Like to sit down & sleep always)
Acharya Kashyapa has described the following Rupas for Prameha.
(a) Akasmata Mutra Nirgama: Excretes urine suddenly without any intention.
(b) Makshika Akranta Mutra: Flies get attracted towards the urine.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
(c) Shweta and Ghana Mutrata: Passes urine having white colour and of turbid nature.
Along with the above he has also narrated symptoms like Gaurava (Heaviness of the
body), Baddhata (tightness) and Jadata (Procrastination).
Specific Lakshanas of Madhumeha: (Visesha Rupa)
Urine Characteristics:
Madhumehi passes urine having Kashaya and Madhura taste, Pandu Varna
and Ruksha quality. Gangadhara opines on this that the Madhura Rasa of Ojas is
displaced by Kashaya Rasa. Chakrapani opines that Vata, because of its Prabhava
converts Madhura Ojas into Kashaya Ojas.
According to Sushruta, the urine of Madhumehi resembles with that of honey,
as described above. Similar description is found in Ashtanga Hridaya and Ashtanga
Samgrahakara.
CLINICAL FEATURES OF DIABETIS MELLITUS:
Type I Diabetes Mellitus:
Type I Diabetes Mellitus usually begins before age 40 years. This type of
Diabetes is characterized by a rapid onset, with symptoms such as Polydypsia,
Polyuria, Polyphagia, weight loss associated with Random Plasma Glucose level ≥
200 mg/dl. In the fulminating case, the most striking features are those of salt and
water depletion i.e. loose dry skin, furred tongue, cracked lips, tachycardia, and
hypotension and reduced intraoccular pressure. Breathing may be deep and sighing
due to acidosis, the breath is usually fetid and the sickly sweet smell of acetone may
be apparent. Once the symptoms develop, Insulin therapy is required. Occasionally an
initial episode of Ketoacidosis is followed by a symptom free interval (the
“honeymoon” period), during which no treatment is required.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Type II Diabetes Mellitus:
Type II Diabetes Mellitus usually begins in middle life or later. The typical
patient is overweight. Symptoms begin gradually. Candidal vaginitis or Pruritis
vulvae29 or balanitis is a common presenting symptom since the external genitalia are
especially prone to infection by fungi (Candida) which flourish on skin and mucous
membranes contaminated by glucose due to varied pH within the vaginal canal.
Blurred or decreased vision due to retinopathy is found due to the prothrombotic and
platelet aggregation caused by the endothelial dysfunction. Depression or loss of
tendon reflexes at the ankles and impaired perception of vibration sensation distally in
the legs indicate neuropathy caused due to the accumulation of AGEs which are
neurotoxic in nature25. Hypertension and signs of atherosclerosis are common and
may include diminished or impalpable pulses in the feet, bruits over the carotid or
femoral arteries and gangrene of the feet. Signs of dehydration with associated altered
consciousness are recently noted in cases with severe hyperglycemia. Clinical features
can be classified as follows,
TableNo.4 Clinical Features of Diabetes Mellitus29
SYMPTOMS TYPE – I TYPE – II
Polyuria and thirst ++ +
Weakness or fatigue ++ +
Polyphagia with weight loss ++ -
Ketoacidosis ++ +
Impotency ++ +
Nocturnal enuresis ++ -
Recurrent blurred vision + ++
Vulvovaginitis /Pruritis Vulvae + ++
Peripheral Neuropathy + ++
Often asymptomatic - ++
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
We can find more similarities between ayurvedic and modern perception over
the clinical features of Madhumeha vis a vis Diabetes Mellitus like Polyuria -
Prabhutamutrata, Polydipsia - Pipasa Adhikata, Polyphagia – Kshudha Adhikata
etc. They have been discussed as follows,
TableNo.5 Similarities of symptoms in Modern and Ayurvedic views:
MODERN VIEW AYURVEDIC VIEW
Polyuria Prabhutamutrata
Polydipsia Pipasa Adhikata
Weakness and fatigue Dourbalya
Polyphagia Kshudha Adhikata
Glycosuria Avila mutrata - Mutramadhurya
Lassitude Alasya
Increased turbidity and specific gravity
of urine.
Avilamutrata
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
SAMPRAPTI
Samprapti of a disease can be literally understood as the process of obtaining
the complete purview of a disease by bridging the discipline of basic fundamental
principles with the clinical observation by studying the specific patterns of vitiation
related to the doshas and dushyas underlying a disease due to its variety of Nidana
and its successive sequential events through the mode of Prasara and
Sthanasamshraya in to various parts or visceras of the body upto the ultimate
expression of the diseased condition and its complications. This indeed due to the
technological advances has become more exciting scientifically and also gained more
importance in relation to the selection of medicine especially in our stream of
medicine – Ayurveda, since all therapeutic modalities are aimed at breaking up this
vicious cycle of pathogenesis -“Samprapti Vighatanameva Chikitsa.”
For the manifestation of any disease condition in the body, the important three
inter-connected factors are Nidana, Dosha and Dushya. Likewise; when these three
factors are not well established within the body, then the occurrence of the disease
will be questionable. The Nidana - Gurvadi, Dosha - Vatadi, and Dushya - Rasadi are
responsible for the manifestation or non-manifestation of the disease. If the Inter-
relationship or Paraspara anubandha of the above three factors are of Hina Bala and
are not connected to each other; then, the chances of manifestation of the disease will
be of considerably low. If these three factors are having less strength and connected
with each other then the manifested disease will not have all the signs and symptoms.
If they are complete and with full strength and their inter-connection is strong enough;
then, the disease occurrence and manifestation can be termed as the Status Ultimatum
with complete clinical manifestation of the disease. However, this in relation to the
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Diabetes Mellitus is termed as Overt Diabetes and possibly can be related to the
Asadya state of the disease Madhumeha.
Prameha vis a vis Madhumeha is included in the group of diseases which are
established in the body due to Santarpana. Charaka Acharya has well established the
sequential events occuring in the process of establishment of the disease by explaining
the Dosha Dushyadi Samprapthi Ghatakas in detail. For better understanding of
Madhumeha Samprapti it is worthy enough to discuss in detail regarding various
patterns of Prameha Samprapti since the other facet of this condition Madhumeha
includes as a category of Vatika Prameha.
Some important points in this concept are natural Kapha in the Prakruta
Avastha is responsible for the existence of Apara Ojas and its corresponding function.
Here in Prameha Samprapti it gets disturbed due to respective preceding etiological
factors mentioned for the vitiation of the dosha, particularly Kapha Dosha.
The Dushya Sangraha is Meda, Mamsa, Shareera Kleda, Shukra, Shonita,
Vasa, Majja, Lasika, Rasa and Ojas. The special characteristic features of these
Dushyas are elicited to be Bahvabadha form.
Due to Nidana Sevana Kapha Pradhana Tridosha Prakopa occurs and Apara
Ojas in Bahudrava Kapha form vitiates Shareera Kleda, Meda, and Mamsa etc. It
further vitiates to reach the Sthanasamsraya stage within Basti along with the Dushyas
and produce Kaphaja Meha. When Kapha Kshaya occurs it will began to vitiate Pita
Dosha and its Anubandha Dushya. As a result Pitha Kshaya occurs and lastly Vata
Pradhana Dosha Dushti occurs and results in Vataja Prameha. These above
descriptions are liable for discretion based on Vyapadeshastu Bhuyasa rule.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
ChartNo.1 SAMPRAPTI OF MADHUMEHA - VARIETY 1
Dushana of Kapha by Nidana
Sahaja Prameha Apathya Nimitaja
Bahudrava Kapha
Dushana of Meda, Kleda, Mamsa etc
Bastiprapti of Dosha and Dushya
Kapha Prameha
Pitha Prameha
Vata Prameha
The above mentioned pattern is the gradual development of the Madhumeha
either through Avarana or Dhatu Kshaya. In other words the Samprapti of Meha can
be discreted according to the Dushyas involved and the dominating Dosha involved.
The possible streak of pathology from Kaphaja Meha to Vatika Meha based on the
Gati and Pradhanata of Dosha, Dushya Samurchana can be explained as follows in the
table.
TableNo.6 Ashraya Ashrayi Bhava9
Dosha Prakopa Dushya Meha produced
Kapha Rasa, Mamsa, Meda, Ojas Kaphaja
Pitta Rakta Pitaja
Vata Remaining Pradhana Dhatus (Vasa, Majja, Lasika,)
Vataja
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Samprapti of Kaphaja Prameha:
After giving a clear picture of these common factors, Acharya Charaka begins
with the causative factors of Kaphaja Meha. With the specification of some Aharas
and Viharas which lead to Kapha Vrudhi, he concludes them by saying that all those
factors which lead to the Vrudhi of Kapha Meda and Mutra are included in the
Nidanas of Kaphaja Meha.
Due to Nidana Sevana the Kapha Dosha undergoes provocation and
Medomamsadi Dushyas are getting vitiated. When these two events occur the Kupita
Kapha – Apara ojas spreads easily and this spreading of Dosha is supported by Ojo
Visramsa and Ojo Vyapath Lakshanas. The affinity of Kapha Dosha towards the
factors of same quality plays an important role here. The liable Medo Vikruthi having
Samanya Bhava with Kapha Dosha combines together. Kapha Dosha due to its
vitiated nature vitiates Medo Dushya also.
The further course of these combo factors in the body is to vitiate the Shareera
Kleda, Mamsa and Vasa due to few Samanya Bhava, this further lead to Vrudhi of
Sharira Kleda and Mamsa dushti. Within this stage of Mamsa Dushti, Rakta Dhatu
and its appendages gets afflicted due to the varied involvement of vitiated pita dosha
which in combination with the above combo factors are responsible for vitiation of
Sveda and Medas in the body successively to create a sufficient amount of Mala
Sanchaya within the disturbed Koshta. All these together inclines towards the
acquisition of Samalatva form of Mutra which is guided towards the corresponding
Mutravaha Srotas to establish the Samanya Lakshana of this condition.
Samprapti of Pitaja Prameha:
Basically the Samprapti of Pitaja Meha is same as that of Kaphaja but the
Nidana which directly provocate Pita Dosha, the latter dosha pita and the affinity
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
towards the respective Dushya Dushti with the predominance of pita dosha and
associated with the kapha and vata dosha in establishing varied degrees of clinical
manifestation.
Samprapti of Vatika Prameha:
When an individual who’s Mamsa, Meda, Kleda are already vitiated is
exposed to the Nidanas of Vata Dosha Prakopa, it directly lead to Vatika Prameha.
The Nidana are those which affect Sharira Bala very much like Ativyayama, improper
Shodhana Chikitsa, Atiyoga, Shoka, Bhaya etc. This is the condition when Vata
Dosha undergoes provocation. Then the Kupita Vata Dosha attracted towards the
remaining important Dushyas like Vasa, Majja, Lasika and Ojas. These vitiated
factors reach basti and are eliminated in Mutra form.
Samprapti of Madhumeha1:
Acharya Sushruta opines that if Prameha vis a vis Madhumeha is not treated in
time, they gradually pass to Asadya stage of Madhumeha. Acharya Charaka has
described Madhumeha vividly based on the Vikara Vighata Bhava Abhava
Prativishesha principle. Vagbhata divides Madhumeha into two types, according to
Samprapti. The Asadya variety of Madhumeha is included in Vataja type. If Vata
Prakopa occurs due to Sarvadhatukshaya, it is called Dhatukshayajanya Madhumeha.
And if Vata prakopa manifests as result of Avarana, it is termed as Avaranajanya
Madhumeha.
Different mode of Samprapti of Madhumeha:
The pathogenesis of Madhumeha is explained in Charaka Samhita,
Nidanasthana 4th chapter. Due to causative factors in the person susceptible for
Prameha, Vatakopa occurs. This Kupita Vata Dosha attracts the vital and deep seated
Dhatus like Vasa, Majja, Lasika and Oja to Basti. The Vata Dosha is having
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Rukshatva and it again changes the Madhura Rasa of Oja into Kashaya Rasa. This
Kashaya Oja is excreted through urinary tract later.
Chart No.2 – SAMPRAPTI OF MADHUMEHA - VARIETY 2
a) Madhumeha Due to Kevala Vata:
Due to the Kapha and Pita Kshaya, and with the Kshaya of Vasa, Majja,
Lasika and Ojas, Vata Dosha gets aggravated and draws Ojas towards basti leading to
Madhumeha.
b) Dhatukshayajanya Madhumeha:
The Kshaya of vital dhatus Vasa, Majja, Lasika and Ojas leads to
Vataprakopa. This vitiated vata further makes Ksharana of these dhatus through
Mutravaha srotas resulting in Vasameha, Majjameha, Hastimeha and Madhumeha
respectively. When Kapha and Pita gets depleted Vata gets provocated and it leads to
depletion of Dhatus.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
c) Avaranajanya Madhumeha:
Aharas with the predominance of Guru, Snigdha, Amla and other
Kaphapitakara Nidana leads to the provocation of Kapha and Pita doshas. This in turn
vitiates Medas and Mamsa. These increased dosha-dushya cause avarana dosha by
which normal gati of Vata Dosha is disturbed. Finally vitiated vata carry the
circulating Ojas towards basti resulting in the Madhumeha condition.
d) Apratikarita Madhumeha8:
Acharya Sushruta has described that all types of Prameha - Madhumeha, if not
treated in time, gets converted into Madhumeha. This is the later stage of disease.
SAMPRAPTI GHATAKAS:
a) Dosha:
All the three doshas are responsible in producing Prameha- Madhumeha,
based on Vyapadeshastu Bhuyasa rule - Kapha, Pita and Vata respectively.
(i) Kapha:
A. Bahu and Abadha in Avaranjanya Madhumeha
B. Kshina in Dhatukshayajanya Madhumeha
Kapha Dosha- Apara Ojas has the status as dominant dosha in either type of
Samprapti. The first vitiated dosha is kapha - . Acharya Charaka while describing the
Nidana has used the term ‘Kaphakrut cha sarvam’. It indicates the importance of
Kapha Dosha Dushti and the subsequent Ojas disturbance in Meha. Ojo Vyapat
Lakshanas are well appreciated clinically.
(ii) Pita:
A. Vrudha-in Avaranjanya Madhumeha
B. Kshina- in Dhatukshayajanya Madhumeha
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Status of Pita Dosha is Vrudha in Avaranjanya Madhumeha. In this state due
to respective Nidana, Vrudhi Lakshanas will be manifested. In Dhatukshayajanya
Madhumeha, Vata dosha is in the Kupitha state, So lakshanas related to Pita Dosha
Vikruthi and Vata Dosha are quite evident clinically.
Kshudha Adhikata, Atisweda etc. like Pita Vrudhi lakshanas are evident in
Avaranajanya Madhumeha and Mandagni, Prabhahani etc. like Pita Kshaya lakshanas
are found in Dhatukshayajanya Madhumeha.
(iii) Vata:
A. Avruta- in Avaranjanya Madhumeha
B. Vrudha-in Dhatukshayajanya Madhumeha
It possesses Gati and Yogavahi Svabhava. In Madhumeha the provocation of
this dosha occurs in two ways i.e. Margavarodha and Dhatukshaya .This vitiated
dosha then carries the vital dhatus like Vasa, Majja, Lasika and Oja to basti and
results Madhumeha.
Role of Vyana and Apana:
In Su.Ni.1/20, it is described that Vyana and Apana are the main culprits in
Prameha- Madhumeha. Vyana being pervaded all over the body and Apana in
Vankshana, Vyana acts as the collector of Kleda and Apana as Excretor. The
provoked vata carries the dushyas like Vasa, Majja and Ojas towards Basti and
excretes through urine. Again the excretion of dushyas exaggerates vata provocation
and hence the vicious cycle goes on.
b) Dushyas:
Nidana, Dosha and Dushyas are the three factors responsible for the
manifestation of every disease. But when they are having Anukulatva disease
establishes in its way. So Anukulatva of these factors is important in Madhumeha.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
The ten Dushyas described in Madhumeha are Rasa, Rakta, Mamsa, Meda, Majja,
Vasa, Lasika, Oja, Shukra and Ambu38. Vagbhata Acharya includes Sveda as
additional.39
Citation - Charakasamhita Chikitsasthana, Kleda has been referred to as
Ambu. Acharya Sushruta also have considered the above factors.
Meda is common dushya in all Prameha Samprapti. While considering the
Purvarupa at the Sthanasamshraya level, Keshanakhati Vrudhi mentioned refers to the
mala as a result of Asthi Dhatu. Thus almost all the dhatus are involved in this disease
which leads to either Asadhyatva or Krichrasadhyatva.
Rasa: Rasa is the seat of Kapha Dosha. At the same time, the Prakupita Avasta is
considered as mala of Rasadhatu. So vitiation of Kapha is the result of vitiation of
Rasadhatu. The symptoms like Alasya, Gaurava and Karshya are produced as a result.
Rakta: Mainly connected dushya in Pitaja Meha Samprapti. The symptoms and signs
due to its involvement are Daha, Pidaka, and Vidradhi etc.
Mamsa: It is a seat of Kapha Dosha. The vitiated Meda combines with it and results
in Putimamsa pidakas.
Meda: It is the dominant dushya in all types of Pramehas. Both quantitatively and
qualitatively it is vitiated. Abadhatva is qualitative and Bahutwa is quantitative
vitiation. Shareera Shaithilya is produced by Abadha Meda and Bahutwa of Meda
leads to Dhatwagnimandya. Dhatwagnimandya leads to Medo Vrudhi in turn.
Majja: In the Samprapti of Madhumeha, Majja gets depleted as a result of
Vataprakopa. The provoked vata draws Majja towards Basti and excretes through
Mutravaha srotas leading to Majjameha which signifies the highest degree of
vitiation.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Shukra: Shukra is having an important role in Sahaja Prameha. Prameha is a Kulaja
Vikara and occurs as result of Beeja dosha. Vyana and Apana are the causative factors
for Shukra dosha and Prameha. Vata causes depletion of Shukra Dhatu and causes
Shukra Meha.
Ojas: Apara Oja is the one disturbed initially which later in Vataja type of Prameha
vis a vis Madhumeha alters its quality and carries towards basti and excretes through
urine. The manifestations like Gurugatrata, Nidra, and Tandra are the result of Oja
Visramsa and Vyapat which finally at the highest degree of vitiation draws the Para
Ojas to cause death.
Kleda: Kleda itself is an important dushya in Prameha. It makes other dushyas
susceptible for the progression of the Samprapti. Kleda promotes analogy between
Dosha and Dushya. The increased Kleda with Bahudrava Sleshma and Bahvabadha
Meda amalgamates with vitiated Doshas and Dushyas resulting in increased amount
and frequency of the urine along with adding Samalatva to it thus altering its
turbidity, specific gravity and transparency.
Vasa: Vasa, the Upadhatu of Mamsa has been described as the predominant dushya
affected in Vataja Prameha. Vasameha is one type of Vataja Prameha which signifies
the highest degree of vitiation.
Lasika: Lasika is one type of body fluid described as - its dushti will be predominant
in Hastimeha.
Sweda: Sweda has been described as dushya by Acharya Vagbhata. Atisweda and
Visra shareergandha occurs as a result of Sveda dushti along with other dushyas.
(c) Srotas: (Medovaha, Mutravaha, Udakavaha)
Mutravaha srotas is mainly involved in this disease. Medovaha, Mamsavaha
Srotodushti also occurs in Madhumeha. Prabhuta Avila mutrata is a result of
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Mutravaha Srotodushti. Purvarupa of Prameha mentioned like, Kaye Malam, Snigdha
Gatrata, and Pichila Gatrata is the manifestations of Medovaha Srotodushti.
Udakavaha Srotodushti produces symptoms like Pipasa Adhikata, Mukha-Talu-Kanta
Shosha. Sharavika, Kachapika etc. like pidakas gets manifested when Mamsavaha
Srotodushti occurs.
d) Role of Agni and Ama:
Madhumeha is a metabolic disorder which is the result of Dhatwagnimandya.
In Ayurvedic concept Pachana tatvas are Jataragni, Bhutagni and Dhatvagni. When
taken food materials are properly digested it can be absorbed for further building up
of the body. Otherwise a non absorbable form is produced after semi digested stage.
This concept is applicable not only to the food ingested by the individual but also can
be applied to the cellular level. The food which is in the semidigested form is not
capable of entering to the Srotomukhas due to pichila, Guru Guna and can be termed
as Ama. In the case of Dhatvagni it helps in the Parinama of dhatus from rasa to
shukra. When it loses its potency or when it is less, it leads to Dhatuvrudhi and vice
versa. Due to specific nidanas, Agnimandya occurs and it further leads to Bahudrava
Kapha and Bahvabadha Meda. Kleda and mamsa also increases within the same stage.
The concept of Agnimandya is the same in case of Avaranjanya Madhumeha
also. Agnimandya occurs in a same way and it leads to the improper digestion of
excessive dhatus and is not assimilated properly leading to the vitiation of the specific
Dhatu. This vitiated dhatu obstructs gati of vata. Due to Kupita vata, Jataragni
increases and it requires more and more food. This further leads to the tendency to
take more food which in turn leads to Medovrudhi- impaired lipid and protein
metabolism.
Samprapti Ghatakas had been summarized as follows.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Dosha : Kapha Arambhaka Tridoshaja
Dushya: Meda, Mamsa, Shareera Kleda, Shukra, Lasika, Vasa, Majja, Rasa, Rakta
and Ojas1.
Mala: Sveda, Mutra, Kesha, Nakha.
Agni: Jataragni, Dhatvagni
Ama: As the Mandagni leads to formation of Aparipakva Ahara rasa.
Srotas: Medovaha, Svedovaha, Rasavaha, Raktavaha, Annavaha, Mutravaha and
Udakavaha.
Srothodushti: Sanga and Atipravruti.
Udbhavasthana: Amasaya.
Adhishtana: Vapavahana and Vrukkas.
Sanchara Sthana: Mutravaha Samsthana
Vyaktha Sthana: Basti.
Vyadhi Svabhava: Chirakari, Anushangi.
Rogamarga: Bahya Rogamarga as Rasa, Rakta and Mamsa dhatus are involved.
Abhyantara Rogamarga is also involved in the disease as Koshtangas like Amasaya, ,
Pakvashaya, Vrukka etc. are affected – signifying the Global Systemic Affliction.
SAMKHYA SAMPRAPTI OF PRAMEHA (CLASSIFICATION)
Classification of a disease is mainly done for the purpose of proper
understanding of the disease and to formulate an effective treatment protocol. In this
point of view various types of classification of Prameha including Madhumeha has
been described by the ancient Ayurvedic scholars. This has been elaborated as
follows.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
1. Classification based on Nidana (Etiology) 17, 18, 19.
The root cause of disease has enough importance for the prognosis and treatment of
the disease. The occurrence of Madhumeha according to this point of view is of two
types.
A) Sahaja [Heriditary]
B) Apathyanimittaja [Acquired]
A) Sahaja
Sahaja Prameha occurs as a result of Beejadosha i.e. genetic origin16.
While describing prognosis, Acharya Charaka has narrated that Prameha or
Madhumeha occurring due to Beeja dosha is incurable.
B) Apathyanimittaja
Apathyanimittaja type itself suggests its etiology. It occurs due to Ahitahara17.
On analyzing the Samprapti, Apathyanimittaja Madhumeha is of two types.
a) Santarpanjanya: Santarpanjanya Madhumeha which is directly due to intake
of nutritious diet, which are having Kaphavardhaka properties. The excess
intake of such substances will primarily lead to the vitiation of Kapha, Pita,
Meda and Mamsa, which in turn cause Madhumeha by doing avarana of
vata.43
b) Apatarpanjanya: If the substances which deplete the dhatu and aggravate
vata are consumed then it leads to Apatarpanjanya Prameha. They act through
vitiation of vata which in turn leads to the manifestation of Madhumeha.
2. Dosha [Clinicopathological classification]:
Twenty types of Prameha have been described by the different authors of
Ayurvedic Classics. Among these, 10 are of Kaphaja type, 6 are of Pitaja type and 4
belong to Vataja type. They are enlisted below,
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
TableNo.7 – Dosha classification of Prameha- Different views
Types Charaka44 Sushruta45 Vagbhatta46 Madhava47
Kaphaja Meha
Udakameha + + + +
Ikshuvalikameha + + Ikshumeha Ikshumeha
Sandrameha + + + +
Sandraprasadameha + Surameha Surameha Surameha
Shuklameha + Pishtameha Pishtameha Pishtameha
Shitameha + Lavanameha + +
Sikatameha + + + +
Shanairmeha + + + +
Alalmeha + Phenameha Lalameha Lalameha
Shukrameha + + + +
Pitaja Meha
Ksharameha + + + +
Kalameha + Amlameha + +
Nilmeha + + + +
Lohitameha + Shonitameha Raktameha Raktameha
Manjishtameha + + + +
Haridrameha + + + +
Vataja Meha
Vasameha + + + +
Majjameha + Sarpimeha + +
Hastimeha + + + +
Madhumeha + Kshoudrameha + +
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
3. Classification based on Samprapti: According to mode of Samprapti Prameha
especially Madhumeha can be classified in to two.
a) AvaranjanyaMadhumeha48
In Avaranjanya Madhumeha, Kaphavardhaka Nidanasevana leads to vata avarana,
which in turn leads to Ojas Karshana which comes to the basti and patient passes
Madhura, Kashaya, and Ruksha Mutra, which is said to be Madhumeha.
b) DhatukshayajanyaMadhumeha49
Whereas in Dhatukshayajanya Madhumeha, due to Vatavardhaka nidana,
Vataprakopa occurs and the Madhuratva of Oja is displaced by Kashaya rasa and it is
brought to the basti leading to Madhuvat Mutratyaga, leading to Madhumeha.
4. Prognostic Classification: 50
Prognosis is an inevitable part of Chikitsa so far as a wise physician is
concerned. Success of treatment depends on an unbiased prognosis. On the basis of
the prognosis we can classify Prameha as follows.
TableNo.8 Sadhya Asadhyata
Sadhya Yapya Asadhya
Kaphaja Pitaja Vataja
Sthula (Obese) Usually not much obese Krusha (Asthenic)
Apathyanimittaja (Acquired) Acquired Sahaja (Heriditary)
Early Stage Acute Stage Advanced Stage
Without complication With Complication with Complication
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
5. Classification of Prameha- based on physique51
Clinicopathological status of a disease has an invariable relation with physical
constitution of the body in Madhumeha. This has to be taken into consideration when
treatment is formulated. According to this, in Ayurveda, Madhumeha is of two types.
a) Sthula
b) Krusha
PATHOGENESIS OF DIABETESMELLITUS 52
Pathogenesis of type 1 Diabetes Mellitus
This type of Diabetes results from autoimmune destruction of β cell. Three
interlocking mechanisms are responsible for the islet cell destruction. Genetic
susceptibility, autoimmunity and an environment insult. Genetic susceptibility is
linked to specific alleles of the class II major histocompatability complex and other
genetic loci that predispose certain persons to the development of autoimmunity
against β-cell cells of islets. The autoimmune reaction may develop spontaneously or
is enhanced by an environment event like viral infections that alters β-cell cells,
rendering them immunogenic. Overt diabetes developed appears after most of the β-
cell cells have been destroyed.
Pathogenesis of type 2 Diabetes Mellitus
There are two main metabolic defects responsible for this type of diabetes.
One is the derangement in the β cell secretion of insulin and the other one is the
inability of peripheral tissues to respond to insulin (insulin resistance).
Epidemiological studies indicate that type-2 diabetes results from a collection of
multiple genetic defects.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Derangement in β-cell secretion of insulin
This condition is primarily due to degeneration of β-cells by numerous
mechanisms. One major reason is excess formation of uncoupling protein2 (UCP2)
inside the β-cell cell from a defective mitochondrial pathology which may be fatal to
the β-cells. Another mechanism is the deposition of Amyloid protein inside the
pancreatic islets. Amyloid is toxic to β-cells and may thus contribute to the β-cell
destruction.
a) Insulin resistance
There are three main targets of insulin action-adipose tissue, muscles,
and liver. In both pregnancy and obesity insulin sensitivity of target tissues will
decreases. These failures of utilization of insulin by peripheral tissues are called
insulin resistance. As a result the blood glucose level will be elevated. The relation
between obesity and insulin resistance has been ruled out. Recent studies indicate that
adipose tissue is not merely storage site for triglycerides, but is a versatile endocrine
tissue that can carry out a dialogue with muscle and liver both important targets of
insulin. The adipose tissue secretes 4 important secretions which are having profound
effect on insulin. They are Leptin, Resistin, tumour necrosing factor (TNF), and free
fatty acids. Increased Leptin will decrease obesity and insulin resistance where as all
the other three will promote obesity and insulin resistance. Adequate amount of
Adiponectin – a potent insulin sensitizer is the counter protein within the liver
responsible for reducing insulin resistance and increasing insulin sensitivity.
Modern classification According to etiological factors: 53
A) Type 1 Diabetes mellitus
B) Type 2 Diabetes mellitus
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
C) Other Specific types
1. Genetic defects of β-cell function
2. Genetic defects in Insulin action
D) Diseases of the exocrine pancreas
1. Pancreatitis
2. Trauma
3. Neoplasia
4. Cystic fibrosis
5. Others
E) Endocrinopathies:
F) Drug or chemical induced
1. Glucocorticoids
2. Thyroid hormone
3. Thiazides
G) Infection
1. Congenital rubella
2. Cytomegalovirus
3. Others
H) Uncommon forms of immune mediated Diabetes
I) Other genetic syndromes
1. Down syndrome
2. Klinfelter’s syndrome
3. Turner’s syndrome
4. Wolfram syndrome
5. Myotonic dystrophy
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
6. Prader – Willi syndrome
7. Friedereich’s ataxia
8. Huntington’s chorea
9. Others
J) Gestational Diabetes Mellitus
K) Others
1. Acromegaly.
2. Cushing’s syndrome.
3. Pheochromocytoma
4. Hyperthyroidism
5. Others.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
SAPEKSHA NIDANA
Acharya Charaka describes that when Madhumeha is present, sometimes it is
difficult to distinguish it from Kaphaja meha because Mutra in Madhumeha is with
Madhura taste and having Pichila Svabhava and appearance like honey. So Acharya
Charaka instructs to consider the presence of Rupa and Nidanas. If there are
symptoms of Dosha Kshaya (Kapha-Pitadi Kshaya in comparison to Vata), then it is
Vatika Prameha and if there is history of Santarpanjanya nidana, then it is
Kaphasambhava Prameha. This is important because if Madhumeha Rogi is having
less strength due to Dhatukshaya and Vatakopa is treated with Kaphamehopakramas
which will be responsible for producing adverse results.70 at the same time this can be
understood well with discretion based on the Vikara Vighata Bhava Abhava
Prativishesha principle. A protocol for differential diagnosis is given below.
TableNo.9 Differential Diagnosis
Sl
No.
Madhumeha Ikshuvalikameham21 Shitameham21
1 Vataja Kaphaja Kaphaja
2 Patients may be Krusha
or Sthula
Patients are Sthula Patients are often
Sthula
3 Symptoms of Oja kshaya No Oja kshaya No Oja kshaya
4 Incurable or Yapya Curable Curable
5 Avilamootrata Avilamootrata Avilamootrata is
absent
6 Chronic Acute Acute
7 Shareera and Mutra
Madhurya
Mutra Madhurya only Mutra Madhurya
only
From the conventional medicine point of view it is considered that all the secondary
causes for Diabetes Mellitus and also secondary causes for temporory hyperglycemic
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
state should be considered along with few recent diagnostically productive laboratory
work ups like Serum Fructosamine test and Glycosalated hemoglobin test for a better
Evidenced Based Prognostic Approach. The most important factor to be evaluated
along with these above mentioned factors is the quality of life which is highly
responsible for providing a better picture of the disease state and its prognosis with
the administered medications and lifestyle modifications32.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
UPADRAVA
The term upadrava is applied to a disease which has taken place on, produced
by the sampraptighatakas of original disease and be cured if original disease is treated
successfully.
Acharaya Charaka enumerated the general complications whereas Achraya
Sushruta and Acharya Vagbhatta described according to the Dosha predominance.
(1) General Complications54
Trishna, Atisara, Daha, Daurbalya, Arochaka, Avipaka, Putimamsa, Pidaka,
Alaji, Vidradhi etc.
(2) Specific Complications:
(a) Kaphaja meha55
Makshikopasarpanam, Alasya, Mamsopachaya, Pratishyaya, Shaithilya,
Arochaka, avipaka, Kaphapraseka, Chhardi, Nidra, Kasa and Shwasa are said to be
complications of Kaphaja meha.
(b) Pittaja meha56
Vrushanayoravadaranam, Bastibheda, Medhra toda, Hridshula, Amlika, Jwara,
Atisara, Arochaka, Vamathu, Paridhumayanam, Daha, Murchha, Pipasa, Nidranasha,
Panduroga, Pitavinmutranetratva and Vidbheda (A.H.) are said to be the complication
of pittaja meha.
(c) Vataja meha57
Hridgraha, Laulya, Anidra, Stambha, Kampa, Shula, Baddha purishatva and
shosha, kasa, shwasa are said to be the complication of vataja meha.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Complications of Madhumeha: Acharaya Charaka has mentioned 7 types of pidaka
as complication of madhumeha, while Sushruta and Vagbhatta have mentioned 10
pidakas. Sushruta has mentioned that madhumeha along with pidaka is asadhya. He
narrated that these pidaka occurs due to Tridosha and vitiated meda and mamsa.
Table No.9 Prameha Pidaka
Pidaka Charaka58 Sushruta59 Vagbhatta60
Sharavika + + +
Kacchhapika + + +
Jalini + + +
Sarshapi + + +
Alaji + + +
Vinata + + +
Vidradhi + + +
Putrini - + +
Masurika - + +
Vidarika - + +
COMPLICATIONS OF DIABETES MELLITUS61
Complications of Diabetes mellitus fall into two major divisions i.e. Acute
Complications and Chronic Complications. The complications resulting from the
disease are associated with the damage or failure of various organs such as the eyes,
kidneys and nerves.
Acute Complications
Diabetic Ketoacidosis and Non Ketoic hyperosmolar state are the acute
complication.
Chronic Complications:
(1) Macrovascular Complications:
Coronary artery disease.
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Peripheral Vascular disease.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Cerebro vascular disease.
(2) Microvascualar Complications:
• Diabetic Eye disease
Retinopathy (non-proliferative/proliferative)
Macular edema
Glaucoma
Cataracts
• Diabetic Neuropathy
Poly neuropathy /mono neuropathy
Autonomic neuropathy.
(3) Other
Gastro intestinal [gastroparesis, diarrhoea]
Genito urinary [uropathy /sexual dysfunction]
Dermatologic infections.
Diabetic foot.
(A) Acute Complications:
Diabetic Ketoacidosis [DKA]:
Ketoacidosis is one of the most serious metabolic complications of diabetes,
even if managed properly. It can be developed for individuals with type1 DM.The
prognosis substantially worsened at the extremes of age and in the presence of coma
and hypotension.
Clinical Features:
Nausea, vomiting, thirst, polyuria, abdominal pain, altered mental function are
the clinical features of DKA.
Physical Findings:
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Tachycardia, Dry mucous membranes, reduced skin turgor, Dehydration,
hypotension, Tachypnea, Kussmaul respirations, respiratory distress, abdominal
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
tenderness, Fever, Lethargy, Obtundation, Cerebral edema and possibly coma are the
physical findings of DKA.
Precipitating Factors:
Infection, Cerebrovascular Accident, Myocardial infarction, Alcohol abuse
and discontinuation of or inadequate insulin is the main precipitating factors for DKA.
Treatment:
Correction of dehydration, hyperglycemia and electrolyte imbalances is the
treatment modalities for DKA. Identification of precipitating factor and frequent
patient monitoring are also important.
Non Ketoic Hyperosmolar State [NKHS]:
Clincial Features:
Polyuria, Orthostatic hypotension, Lethargy, Altered mental status,
Obtundation, Seizure and Coma is the clinical features of NKHS.
Physical Findings:
Dehydration, Hyperosmolality, Hypotension, Tachycardia and Altered mental
status are the main physical findings of NKHS.
Precipitating Factors:
Concurrent illness such as myocardial infarciton, stroke, sepsis, pneumonia,
debilitating conditions like dementia are found to be the main precipitating factors for
NKHS.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Treatment:
Correction of dehydration, Insulin administration and Frequent Patient
Monitoring are the treatment modalities.
(B) Chronic Complications:
Chart No. 3 - Mechanism of developing chronic complications62
Hyperglycaemia
Activation of protein kinase C
Formation of advanced glycation end products (AGE)
Activation of polyol pathway
Endothelial nitric oxide synthase uncoupling
Activation of protein kinase C
Activation of reactive oxygenease
Induction of DNA damage
Reduction of nitric oxide bioavailability
Altered gene expression
Increased AGE formation
Induction of oxidative stress
The possible mechanism of complication is yet to be elucidated.
Three theories have been proposed for the mechanism of complications.
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One hypothesis proposes that increased intracellular glucose leads to inceased
sorbitol wich aris a polyol. Some glucose converts into sorbitol by aldose reductase.
Increased sorbitol concentrations leading to cellular dysfunction will exhibits the
complication of Diabetes Mellitus.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Second hypothesis suggests that increased intra cellular glucose levels leads to
the formation of Advanced Glycosylation End products (AGEs). AGEs modulate
atherosclerosis, accelerate glomerular dysfunction, decrease nitric oxide synthesis,
and promote endothelial dysfunction which leads to complication by altered cell
function.
Third hypothesis has been explained in following manner. Increased
hyperglycemia increases the formation of diacylglycerol which activates certain
isoforms of protein kinase C, which leads to complications through altered gene
expression or growth factors.Increased level of growth factors such as, Platelet
derived growth factor, epidermal growth factor & vascular endothelial growth factor
leads to complication of Diabetes mellitus.
Glycemic control and Complications:
The DCCT (Diabetes Control and complications Trial) results postulated that
improvement of glycemic control reduced nonproliferative and proliferative
retinopathy, micro albuminuria, clinical nephropathy and neuropathy. The United
Kingdom Prospective Diabetes study results establish that retinopathy, nephropathy
and neuropathy are benefited by lowering blood glucose levels in type 2 diabetes with
intensive therapy. The overall complication rate was decreased by 60% with intence
therapy and strict glyceamic control.in patients with type1 diabetes strict glyceamic
control achieved a substancially lower HbA1c (7.2%) than individuals in the
conventional diabetes management group (HbA1c of 9%).
(1) Diabetic Retinopathy:
Diabetic Retinopathy is a most frequent cause of blindness among adults aged
20-74 yrs. Diabetic retinopathy is classified in to two stages proliferative and non
proliferative.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Nonproliferative diabetic retinopathy usually appears late in the first decade or
early in the second decade of the disease and is marked by retinal vascular
microaneurisms, blot heamorrhages and cottonwool spots.
The appearance of neovascularisation in response to retinal hypoxia is the
hallmark of proliferative Diabetic retinopathy.they rupture easily and leading to vitrial
hemorrhage, fibrosis and ultimately retinal detachment.
(2) Diabetic Neuropathy63:
Diabetic neuropathy occurs in approximately 50% of individuals with
continuum of hyperglycemia in type 1 and type 2 diabetes mellitus. It may manifest as
polyneuropathy, mononeuropathy and autonomic neuropathy.
Polyneuropathy
Manifestations:
Distal sensory loss, Hyperesthesia, Paresthesia, Pain [usually in lower extremities]
Physical findings:
Sensory loss, Loss of ankle reflexes, Abnormal position sense, Parethesia
[sensation of numbness, tingling, sharpness or burning]
Diabetic polyradiculopathy is a syndrome characterized by severe disabling
pain in the distribution of one or more nerve roots.
Mono neuropathy:
It presents with pain and motor weakness in the distribution of a single nerve.
Involvement of the third cranial nerve is most common.
Physical findings:
Ptosis, Opthalmoplegia with normal papillary constriction to light can be
noted.
Peripheral mononeuropathies or simultaneous involvement of more than one
nerve (Mononeuropathy multiplex) may also occur.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Autonomic neuropathy:
Individuals with long standing type- 1 or type- 2 Diabetes may develop
autonomic neuropathy involving multiple systems, like the cardiovascular system,
genitourinary system, gastro intestmal tract, psudo motor system and metabolic
systems.
As a result of sympathetic nervous system dysfunction hyperhidrosis of the
upper extremities and anhidrosois of lower extremities occurs which promote dry skin
with cracking. Autonomic neuropathy may reduce counter regulatory hormone
release, leading to an inability to sense hypoglycemia.
3. Diabetic nephropathy:
Diabetic nephropathy is an important cause for morbidity and mortality,and is
now among the most common causes of end-stage renal failure(ESRF)in developing
countries. As it is found with other microvascular and macrovascular complications,
management is frequently difficult and the benefits of prevention is substantial.About
30% of patients with type1 diabetes have developed diabetic neuropathy after 20
years and epidemiological data suggested that the over all incidents is declining as
standards of glyceamic control increased.microalbuminuria is an important indicator
of risk developing nephropathy and more reliable for type1 diabetes than type2
variety.risk factors for developing diabetic nephropathy includes poor control of
blood glucose,long duration of diabetes,presense of other microvascular
complications,familyhistory etc.
(4) Cardio vascular disease64
Cardiovascular disease is the leading cause of mortality for with diabetes.
Type 2 diabetes is an Independent risk factor for macrovascular disease and its
common coexisting conditions i.e. hypertension & dyslipidemia.
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Hypertension (blood pressure > 140/90 mmHg) is a common comorbidity of
diabetes, affecting 20-60% of people with diabetes, depending on age, obesity and
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
ethnicity. Lowering of blood pressure with regimens based on antihypertensive drugs,
including ACE inhibitors, angiotensin receptor blockers (ARBs), B-blockers, diuretics
& calcium channel blockers has been shown to be effective in lowering cardio
vascular events.
Patients with type 2 diabetes have an increased prevalence of lipid
abnormalities. Which account for higher rates of CVD. The most common pattern of
dyslipidemia in type 2 diabetic patients is elevated triglyceride levels. Type 2 diabetic
patients typically have a preponderance of smaller, denser LDL particles, which
possibly increases atherogenicity even if the absolute concentration of LDL is not
significantly increased.
Table No. 10. Abnormal Lipoprotein levels in adults with Diabetes Mellitus.
LDL Cholesterol HDL Cholesterol Triglyceude
> 130 <40 > 400
(5) Gastrointestinal Dysfunctions:65
Symptoms:
Delayed Gastric Emptying [gastropresis], Altered small & large bowel
Motility [Constipation or diarrhoea], Anorexia, Nausea, Vomiting, Early satiety,
Abdominal bloating.
(6) Genito urinary Dysfunction:
• Cystopathy
• Erectile dysfunction
• Female sexual dysfunction
• Dyspareunia
• Vaginal Lubrication
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
(7) Diabetic Foot: 66
Foot ulcers and amputations are a major cause for individuals with diabetes.
The risks of ulcers or amputation increased in people who have had diabetes > 10
years have poor glucose control have renal, retinal or cardio vascular complications.
Clinical features include neuropathy and ischemia which presents with
parasthesiae, pain, numbness, claudication, ulcer, gangrene, Osteoomyelitis etc.
Table No.11 Complications of Diabetes according to modern and ayurvedic.
MODERNVIEW AYURVEDIC VIEW
Carbuncles Pidakas
Diabetic gangrene Poothimamsatha
Gastrointestinal disfunction Pipasa,arochaka,avipakaAtisara
Lethargy Dourbalya
Genital dysfunction Vrushanayoravadaranam
Nephropathy,Retinopathy
Neuropathy
Saithilyam (Netra, Muthravahasrothas,
Nadisamsthanam).
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
ARISHTA LAKSHANA
The following two features are mentioned by Acharya Charaka as arishta
lakshana i.e.the signs of incurability or indication of ensured death which are highly
liable for physician’s cognitive discretion.
1. According to Acharya Charaka, the person in whose body, the flies are attracted
after bath also is sure to die due to Prameha. 68
The sweetness of body is in large proportion in prameha and after bath also the
skin remains sweet. Extensive hyperglycemia may produce diabetic coma and patient
may die.
2. Acharya Charaka also says that the person who drinks various kinds of oils and
ghees or other unctuous preparations with Chandala in his dreams may die of prameha
in future.69
This shows the relationship between altered bodily functions in Madhumeha
and its impact in the mental status. Unctuous preparations like oils and ghees are the
representatives of soumya dathus. Here chandala represents the altered status of
soumya dhathu’s like Vasa, Majja, Ojas, Meda, Kleda etc.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
DIAGNOSIS OF DIABETES MELLITUS71
It is the early diagnosis of Diabetes Mellitus which is finding more importance
in the Healthcare domain than mere diagnosis, which is also of great important
because it helps in two perspectives regarding the management of the disease.
1. Firstly, it helps in defining the threshold for various interventional strategies
aiming to control symptoms and ameliorate development of short term and long
term complications.
2. Secondly, it helps in epidemiological studies to estimates its prevalence and
incidence along with the risk factors which inturn helps to strategise the
preventive and therapeutic measures.
Amidst the various technological advances in medicative therapy it is the early
diagnosis which has still remained as an enigmatic topic of discussion in any stream
of medicine. Good news for the Ayurvedic physicians is that they have the emeritus
tool for discreting the condition for early diagnosis of this dreadly creeping disease.
Diagnostic Criteria
Currently accepted diagnostic criteria across the world are those proposed by
the expert committee of American Diabetic Association in 1997 and accepted by
WHO in 2009. The same criterion used by DCCT for its clinical studies on diabetes
mellitus has been used for the present study.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
TableNo.12. WHO approved Diagnosis Criteria for Diabetes Mellitus
WHO approved Diagnostic Criteria of Diabetis Mellitus
Venous plasma Capillary blood
Fasting ≥126mg/dl >110mg/dl
2 hrs post glucose ≥200mg/dl >200mg/dl
Random blood glucose ≥200mg/dl
In a patient who is having cardinal symptomatology of diabetes mellitus
(Polyphagia, Polyuria, Polydypsia Unexplained Weight Loss, Drowsiness or Coma),
Fasting Plasma Glucose Level ≥126mg/dl or 2hrs post 75 gm glucose level ≥
200mg/dl is considered as the Diagnostic Criteria for Diabetes Mellitus. Fasting
plasma glucose level (FPG) less than 100mg/dl is considered as normal. However
FPG level of 101-125mg/dl is considered as IFG (Impaired Fasting Glucose) and is
refered to pre-diabetic condition.
TableNo.13 Impaired Fasting Glucose Level
Impaired Fasting Glucose
Venous plasma Capillary whole
blood
Fasting 100-125 mg/dl NA
2 hrs post glucose ≤140 mg/dl ≤140 mg/dl
If performed ≤200mg/dl ≤200 mg/dl
Oral Glucose Tolerance Test (OGTT)
In asymptomatic individuals, individuals with IFG and those with Random
Plasma Glucose level between 100-200mg/dl an OGTT is strongly recommended for
diagnosis.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Precautions
1. It should be done in the morning after unrestricted carbohydrate diet and
usual physical activity for previous 72 hrs.
2. The subject should be fasting for atleast 10 -16 hours before the test (may
drink water).
3. The subject should not be smoking during the test.
4. Any concomitant medication, infection or inactivity must be recorded and
be taken into consideration while interpritting the results.
Procedure:
The test should be performed with 75g of anhydrous glucose in 150 – 300 ml
of water over the course of 5 mins. Children should be given 1.75gm/kg of body
weight, upto a total of 75g glucose. Blood should be collected in a tube containing
sodium fluoride (6mg/ml of whole blood) and centrifuged properly to separate out the
plasma. Two hours post glucose value of more than 200mg/ dl is considered
diagnostic for diabetes, while values ranging between 140-200 mg/dl are considered
Impaired Glucose Tolerance (IGT).
TableNo.14. Impaired Glucose Tolerance Test
Impaired Glucose Tolerance
Time Venous Plasma Capillary whole blood
Fasting(if measured) < 126 Mg/dl or < 7
mmol/L
< 110 Mg/dl or< 6.1 mmol/L
2 hours post glucose 140- 199Mg/dl or 7.8- 11.0
mmol/L
140- 199Mg/dl or 7.8- 11.0
mmol/L
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Glycosylated or Glycated Heamoglobin – HbA1C123
In normal individuals a small proportion of heamoglobin combines with the
circulating blood glucose and this fraction is called glycosylated or glycated Hb. This
can be separated in to 3 types HbA1a, HbA1b, and HbA1c. More binding is to HbA1c.
The binding of glucose to Hb is a non-enzymatic process that occurs
continuously through out the lifespan of the RBC. Once glycated the elevated levels
persists till the red cell dies.
The amount of glycated Hb reflects the efficacy of glycemic control in a
diabetic patient during the 8-12 week period before the blood was collected. Normal
level of HbA1C is below 7%. Elevation of HbA1C above this value is evidence of a
condition which is in need of glycemic control during the preceding 8-12 weeks. It
reflects the radical changes in diet or modes of therapy approximately 3-4 weeks after
the initiation of the change. HbA1C is now considered as the most important
diagnostic criteria which help in detecting an unknown hyperglycemic episode within
a span of 2 yrs and the goal of the any treatment in type-2 diabetes being achieving
the HbA1C level <7% along with Fasting and Post Prandial Blood Sugar Level
between 90-130 mg/dl and below 180 mg/dl respectively.
Commonly used techniques for its measurement are chromatographic and
thiobarbitone calorimetric method. It is wise enough to keep in mind that the inter
laboratory variations are high due to lack of standardization. There are few factors
which influence falsely elevated levels of HbA1C and they are,
1. Fructose rich diet.
2. Hyperlipedemia.
3. Uremia.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
4. Elevated temperature and elevated pH of the blood.
There are few factors which influence false low values like,
1. Pregnancy.
2. Anemia.
3. Post blood transfusion period.
4. Low temperature and low pH of the blood.
Advantages:
1. It is useful for assessing long term blood sugar control.
2. The levels of the blood glucose can be easily manipulated by the patients by
taking extra dose of the OHA or insulin or even missing meals on the day of
test so that patient can get good results but HbA1C is unaffected by time, type
of blood sample either venous or capillary, even fed or fasting state.
Disadvantages:
1. It cannot help in diagnosing hypoglycemic episodes or even diabetic
ketoacidosis.
2. It is sometimes possible to obtain normal values in patients suffering from
frequent and dangerous episodes of hypoglycemia, if these are balanced by
other episodes of excessive hyperglycemia.
3. It is highly dependent on the life span of the RBC.
4. If it is measured by electrophoretic method and patient who drink 30 or more
units of ethanol per week then the values may be higher due to the
acetaldehyde derived from the ethanol binds non enzymatically to side chain
of Hb which moves in same direction. This is ovecomed through
electroendosmosis method.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
5. It is not useful for day-to-day management and in adjusting the dose of insulin
or oral anti diabetic drugs.
RELATION TO THE DIABETIC COMPLICATIONS:
The process of glycation is highly indicative of susuceptibility for short term
and long term Microvascular and Macrovascular complications as well as various
neural dysfunctions. Thus it is also indicative of the extent and rate of progression of
retinopathy and neuropathy although the genetic determinants of tissue susceptibility
and independent triggering factors like HTN can also influence the clinical course in a
varied degree of manifestation.
PROPHYLACTIC MEASURES FOR GLYCATION:
Based on recent studies it is now known to the conventional stream about the merit
and demerits of thiamine pyrophosphate and aminoguanide with its analogues as the
prophylactic measures in inhibiting the rate of formation of AGEs but, since it has its
root in the rate and extent of immunoresponsive tissue response and its respective end
products with its timely elimination from the system which is still an enigmatic topic
for its clinical execution from the conventional stream due to its limited extent of anti-
oxidant therapy.
DETECTION OF URINE SUGAR72
The time honoured test for qualitative detection is by boiling urine with copper
containing fehling’s reagent or benedict’s reagentwhich is reduced by glucose and the
blue colour is changed to yellow through red depending upon the amount of
glucose.Eight drops of urine(0.5ml) are added to5mL of benedict’s reagent and boiled
for 2 minutes,cooled and colour is noticed.Sugars reduce the copper and produce
colours ranging from green to brick red,depending upon their concentration.this
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
colour is compared to the colour of the reagent before heating.this test is nonspecific
since several sugars like fructose, lactose, galactose, aspirin, VitC and many drugs
may give a positive result.
Specific test for glucose is the glucoseoxidate test,test papers beingavailable
commercially,based on specific enzyme mediated reactions which can also be
quantitated.Test strips are unaffected by the other sugars or drugs.
CLINICAL SIGNIFICANCE:
The high blood glucose causes more glucose to filter into the renal tubules
than can be reabsorbed, and the excess glucose spills into the urine.This normally
occurs when the blood glucose concentration rises above 180 mg/100 ml, a level that
is called the blood “threshold” for the appearance of glucose in the urine.When the
blood glucose level rises to 300 to 500 mg/100 ml—common values in people with
severe untreated diabetes—100 or more grams of glucose can be lost into the urine
each day.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
SADHYASADHYATA
Prognosis forms the Culminative part of Chikitsa so far as a wise physician
and his discrete plans of treatment are concerned. Success of the treatment depends on
an unbiased prognosis; but in this condition in the present era, it is liable for discretion
based on Vikara Vighata Bhava Abhava Prativishesha. Generally the concept of
prognosis in the case of Madhumeha is given by all acharyas as Kaphaja Madhumeha-
Sadhya, Pittaja Madhumeha-Yapya and Vataja Madhumeha-Asadhya, when occurred
due to Dhatukshaya and Krichrasadhya when the whole pathology underlying is well
established due to avarana.
Prognosis of Kaphaja Madhumeha
Charakacharya illustrated the prognosis of this disease by considering the
presence or absence of poorvarupas. Kaphaja meha with poorvarupas are considered
Krichrasadhya while the one associated with pittaja meha is described as
Pratyakhyeya. Acharya Chakrapani opines that, appearance of poorvarupa in the latter
is a cardinal sign of incurability; which, as a general rule can be applied to any disease
but with discretion. Here in the context of Madhumeha, the presence of all or few
poorvarupas like Visrasharirgandham can be considered as asadhyatva.
The second concept of prognosis is connected with medodushti .If the
medodushti is to a lesser extent, then the disease can be easily cured.So it is important
to consider the gradation of poorvarupas as well as the extent of medodushti for
having a concept of prognosis in meha. Keeping the above concepts in mind, the
sadhyasadhyata can be derived as Kaphaja meha is Sadhya, Kaphaja meha associated
with few poorvarupas is Krichrasadhya, Kaphaja meha having all the poorvarupas is
Asadhya, Kaphaja meha with severe medodushti is Asadhya, Kaphaja meha with both
profound medodushti & poorvarupas is Asadhya, Kaphaja meha & associated
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
congenital factors is Asadhya and Kaphaja meha with few poorvarupas but with
severe medodushti is Asadhya.
Prognosis of Pithaja and Vathaja Madhumeha
Pitaja Madhumeha is considered as yapya, while Vataja madhumeha are
having the status of Asadhyatva. This is the result of the nature of disease and
associated dhatus.Kaphaja meha can be treated with katu, tikta& kashaya rasas, then
both the kapha dosha and the associated Samadhatus can also be treated with the same
treatment at the same time. In case of Pittaja Madhumeha and Vataja Madhumeha, the
disease and associated vitiated dhatus are having opposite qualities. So yapyatva &
asadhyatva arises respectively.
Pitaja Madhumeha is explained to be with this status.The disease requires
continuous treatment. Once the treatment is stopped the disease is again provoked.
Also Vishamakriyatvat i.e. the doshas are conquered by Langhana Therapy but the
associated vitiated dhatus suffer simultaneously. This also leads to yapyatva.
Prognosis of Madhumeha
Madhumeha in terms of specific type and asadhyata is one among the Vataja
Prameha explained. Here vata provocation might be due to sarvadhatukshaya as it
occurs after kaphaja & pittaja Madhumehas. Another important cause is Avarana.
When vata provocation is due to dhatukshaya the type is included in asadhya
Madhumeha, while the other produced by avaranjanaya vata is considered as
Krichrasadhya. Charakacharya mentioned that Madhumeha produced due to
beejadosha is incurable.
Considering all possibilities the prognosis of the disease Madhumeha can be
summarized as follows.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
MODERN PERSPECTIVE ON PROGNOSIS:
Diabetes is not a curable disease; the treatment Strategy is to enable patients to
lead lives Similar to those of healthy persons, while preventing complications
through appropriate timely Treatment and Personal Management. To achieve this
objective, it is important to reduce Psychological, Physical, and Lifestyle Burdens and
restrictions due to diabetes as much as possible. So, evaluation of health-related
quality of life (HRQL) is of more important for evaluating the burden on patients and
in selecting appropriate therapeutic method. Health Related Quality of Life
measurement provides a Comprehensive evaluation of the patient’s health status
which would provide additional Information to laboratory data and also with the
subjective symptoms which in turn Indicates the Importance of Dinacharya and
Rutucharya for both healthy and unhealthy Individuals.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
CHIKITSA
The principles of the therapeutic measure form the core part of the strategies
for the proper management of the disease especially if Madhumeha is taken into
consideration because of peculiar vyadhi swabhava and Atura. The samprapti should
be considered deeply before stepping into the management.
CHIKITSA SUTRA:
The eminent ancient ayurvedists, Charaka, Sushruta and Vagbhata are
considering the body constitution and strength of the body of the patient when dealing
with the management aspect.Charakacharya considers two types of patients, one is
that with stout body structure and with strength and the other without strength and
krisha. Sushrutacharya also says that sahaja meha rogi will be krisha and
apathyanimittaja rogi will be sthula.73
In the context of medoroga, the managements described are parallel to that of
meha since the dosha and dushyas are same to major extent. After considering all the
factors the two types of management emphasised are:
(1) Samshodhana Chikitsa: [Elimination Therapy]
(2) Samshaman Chikitsa: [Normalizing Therapy]
Like every disease, those factors which are responsible for the production of
the diseases are if eliminated and if further, causative factors are prevented meha can
also be treated. Madhumeha can be treated in this way although it is described as
incurable. In Pratyakhyeya vyadhis, symptomatic relief can be given by proper
management.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
KAPHAJA PRAMEHA:
(i) Samshodana Chikitsa:
It is better to treat the patient with vaman therapy. Charakacharya describes
that shodhana, vamana and langhana done at the proper time looking at the condition
of the patient is able to cure kaphaja meha. 74
For Bastichikitsa Vagbhata describes the utilization of Surasadi gana kwatha.
Acharyas after explaining the shodhana treatment give samshaman Chikitsa in every
type.
(ii) Samshamana Chikitsa:
Charakacharya gives 10 combinations of drugs to all the mehas with kapha
predominance. 75
According to Sushruta, after proper samshodhana the patient should use
swarasa of amalaki with Haridra powder with madhu.76
Acharya Sushruta in this context explains single drug decoctions with separate
indications in 5 types of kaphaja meha and combinations in other 5 types.77
Vagbhatacharya describe three yogas in this aspect. They are as follows
Lodhradi- Lodhra, Abhaya, Musta, Katphala
Pathadi - Patha, Vidanga, Arjuna, Dhanyaka
Gayatrayadi - Khadirsara, Darvi, Vidanga, Vacha 78
Importance of Apatarpana:
Charakacharya explains the cause of prameha as due to increasing attitude of
kleda, meda and kapha. So he emphasise the role of Apatarpana in kaphaja and
Pittajaprameha79.
Different types of vyayama, kshut, udvartana, dhara and snana with churnas
made of Chandana, Aguru, and Ela etc. are advised to use in kaphaja meha.80
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
PITAJA PRAMEHA:
(i) Samshodhan Chikitsa:
Virechan is best in pittaja pramehas. The drugs which are sufficient to
eliminate morbid pitta can be used with sheeta and other tikta, kashaya rasa in this.
Nyagrodhadi gana kwatha is advised for Asthapanbasti by Acharya
Vagbhata.Acharya Sushruta has described that due to spreading of medo dhatu all
over the body, Madhumehi subjects are durvirechya.81
(ii) Samshaman Chikitsa:
Acharya Charaka explains 10 pada yogas in this aspect to treat pittaja pramehas.
Sushrutacharya has described 6 specific kwatha yogas for the specific type of pittaja
prameha. 82
The three kwatha yogas explained by Acharya Vagbhatta are,
Ushiradi: Ushira, Lodhra, Arjuna, Chandana.
Patoladi: Patola, Nimba, Amalaki, Amrita
Lodhradi: Lodhra, Ambu, Kaleyaka, Dhataki83
VATAJA PRAMEHA:
Although vatika mehas are incurable still Acharya Charaka explains to induce
certain treatment in kaphapittanubandhi Vatika meha84.
Achrya Sushruta has described that all types of prameha if not treated properly
in time, gets converted into Madhumeha.85 So the treatment described for vatika meha
can be considered as treatment of Madhumeha.
MADHUMEHA:
(i) Samshodhana Chikitsa: 86
Considering Sthula and krisha pramehi, Samshodhana Chikitsa should be
administered only to the Sthula and Balvan Pramehi86. Sarshapa, Nimba, Danti,
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Vibitaki and Karanja siddha Taila or Trikantakadya Sneha (Ghrita or Taila) according
to dosha predominance should be used for Abhyantara Snehana. Here while
explaining the Samshodhana, Charaka describes to use the Malashodhan yogas from
Kalpasthana. Both Pitta and kapha are eliminated through shodhana. It may be
vamana or virechana, because of; Pittantam Vamanam, Kaphantam Virechanam. In
Virechana pitta is eliminated first, then Samyak lakshana of virechana is
kaphadarshan, so both pitta and kapha doshas which are vitiated are eliminated. Then
the described Anuvasana and Asthapana Basti chikitsas are able enough to control the
provocation of vata. Like this all the doshas are normalized to keep the dosha
samyata. Anuvasana with medicated oils and ghritas are prescribed in Madhumeha.
After proper Shodhan Chikitsa, Charakacharya details to give santarpan chikitsa to the
patients, to prevent the complications like Gulma, Bastishula etc.
(ii) Samshamana Chikitsa:
Samshamana Chikitsa includes mainly deepana (appetizers) , Pachana,
(enhancing digestion), Kshut (Hunger maintenance), Trit (Maintenance of thirst),
Vyayama (Exercise), Atapa (Having exposed to sunlight ) and Maruta ( Exposing
oneself to wind).According to the conditions of vitiated doshas & dushyas , vaidya
has to suggest proper Shaman Chikitsa to the patient.
Acharyas introduces different tarpana upakramas in vatika mehas. It is due to
the less strength of the patient. Acharya Charaka and Vagbhatta says that the kashaya
yogas should be enriched with sneha and given to vatika mehas.
Typical Madhumeha Chikitsa: 87
Acharya Sushruta explains that Shilajit should be taken after triturating with
Salsaradi gana kwatha. After its digestion patient should take Jangalamamsarasayukta
Anna. He prescribes to take 1 Tula of shilajatu.
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Swarasa: Amalaki, Haridra, Nimbapatra, Bilwapatra, Guduchi
Kwatha: Vidangadi, Phalatrikadi, Mustadi, Manjishthadi, Pathadi
Churna: Triphaladi, Mustadi, Gokshuradi, Arkadi
Gutika: Chandraprabha, Indravati, Pramehantak Vati
Gugglu: Gokshuradi Guggul
Modaka: Kastur Modaka
Avleha: Kushavleha, Bangavleha
Paka: Pugapaka, Ashwagandhadi paka, Draksha Paka.
Asava Arishta: Lodhrasava, Dantyasava, Madhukasava, Devdarvyadiarishta,
Lodhrarishta.
Ghrita: Dhanvantar ghrita, Trikantakadi ghrita, Sinhamrita ghrita, Dadimadi ghrita,
Shalmali ghrita.
Rasaushadhi:Vasant kusumakar Rasa, Mehamudgar Rasa, Brihat Bangeshwar Rasa,
Prameha gajkesri Rasa, Tribanga Bhasma, Vasant tilaka Rasa.
TREATMENT OF DIABETES MELLITUS88
Goals of treatment of diabetes:
Diabetes mellitus requires ongoing medical care as well as patient and family
education both to prevent acute illness and to reduce the risk of long term
complications. The management of diabetes patient is not aimed solely at glycemic
control to restore known metabolic derangements towards normal in order to prevent
and delay progression of diabetic complications. The aims of treatment have been
varied according to an arbitrary division of patients into three categories ranging from
those in whom symptomatic relief done seems the most appropriate or any attainable
goal to those in whom an attempt at maximal prophylaxis against future tissue
damage seems desirable and possible.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Oral Drugs for Treating Hyperglycemia: 89 Oral drugs are used to lower Blood
glucose level by achieving following goals.
1. Drugs that primarily stimulate insulin secretion
2. Drugs that alter insulin action.
3. Drugs that principally affect absorption of glucose.
Mainly used drugs are Sulphonylureas and Biguanides.
Sulphonylureas: These drugs stimulate production of Insulin initially but later on
they act by their extra pancreatic actions. These include reduced hepatic release of
glucose and improved sensitivity to Insulin, possibly due to an increase in number of
peripheral Insulin receptors. Sulphonylureas are mainly indicated for Maturity onset
Diabetics of average weight not controlled by diet alone. The contraindication
includes juvenile Diabetes, Ketosis, patients taking Insulin and presence of renal,
hepatic, cardiovascular disease or alcoholic abuse. Hypoglycemia, dyspepsia, skin
rashes, facial flushing after ingestion of alcohol are the most frequently encountered
side effects with sulphonylureas. E.g. Tulbutamide, Chlorpropamide etc.
Biguanides: There major effect is to increase the peripheral uptake of glucose and in
large doses to delay or decrease intestinal absorption. These are the drug of choice for
the treatment of maturity onset obese diabetic patients who have failed to lose weight
on diet. Biguanides are also used in combination with sulphonylureas to enhance the
inadequate or failing effects of the latter. But these affect the gastrointestinal tract
adversely and the incidences of death from lactic acidosis are substantially high. The
adverse effects include metallic taste in mouth, anorexia, nausea, dyspepsia, diarrhea,
malaise, weakness, drowsiness, lactic acidosis and lastly the vitamin B12
malabsorption after prolonged treatment. E.g. Phenformin, Metformin, etc
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
ORAL HYPOGLYCEMIC AGENTS:
TableNo.16 Oral Hypoglycemic Agents Drug Action
Agent Mechanism of
Action
Example Anticipated
Reduction
in HbA1C%
Agent Specific
Advantages
Insulin
Secretagogues
Sulfonylureas
Insulin
Glipizide
1-2
Lower fasting
blood glucose
Meglitinide
Repaglinide Short onset of
action,lower PPBG
Biguanides Hepatic glucose
production, ,
glucose utilization
Metformin
1-2
Weight loss,
Improve lipid
profile, No
hypoglycemca
Alpha-
Glucosidase
inhibitors
Delay Glucose
absorption in the Gut
Acarbose
miglitol
0.5-1 No risk of
hypoglycemia
Thizolidinedio
nes
Insulin resistance Rosiglitazone
Proglitazone
1-2 Insulin &
Sulfonylurea
requirements,
triglycerides.
Insulin:
Insulin is indicated for type - I diabetic as well as for type - II diabetic patients with
insulinopenia whose hyperglycemia does not respond to diet therapy either alone or
combined with oral hypoglycemic drugs. Insulin injections are very much necessary
in severs conditions of hyperglycemia. There are various preparation are present
depending upon their purity, solubility and species (like Human/Bovine).
Type of Insulin: Apart from the species difference, seven types of Insulin are
commercially available. They may be divided into Insulin of fast, intermediate and
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
long action (Harrison, 1981). They may also be called Soluble Insulin, Protamine
Insulin and Insulin zinc suspension. Highly purified, semi-synthetic human Insulin
offers a safe and effective means to explore the possible advantages of homologous
human Insulin in the management of Diabetes mellitus.
Choice of Insulin: Crystalline Insulin is best for emergencies such as for the
treatment of Diabetic Ketoacidosis. It is also employed for daily use in combination
with intermediate Insulin to bring on earlier action.
Treatment of Chronic Complications:
Multidisciplinary approach is recommended for persons with complications of
diabetes.
To reduce the risk and slow down the progression of nephropathy, glucose control and
blood pressure control should be optimized along with Specific treatment of the
complications such as laser photocoagulation in diabetic retinopathy etc..
Steps in the management of Diabetic Patients:
Diagnostic Examination: All necessary investigations should be done for the
diagnosis including all systemic examinations along with proper history.
Patient Education (Self Management Training): Since diabetes is a life long
disorder, education of the patient and family members is probably the most important
obligation of the physician.
ADVICE:
Check Regular Blood Glucose Level: Self monitoring of blood glucose may be
advice to the patients as it has provided greater flexibility in management while
achieving improved glycemic control.
Diet Control Therapy: Treatment must be individualized on the basis of type of
Diabetes and specific needs of each patient.
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Both modern medicine and ayurveda emphasize the importance of regulation of high
calorie diet and observation of probable mode of exercises.
PATHYA-APATHYA90
Those Aaharas and viharas which are suitable to the disease condition are
called Pathya and those which promote severity of disease are called Apathya. Pathya
is having a key role in the management of Madhumeha. Even in modern science also
Diet & Exercise are included in diabetes management. So before stepping to
management we have to consider for the Pathya-Apathya. Pathya and Apathya Aharas
and Viharas according to different Ayurvedic classics are as follows:
Pathya: 91
(a) Aahara:
Shook Dhanya: Jeerna Shali, Shashtika, Kodrava, Yava, Godhuma, Uddalaka,
Shyamaka
Shimbi Dhanya: Chanaka, Adhaki, Kulattha, Mudga
Shaka Varga: The leafy vegetables with a predominance of tikta-kashaya rasa,
Patola, Karvellaka, Shigru
Phala Varga: Jambu, Dadima, Shringataka, Amalaki, Kapittha, Tinduka, Kharjura,
Kalinga, Navina Mocha.
Mamsa Varga: Vishkira mamsa, Pratuda, Jangala mamsa
Taila Varga: Danti, Ingudi, Sarshapa, Atasi
Udaka Varga: Sarodaka, Kushodaka, Madhudaka
Kritanna Varga: Apupa, Saktu, Yavodana, Vatya, Yusha
Others: Madhu, Hingu, Saindhava, Maricha, Lasuna
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(b) Vihara:
To have walks, travelling on elephants, horses and different plays, different
form of marshal arts, roaming in different places without chappal and umbrella.
Apathya: 92
(a) Ahara: Jala, Milk, Ghee, Oils, Curd, Sugar, Different types of rice preparations,
anupa, gramya and audaka mamsa, Ikshurasa, Pishtanna, Navannan, sauveraka,
suramadya, suktha, Amlarasaahara, sugarcandy juice,.
(b) Vihara: Eksthana asana, Divaswapa, Dhoompana, Sweda, Raktamoksha,
Mutravega dharana.
TREATMENT REGIMENS: MODERN VIEWS.
Diet:
A well-balanced nutritious diet remains a fundamental element of therapy. In
obese patient with mild hyperglycemia the major goal of diet therapy is weight
reduction by caloric restriction. Dietary treatment of Diabetes still constitutes the
basis for management, so that it is believed even today that 50% of diabetics could be
put to control only by judicious dietary regimen. The chief aims of diabetic diet are: 93
a) Achieve good glyceamic control
b) Reduce hyperglyceamia and avoid hypoglyceamiaPrevent hypoglycemia
c) Obtain ideal body weight.
d) Reduce the risk of micro and macrovascular complications.
e) Ensure adequate dietary intake.
Type of Diet: Basically there are two types of diet:
Unmeasured Diets: If Insulin or oral hypoglycemic agents are not required and
marked obesity is not present it may not be necessary for the patient to follow such an
accurate diet.
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Forbidden Foods: Sugar, Jam, Honey, Tinned fruits, Sweets, Chocolates, Glucose
Drinks, Food made with Sugar, Cakes, Sweet Biscuits, Puddings, Rice and alcoholic
drinks.
Foods allowed in moderation: Chapatis made from wheat or millets, peas and backed
beans, breakfast cereals and all fresh and dried fruits, custard.
Free Foods: Eggs (not fried), vegetables such as cabbage, cauliflower, brinjal, lady’s
finger, French beans, cucumber, lettuce, tomato, spring onion, radish, asparagus,
lastly the saccharine for sweetening.
Measured Diet: These are required for patients who are being treated with Insulin or
oral hypoglycemic agents and also for those who are overweight and are on a anti
obese regimen.
NUTRITON: 94
Medical Nutrition Therapy (MNT) is an integral component of Diabetes Management.
Nutritional Recommendations for Diabetics:
Carbohydrate: Whole grains, fruits, vegetables and low fat milk should be included
in the healthy diet. The total amount of carbohydrate in diet is more important than
source or type. As sucrose does not increase glycemia to a greater extent than
isocaloric amounts of starch, sucrose and sucrose containing foods do not need to be
restricted.
Protein: Protein intakes > 20% of total daily energy should be avoided.
Fat: Less than 10% of energy intake should be derived from saturated fats.
Cholesterol: <300 mg/day. Individuals with LDL>100 mg/dl should take cholesterol
<200 mg/day.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Vitamins and Minerals: As there is no evidence of benefit from it, vitamins and
minerals are not advisable if person do not have underlying deficiencies.
Antioxidant: Routine supplementation of antioxidants is not advised because of
uncertainties related to long term efficacy and safety.
Calorific Requirements: The approximate ratio in normal person’s diet is protein
12%, fat 42% and carbohydrate 46%, but in diabetics it is usually needed to be
modified as protein 15%, fat 35% and Carbohydrate 50%.
In Insulin requiring Diabetics the distribution of calories is very important to
avoid the hypoglycemia. A typical patient of IDDM usually require 20% of total
calories for breakfast, 35% for lunch, 30% for the dinner and 15% for the late evening
feedings. (Harrison 1997)
EXERCISE
Exercise and Type 1 diabetes: The ability to adjust the therapeutic regimen (Insulin
and MNT) to allow safe participation has been recognized as an important
management strategy in these individuals.
The individual with type 1 DM should follow these guidelines:
a. Metabolic control before physical activity.
b. Avoid physical activity if Fasting glucose > 250 mg/dl and ketosis is present.
c. Ingest added carbohydrate if glucose level < 100 mg/dl
d. Blood glucose monitoring before and after physical activity.
e. Food intake – Carbohydrate based foods should be readily available to avoid
hypoglycemia.
Exercise and Type 2 diabetes: The possible benefits of physical activity for the
patient with type 2 diabetes are substantial, and recent studies strengthen the
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
importance of long term discrete physical activity programs for the treatment and
prevention of Diabetes mellitus. It reduces the risk of cardiovascular disease,
Hyperlipidemia, Hypertension and Obesity. Recent studies reveal that exercise
increases Adiponectin levels and thus increase Insulin Sensitivity in humans.
DIABETIC QUALITY OF LIFE:
The World Health Organization (WHO) has established two main objectives
in caring for diabetic patients: first, maintain the health and quality of life of
individuals with diabetes through effective patient care and education and second,
treat and prevent complications of the disease which should decrease morbidity and
mortality as well as increase the therapeutic compliance of the patients.
The above elucidated Ayurvedic and Conventional modalities of treatment are
all aimed at bringing about good metabolic control at different levels of normal
physiological process of digestion, but achieving good metabolic control has been
found difficult in children, and particularly in adolescents. Having diabetes requires a
complex, intrusive and highly demanding daily programme for families with one or
more diabetic members in the family, which may have a negative effect on Quality of
Life (QOL). Good Quality of Life is associated with better metabolic control and it is
the subjects general and health related Quality Of Life which is gaining maximum
focus and has become an important outcome in any clinical studies and healthcare
interventions.
The World Health Organization (WHO) defines QOL as an “individual’s perception
of their position in life in the context of the culture and value systems in which they
live and in relation to their goals, expectatctions, standards and concerns. It is a broad
ranging concept, affected in a complex way by the person’s physical health,
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
psychological State, personal belief and social relationships to salient features of their
environment”.Other experts suggest that QOL is a multidimensional, subjective and
dynamic concept.
In medical sciences, QOL is used in 2 ways: general QOL or the general feeling of
well-being and health-related QOL, involving health-related problems for different
diseases. A number of questionnaires are available covering both aspects. The one
accepted and validated from the Diabetes control and complications trial – DCCT and
also world health organization approved field test instruments with questionaires can
be used for various clinical study.
The Future of Diabetes:
Scientists are now testing whether giving insulin injections or a pill might keep
people from getting diabetes, at least for a little while. Scientists are convinced that
some day in the future a treatment can be used to vaccinate all children against
Diabetes. Since 1971, scientists have been trying to create an artificial pancreas to try
to cure diabetes in people who clearly have it. With an artificial pancreas, a person
with diabetes could have controlled blood sugars without having to inject insulin. The
artificial pancreas is still years away, but scientists are confident that it is possible.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
DRUG REVIEW
Proper understanding of the characteristic features of the drug is very
important prior to the treatment procedure. This aspect has been well highlighted by
Acharya Charaka,
That drug, its pharmacodynamics and pharmacokinetics mentioned in the
Authentic Vedic Dictionaries – Nighantu, if not well assimilated by the administrating
physician then, it is not too far in bringing about deadly, harmful, severe adverse
events in the subject, just like a dreadful poison, dreadly weapons and a dangerous
lightning flash in bringing about the untowards effect. So, it is mandatory to be well
aware of pharmacological properties and actions of the individual drugs within the
investigational product.
Madhumeha, as already mentioned occur either due to Avaraka doshas like
Kapha and Pita within the Srotas’s thus interfering with the normal pathway of vayu.
So, Samprapti Vighatana forms the basic core for treating this diseased condition. The
Shamana Yoga selected for the present study comprises of seven drugs which are very
easily available and hypothesized to have the ability of breaking the above vicious
cycle of pathology along with Mehagna action synergistically.
VATSAKADI QWATHA110:
The reference for Vatsakadi Qwatha is available in Qwatha Kalpana
Adhyaya of the Sharangadhara Samhita containing Vatsaka, Haritaki, Vibhithaki,
Amalaki, Daruharidra, Musta and Bijaka as the ingredients taken in equal quantities.
The descriptions of these ingredients with regards to their nomenclature,
Chemical Composition, Classical Pharmacological Properties and Actions along with
their Humoral Effects and updated studies related to pre-clinical and clinical
evaluation are enlisted hereafter.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
TableNo.16 Pharmacodynamic properties of the drugs used in the formulation125
Drug Rasa Guna Virya Vipaka Doshagnata C.C124
1 Vatsaka Tikta
Kashaya
Laghu,
Ruksha
Sheeta Katu Kapha Pitha
Upashoshana
Anthraquinone
glycosides,
Alkaloids,
Flavanoids.
2 Haritaki Lavana
Varjitha
Pancha
Rasa
Laghu,
Ruksha
Ushna Madhura Tridoshagna,
Chakshushya,
Medohara,
Jvara↓
Tannins,
A. glycosides,
Polyphenolic
compounds
3 Vibhitaki Kashaya Laghu,
Ruksha
Ushna Madhura Kaphapithagna
Jvara↓
Tannic acid,
Gallic acid,
Glycosides.
4 Amalaki Lavana
Varjitha
Pancha
Rasa
Laghu,
Ruksha
Sheeta
Madhura
Tridoshagna
Jvara↓
Ascorbic acid
5 Darvi Tikta Laghu,
Ruksha
Ushna Katu? Kaphapithagna
Dosha Pachaka
Alkaloids
6 Musta Kashaya,
Katu,
Tikta
Laghu,
Ruksha
Sheeta Katu Kaphapithagna
Medohara
Trushna↓
Volatile oils
7 Bijaka Kashaya,
Katu,
Tikta
Laghu,
Ruksha
Ushna Katu Kaphapithagna
Medohara
Udarda↓
Tannins.
Bio Flavanoids
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
VATSAKA125
Gana : Arsoghna, Kandughna etc
Family : Apocynaceae.
Latin Name : Holarrhena antidysenterica (Roth) A.DC
Chemical Constituents : Conessine and related alkaloids.
Therapeutic Action : Deepana, Samagrahi, Upashoshaka.
Therapeutic Uses : Pravahika, Atisara, Arsha, Trushna.
Therapeutic Form and Dose: Stem Bark Decoction 20-30ml.
RECENT STUDIES124:
1. Anti-Bacterial activity of Holarrhena antidysenterica against enteric
pathogens118.
2. Anti-Bacterial steroid alkaloids from the stem bark of Holarrhena
antidysenterica119.
3. Anti-Diarrhoeal and Anti-Microbial activity of Holarrhena
antidysenterica119.
4. The in vitro Antioxidant activity and total phenolic content of four Indian
medicinal plants119.
5. Hepatoprotective activity of Holarrhena antidysenterica.
6. Cardioprotective activity of Holarrhena antidysenterica.
7. Anti Inflammatory activity of Holarrhena antidysenterica.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
HARITAKI125
Gana : Amalakyadi, Haritakyadi, Parushakadi, Trivruthadi,
Prajasthapana, Jvaraghna, Kustaghna.
Family : Combretaceae
Latin Name : Terminalia Chebula. Retz
Chemical Constituents : Tannins – 30% Chebulinic acid, 45% Tannic acid,
Gallic Acid, resins etc, Anthraquinones and
Polyphenolic Compounds.
Therapeutic Action : Sarvadoshaprashamana, Rasayana, Deepana,
Anulomana.
Therapeutic Uses : Vibandha, Aruci, Udavarta, Gulma, Udararoga, Arsha,
Pandu, Shotha, Jeernajvara, Vishamajvara, Prameha,
Shiroroga, Kasa, Tamaka Shwasa, Hrdroga.
Therapeutic Form and Dose: 3-6 g of the drug in Powder form.
RECENT STUDIES124:
1. Anti Mutagenic activity of Terminalia chebula.
2. Cardioprotective activity of Terminalia chebula.
3. Anti hemorrhagic activity of Terminalia chebula.
4. Anti Hyperlipidemic activity of Terminalia chebula.
5. Anti viral activity of Terminalia chebula119.
6. Anti parasitic activity of Terminalia chebula119.
7. Retinoprotective activity of Terminalia chebula.
8. Anti Inflammatory activity of Terminalia chebula.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
AMALAKI125
Gana : Triphala, Parusakadigana (Susruta),
Vayahsthapana, Virechanopaga (Charaka)
Family : Euphorbiaceae
Latin Name : Emblica officinalis Gaertn.
Syn. Phyllanthus emblica Linn
Chemical Constituents : Vitamin C, Tannin, Gallic acid, Tannic acid.
Therapeutic Action : Tridoshahara, Vrshya, Rasayana, Cakshushya.
Therapeutic Uses : Raktapita, Amlapita, Prameha, Daha
Therapeutic Form and Dose: 3-6 g of the drug in powder form.
RECENT STUDIES124:
1. Nephroprotective activity of Emblica officinalis.
2. Neurotonic effect activity of Emblica officinalis.
3. Anti carcinogenic activity of Emblica officinalis.
4. Anti Hyperlipidemic activity of Emblica officinalis.
5. Anti Ulcerogenic activity of Emblica officinalis119.
6. Anti Oxidant activity of Emblica officinalis119.
7. Anti Inflammatory activity of Emblica officinalis.
8. Anti Hyperglycemic activity of Emblica officinalis.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
VIBHITAKI125
Gana : Jvarahara, Virechanopaga.
Family : Combretaceae
Latin Name : Terminalia belerica Roxb.
Chemical constituents : Gallic acid, Tannic acid and Glycosides, Fructose,
Galactose, Glucose, Mannitol.
Therapeutic Action : Kaphapitagna, Bhedaka, Krimigna, Cakshushya,
Keshya.
Therapeutic Uses : Svarabheda, Netraroga, Kasa, Chardi, Krimiroga,
Vibandha
Therapeutic Form and Dose: 3-6 g of the drug in Powder form.
RECENT STUDIES124:
1. Retinoprotective activity of Terminalia belerica119.
2. Anti Hyperlipidemic activity of Terminalia belerica.
3. Anti platelet aggregation activity of Terminalia belerica.
4. Anti hyperglycemic activity of Terminalia belerica.
5. Anti inflammatory activity of Terminalia belerica.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
DARUHARIDRA125
Gana : Arsoghna, Kandugna, Lekhaneeya (Ch);
Haridradi, Musthadi, Lakshadi (Su)
Family : Berberidaceae
Latin Name : Coscinium fenestratum
Chemical constituent : Berberine.
Natural Habitat : SriLanka, Southern belt of Karnataka.
Therapeutic Action : Stanya Shodhana, Stanya Doshahara,
Dosha Pacana
Therapeutic Uses : Amatisara, Medoroga, Urustambha,
Karnaroga, Mukharoga, Netraroga,
Vrana, Meha.
Therapeutic Form and Dose : 5-10 ml of the drug in Qwatha form.
RECENT STUDIES124:
1. Retinoprotective activity of Coscinium fenestratum119.
2. Anti cancer activity of Coscinium fenestratum119.
3. Anti septic activity of Coscinium fenestratum119.
4. Hepatoprotective activity of Coscinium fenestratum119.
5. Nephroprotective activity of Coscinium fenestratum119.
6. Cardiotonic activity of Coscinium fenestratum119.
7. Anti ulcer activity of Coscinium fenestratum119.
8. Anti inflammatory activity of Coscinium fenestratum119.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
MUSTA125
Gana : Kandugna, Stanya Shodhaka - Charaka
Family : Cyperaceae
Latin Name : Cyperus rotundus.
Chemical constituents : Volatile oils
Therapeutic Action : Pitakaphahara, Sthoulyahara, Shotahara, Deepana,
Pacana, Grahi, Trushnanigrahana, Krimigna, Tvak
doshahara, Jvaragna, Vishaghna
Therapeutic Uses : Agnimandya, Ajirna, Trushna¸ Jvara, Samgrahi¸
Mutrakruchra, Stanyavikara, Sutikaroga, Atisara,
Amavata, Krimiroga.
Therapeutic Form and Dose: 3-6 g (Powder), 20-30 ml (Kwatha)
RECENT STUDIES124:
1. Anti diarrheal activity of Cyperus rotundus119.
2. Anti Hyperlipidemic activity of Cyperus rotundus119.
3. Hepatoprotective activity of Cyperus rotundus119.
4. Anti Bacterial activity of Cyperus rotundus119.
5. Anti Inflammatory activity of Cyperus rotundus119.
6. Anti Oxidant activity of Cyperus rotundus.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
BIJAKA125
Gana : Udarda Prashamana – Charaka.
Family : Fabaceae
Latin Name : Pterocarpus marsupium Roxb.
Chemical Constituents : Epicatechin, Marsupin, Pterostilbene.
Therapeutic Action : Saraka, Vatartidoshanut, Galadoshaghna, Keshya,
Tvacya, Raktamandalanalanashini, Kaphapitagna
Therapeutic Uses : Pandu, Prameha, Medodosha, Kushta, Krimiroga,
Shvitra, Madhumeha, Sthoulya
Therapeutic Form and Dose: 32-50 g of the drug for decoction
RECENT STUDIES124:
1. Anti Diabetic activity of Pterocarpus marsupium119.
2. Anti Hyperlipidemic activity of Pterocarpus marsupium119.
3. Hepatoprotective activity of Pterocarpus marsupium119.
4. Cardiotonic activity of Pterocarpus marsupium119.
5. Anti inflammatory activity of Pterocarpus marsupium.
6. Anti oxidant activity of Pterocarpus marsupium119.
7. Insulin like activity of Pterocarpus marsupium119.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
METHODOLOGY
The process of explaining the unexplained facts on the scientific grounds in a
systemic and orderly manner can be termed as Research and the scientific methods
adopted to explain the unexplained facts can be termed as the Research Methodology.
In the present clinical study, an attempt has been made to explain the Mehagna effect
- Anti hyperglycemic effect of a Polyherbal formulation cited in Ayurvedic classics.
MATERIALS:
For the present clinical study, the Polyherbal formulation selected is
Vatsakadi Qwatha110 mentioned in Sharangadhara Samhita, Madhyama khanda, 2nd
Chapter- Qwatha Kalpana Adhyaya- Mehagna context. The ingredients of the
Polyherbal formulation includes Vatsaka, Haritaki, Amalaki, Vibhitaki, Daruharidra,
Musta and Bijaka.
Method of Preparation of Qwatha110:
The ingredients of Vatsakadi Qwatha were individually taken in the quantity
of 6.5kgs each and made into coarse powder of the seven drugs. To this mixture of
total 45.5kgs drugs 4 times of water, i.e. 182 ltrs were added and is made to boil on
mild fire. It is subjected to fire until it is reduced to 1/4th.The Qwatha thus obtained is
filtered through a Clean Cloth and is collected in a Clean Sterile Container and is
measured to be 45 litres in quantity. It is then preserved by adding required amount of
Methyl Paraben- to the total quantity of the qwatha obtained. The Qwatha thus
prepared is stirred well for uniform dissolution of the preservative and is filled in the
bottles of 500ml capacity and is labeled and sealed appropriately.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
METHODS
SOURCE OF STUDY
a) Literary Source:
All available classical references bearing the description of Madhumeha is
referred to obtain the relevant literary data for the study and also all the available
electronic databases – Pubmed, Webmd and Biomed.
b) Pharmaceutical Source:
The Polyherbal formulation selected for the present work Vatsakadi
Qwatha is prepared in the pharmacy of A.L.N. Rao Memorial Ayurvedic Medical
College as per textual references. It is prepared according to the classical method of
Qwatha Kalpana told by Acharya Sharangadhara110.
c) Clinical Source:
Subjects of either sex diagnosed for Madhumeha on the basis of Classical
Clinical Features are selected from OPD and IPD of A.L.N Rao Ayurveda Medical
College and Hospital, Koppa.
Sampling Method:
Random sampling has been done from the adult population irrespective of sex,
religion and economic status satisfying the inclusion criteria.
Method of Collection of Data:
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Based on the classical signs and symptoms of Madhumeha the patients of
either sex between age group of 25-60 yrs are selected from the OPD and IPD of ALN
Rao Memorial Ayurveda College Hospital. Totally 30 members of patients is selected
for study purpose by random sampling method following inclusion and exclusion
criteria. The trial group has been given Vatsakadi Qwatha 50ml twice daily before
food in divided doses. The duration of the treatment is 45 days. For the purpose of
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
assessment, scoring has been given to all signs and symptoms from grade 0-3
according to severity and is documented appropriately before the treatment, after 15
days, 30 days and 45 days of the treatment and 90 days of follow up without
medication with an interval of 15 days. Statistical analysis is done by using paired
Student‘t’ test.
A) Inclusion Criteria123:
1. The patients with Prabhutamutrata, Avilamutrata, along with other signs and
symptoms like Pipasa Adhikata, Kshudha Adhikata, Karapada Daha, Karapada
Suptata, Swedapravruthi and Dourbalya is included for the present study.
2. Age group between 25123-60yrs of either sex is included for the present study.
3. The diabetic patients with Fasting Blood Sugar Level ranging from 126mg/dL-180
mg/dL and Post Prandial Blood Sugar level ranging from 160mg/dl - 250mg/dl is
included for the present study.
B) Exclusion Criteria123:
1. Age group > 60 yrs and < 25 yrs are excluded.
2. Fasting Blood Sugar Level < 126 mg/dl, Post Prandial Blood Sugar Level <140
mg/dl.
3. Patients suffering with systemic disorders like Renal Disorder, Cardiac disorder
etc.
4. Sahaja and Jathaja Madhumeha w.s.r to MODY and Gestational diabetes123.
5. Patient with diabetic gangrene, carbuncles and other diabetic complications.
DIAGNOSTIC CRITERIA123:
Patients were diagnosed on the basis of signs and symptoms related to
Madhumeha laid down in Ayurvedic Classics and Essential Laboratory Findings
explained for Diabetes Mellitus. They are given as follows.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
1. Prabhutamutrata 7. Karapada Suptata.
2. Avilamutrata 8. Dourbalya.
3. Pipasa Adhikata. 9. FBS ≥126mg/dl- 180mg/dl.
4. Kshudha Adhikata. 10. PPBS ≥200mg/dl-250mg/dl.
5. Swedapravruthi. 11. HBA1C
6. Karapada Daha 12. FUS and PPUS.
STUDY DESIGN:
Standardized Single Blind Clinical Study, done for a group of 20 subjects.
TableNo.17 Treatment Schedule
Sample size 20 patients
Medicine Vatsakadi Qwatha
Dose 50ml twice daily before
food in divided doses
Duration 45 days.
FOLLOW UP: The follow up of the study had been done for 90 days without
medication.
LABORATORY INVESTIGATIONS
FBS- Fasting Blood Sugar
PPBS- Post Prandial Blood Sugar.
FUS – Fasting Urine Sugar.
PPUS - Post Prandial Urine Sugar.
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HBA1c –Glycated/ Glycosalated Hemoglobin
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
Diabetic Quality Of Life – Questionaire**
Quality of life has gained maximum focus in the recent days especially in the disease
Diabetes Mellitus and has become an important outcome in any clinical trial and
healthcare interventions. So here an attempt will be made for assessing the Diabetic
Quality Of Life (DQOL) by selecting few relevant Questions from DCCT and
WHOQOL approved and validated Diabetic Quality Of Life – DQOL Questionaire
and Scoring. These Questions related will be assessed before and after the treatment
accordingly.
‐ 103
Sl no. QUESTIONS SCORING I. PHYSICAL 1. How often do you feel physically ill? 1 2 3 4 5
2. How often do you have bad night sleeps? 1 2 3 4 5
3. To what extent do you have difficulty in performing your routine activities?
1 2 3 4 5
4. How much are you bothered by any limitations in performing everyday living activities?
1 2 3 4 5
5. How often do you feel fatigue? 1 2 3 4 5
II. PSYCHOSOCIAL 1. How satisfied are you with your social relationship? 1 2 3 4 5
2. How often do you feel good about yourself? 1 2 3 4 5
3. Do you get the kind of support from others that you need?
1 2 3 4 5
4. How much do you experience positive feelings in your life?
1 2 3 4 5
5. How well are you able to concentrate? 1 2 3 4 5
III. SEXUAL 1. How often does your diabetes interfere with your sex
life? 1 2 3 4 5
2. How satisfied are you with your sex life? 1 2 3 4 5
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
3. How often are you worried about your sexual life? 1 2 3 4 5
4. Are you bothered by any difficulties in your sex life? 1 2 3 4 5
5. How well are your sexual needs fulfilled? 1 2 3 4 5
IV. SATISFACTION IN LIFE 1. How satisfied are you with the quality of your life? 1 2 3 4 5
2. How much do difficulties with transport restrict your life?
1 2 3 4 5
3. To what extent are you hopeful about your life? 1 2 3 4 5
4. To what extent do you feel peaceful within yourself? 1 2 3 4 5
5. To what extent does faith contribute to your well-being? 1 2 3 4 5
V. TREATMENT SATISFACTION 1. How willing are you to take medications? 1 2 3 4 5
2. How much do you need any medication to function in your daily life?
1 2 3 4 5
3. How dependent are you on medications? 1 2 3 4 5
4. How satisfied are you about the present treatment? 1 2 3 4 5
5. How confident are you with the outcome of the treatment?
1 2 3 4 5
HEALTH PERCEPTION*
1. Compared to others of your age would you say your health is
E G F P VP
**SOURCE - WHOQOL - SRPB field test instrument and DCCT approved and
validated Questionaire.
*Health Perception – E- excellent, G- good, F – fair, P- poor, VP-Very poor.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
CRITERIA FOR ASSESSMENT OF RESULTS WITH GRADING OF PARAMETERS
Table No.18 ASSESSMENT CRITERIA AND GRADING OF THE RESULTS
SUBJECTIVE PARAMETERS SL
NO: PARAMETER ASSESMENT RANGE SCORE
Prabhuta Mutrata(Polyuria) Amount of Urine: a) Normal 500ml-2500ml 0 b) Slightly increased 2500ml-3000ml 1 c) Increased 3000ml- 3500ml 2 d)Markedly Increased
>3500ml 3
Frequency of Urination: a) Normal 3-5 times /day & 0-1 times/ night 0 b) Slightly increased 6-8 times/ day & 1-2 times/ night 1 c) Increased 6-8 times/ day & 3-4 times/ night 2
1.
d)Markedly Increased
>8 times/ day & > 5 times/ night 3
2. Avilamutrata a) Normal a)Clearly readable letters 0 b) slightly increased b)Readable letters 1 c) Increased c)Can read with difficulty 2 d)Markedly
Increased d)Cannot read the letters 3
3. Pipasa Adhikata a) Normal 1.5-2 ltrs/day intake of water 0 b) Slightly increased 2-3 ltrs/day intake of water 1 c) Increased 3-4 ltrs/day intake of water 2 d)Markedly
Increased >4 litters intake of water 3
4. Kshudha Adhikata a) Normal Taking food 2-3 times a day 0 b) Slightly increased Taking food 4-5 times a day 1 c) Increased Taking food 6-7 times a day 2 d)Markedly
Increased Taking food >8 times a day 3
5. Swedapravruthi a) Normal Normal sweating by doing normal physical
exercise(daily work) 0
b) Slightly increased excessive sweating by doing normal physical exercise(daily work)
1
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‐ 106
c) Increased excessive sweating even by walking some distance or stepping a ladder (even by mild daily work)
2
d)Markedly Increased
Excessive sweating even at rest also. 3
6. Karapada Daha a) Normal Absent 0 b) Slightly increased occasionally mildly present 1 c) Increased constantly mildly present 2 d)Markedly
Increased severely present 3
7. Karapada Suptata a) Normal Absent 0 b) Slightly increased occasionally mildly present 1 c) Increased constantly mildly present 2 d)Markedly
Increased severely present 3
8. Dourbalya a) Normal can do normal physical exercise(daily work )
without any difficulty 0
b) Slightly increased can do normal physical exercise(daily work )with some difficulty
1
c) Increased can do normal physical exercise(daily work )with much difficulty
2
d)Markedly Increased
Cannot do daily activities 3
OBJECTIVE PARAMETERS 9 Blood Sugar FASTING BLOOD SUGAR a) Normal 80-126mg/dl 0 b) Slightly increased 126-150mg/dl 1 c) Increased 150-180mg/dl 2 d)Markedly
Increased >180mg/dl 3
10 POST PRANDIAL BLOOD SUGAR
a) Normal 126-160mg/dl 0 b) Slightly increased 161-190mg/dl 1 c) Increased 190-220mg/dl 2 d)Markedly
Increased 221-250mg/dl 3
11 FASTING URINE SUGAR Normal Absence of glucose in urine (No ppt) 0
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
Slightly increased Presence of 0.5% of glucose in urine (Green ppt)
1
Increased Presence of 1 % of glucose in urine (Yellow ppt)
2
Markedly Increased Presence of 1.5% of glucose in urine (Orange ppt)
3
12 POST PRANDIAL URINE SUGAR
Normal Absence of glucose in urine (No ppt) 0 Slightly increased Presence of 0.5% of glucose in urine (Green
ppt) 1
Increased Presence of 1 % of glucose in urine (Yellow ppt)
2
Markedly Increased Presence of 1.5% of glucose in urine (Orange ppt)
3
13 GLYCATED / GLYCOSALATED HEMOGLOBIN – HBA1C Normal <8% 0 Good control 8-9% 1 Fair control 9-10% 2 Poor control >10% 3 12 DIABETIC QUALITY OF LIFE
Not at all 1 A little 2 Moderate amount 3 Very much 4 Extreme amount 5
OVERALL ASSESSMENT CRITERIA
The overall effect of the therapy was assessed as stated below.
1. A patient in whom there was reduction in the assessment criteria to grade 0 against
the initial severity scoring is considered as 90%-100% response. It is considered as
good response.
2. Patient in whom there was reduction in 2 levels of the assessment criteria against the
initial severity scoring is taken as 60%-90% response. It is taken as marked response.
3. Patient in whom there was reduction in one level of the assessment criteria against the
initial severity scoring is taken as 30%-60% response. It is taken as mild response.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
4. Patients in whom assessment criteria remained same against the initial severity
scoring is taken as 0-30% response and is considered as poor response.
OVERALL ASSESSMENT CRITERIA
Table No. 19 Overall Assessment Criteria
Percentage of cure Interpretation
76-100% Good Response
50-75% Moderate Response
26-49% Mild Response
0- 25% Poor Response
STATISTICAL ANALYSIS:
Here the effect of drug administration has been critically analyzed by the
statistical data. Descriptive Statistical Data which includes Mean, Standard Deviation
(S.D), Standard Error (S.E), t- value and P- value were calculated for all the variables.
Post-therapeutic effect of the administered drug is assessed by paired student‘t’ test.
For all the tests, a ‘P’ value of < 0.05 is considered as the statistical significance level
for obtaining accurate result.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
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OBSERVATION
In this present clinical study, 30 subjects were enrolled. Among the 30
subjects enrolled, 5 subjects were excluded from the study based on the exclusion
criteria. Among rest of 25 subjects who fulfilled the inclusion criteria were taken for
the study, out of which 5 subjects were discontinued during various stages of the
treatment. Finally only 20 subjects who completed the full course of treatment with
follow up observation were taken for observation and statistical analysis. Following
pages contain the descriptive observational analysis of the subjects. These
observations are compiled under the following heading.
A. Demographic Data of the Study.
B. Clinical Data of the Study.
C. Data related to the Diabetic Quality Of Life.
D. Data Related to Results of the Study.
A. DEMOGRAPHIC DATA
1. Data showing Agewise Distribution of the 20 subjects.
Table No: 20 Agewise Distribution of the 20 subjects.
AGE RANGE No. OF SUBJECTS PERCENTAGE
25-30 00 0%
31-35 01 05%
36-40 04 20%
41-45 07 35%
46-50 00 00%
51-55 04 20%
56-60 04 20%
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Majority of the subjects were between the age range 41-45 i.e about 07
subjects among the 20 subjects accounting for 35% of the total observation. Between
the age ranges 36-40, 51-55 and 56-60; about 04 subjects in each ranges accounting
for 20% in each of the total observation were observed. Only one subject was found
between the age group of 31-35, which accounts for about 5% of the total observation.
Chart No: 4 Agewise Distribution Chart No: 5 Sexwise Distribution
2. Data Showing Sexwise Distribution of the 20 Subjects.
Table No: 21 Sexwise Distribution of the 20 subjects.
Sex Number Percentage
Males 05 25%
Females 15 75%
Majority of the subjects were female’s i.e about 15 subjects among the 20
subjects taken for the study accounting for about 75% of the total observation.
Remaining 05 subjects were male, accounting for about 25% of the total observation.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
3. Data of Religoinwise Distribution of 20 subjects.
Table No: 22 Religoinwise Distribution of 20 subjects.
RELIGION NUMBER PERCENTAGE
Hindu 14 70%
Muslim 06 30%
In the present study, 70% i.e about 14 of the 20 subjects were Hindus and
remaining 15% i.e about 06 subjects were Muslims.
Chart No: 6 Religoinwise Chart No: 7 Educationwise
Distribution Distribution
4. Distribution of Educational Qualifications of the 20 subjects.
Table No: 23 Educationwise Distributions of the 20 Subjects.
EDUCATION NO OF SUBJECTS PERCENTAGE
Primary level 03 15%
Secondary level 04 20%
High school level 04 20%
Graduate level 07 35%
Illiterate 02 10%
It is observed that 35% of the total observation i.e 8 subjects of the 20 subjects
had the education at Graduate Level, 20% each i.e 4 subjects each from the 20
subjects were educated to the level of Secondary and High School Level, 15% i.e 03
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
subjects of the 20 subjects were educated to the Primary Level and remaining 10% i.e
02 subjects of the 20 subjects were Illiterates.
Chart No: 8 Marital Statuswise Chart No: 9 Occupationwise
5. Data of Marital Statuswise Distributions of the 20 Subjects.
Table No: 24 Marital Statuswise Distributions of the 20 Subjects.
MARITAL STATUS NO OF SUBJECTS PERCENTAGE
Married 17 85%
Single 03 15%
In the present study, 85% i.e 17 of the 20 subjects were Married and
remaining 15% i.e 03 subjects were unmarried or single.
6. Data related to Occupationwise Distribution of the 20 Subjects.
In the present study, 55% i.e 11 subjects were homemakers, 20% i.e 04
subjects were teachers, 10% i.e 02 subjects were officials and remaining were equally
distributed with 5% i.e 01 subjects each were Watchman, Attender, and Engineer
respectively.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Table No: 25 Occupationwise Distributions.
OCCUPATION NO OF SUBJECTS PERCENTAGE
Homemaker 11 55%
Teacher 04 20%
Officer 02 10%
Watchman 01 5%
Attender 01 5%
Engineer 01 5%
7. Data related to habitat distributions of the 20 subjects.
Table No: 26 Percentage of distribution of Habitat.
HABITAT NO OF SUBJECTS PERCENTAGE
Urban 08 40
Rural 12 60
In the present study, 60% i.e 12 subjects of the 20 subjects were among Rural
population and remaining 40% i.e 08 subjects were among Urban population.
Chart No: 10 Habitatwise. Chart No: 11 Socioeconomic Statuses.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
8. Data Related to the Socio Economic Status of the 20 Subjects.
Table No: 27 Distribution of Socio economic Status of the 20 Subjects.
SOCIOECONOMIC STATUS NO OF SUBJECTS PERCENTAGE
Higher income group 01 5%
Middle income group 14 70%
Low income group 05 25%
In the present study, 70% i.e 14 subjects of the 20 subjects were from Middle
Income Group, 25% i.e 05 subjects were from Low Income Group and remaining 5%
i.e one subject was from High Income Group.
9. Distribution of Desapradhanatha
Table No: 28 Distribution of Desapradhanatha
DESA NUMBER PERCENTAGE
Sadharana 4 20
Anupa 16 80%
In the present study, 80% i.e 16 subjects of the 20 subjects were residing in
Jangaladesa and remaining 20% i.e 04 subjects were residing in Sadharanadesha.
Chart No: 12 Percentage of Desapradhanatha
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
B.SUBJECT’S CLINICAL DATA
1. Data Related to Chief Complaints.
Table No: 29 Data Related to Chief Complaints.
CHIEF COMPLAINTS NO. OF SUBJECTS PERCENTAGE
Frequency 16 80% Prabhutmutrata
Amount 16 80%
Avila Mutrata 20 100%
Pipasa Adhikata 14 70%
Kshudha Adhikata 10 50%
Sweda Pravruthi Adhikata 17 85%
Karapadathaladaha 19 95%
Karapadathalasupti 17 85%
Dourbalya 20 100%
In the present study, 100% i.e 20 out of 20 subjects had Avila Mutrata (AM)
and Dourbalya (D), 95% i.e 19 out of 20 subjects had Karapadadaha (KD), 85% i.e 17
out of 20 subjects had Sweda Pravruthi Adhikata (SP) and Karapadasupti (KS), 80%
i.e 16 out of 20 subjects had Prabhutamutrata (PM), 70% i.e 14 out of 20 subjects had
Pipasa Adhikata (PA) and 50 % i.e 10 out of 20 subjects had Kshudha Adhikata (KA)
as their Chief Complaints.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
2. Data Related to the History of Present Illness: In the present study, it was found that 45% i.e 9 out of 20 subjects were
accidentally diagnosed with the complaint of Pruritis vulvae while remaining 55%
were diagnosed with the classical symptoms of Madhumeha.
3. Data Related to the History of Past Illness:
In the present study, it was found that 40% i.e 8 out of 20 subjects were having
the previous history of cold, cough and fever in common
4. Data related to Family History.
Table No: 30 Data related to Family History.
FAMILY HISTORY NO OF SUBJECTS PERCENTAGE
Present 00 0%
Absent 20 100%
In the present study, 100% i.e 20 out of 20 subjects showed no family history.
Chart No: 14 Data on Family History Chart No: 15 Data on Diet
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
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5. Data related to Personal History:
a) Data related to Dietary regimen.
Table No: 31 Data related to Dietary regimen.
Dietary Regimen No of subjects Percentage
Untimely Vegetarian 11 55%
Untimely Mixed 9 45%
In the present study, 55% i.e 11 out of 20 subjects were having Untimely
Vegetarian Dietary Regimen and remaining 45% i.e 9 out of 20 subjects were
observed to have Untimely Mixed Dietary Regimen.
b) Data related to Supplementary Diet
Table No: 32 Data related to Supplementary Diet
Supplementary diet No of subjects Percentage
Tea 8 40%
Coffee 10 50%
Milk 2 10%
Cool drinks 3 15%
Junks/Chats 10 50%
In the present study, 8 subjects i.e 40% had the habit of taking tea, 10
subjects i.e 50% had the habit of taking coffee, 2 subjects i.e 10% had the habit of
taking milk, 3 subjects i.e 15% had the habit of taking cool drinks and 10 subjects i.e
50% had the habit of taking junks / chats.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Chart no.16 Data on Supplementary Diet Chart no.17 Data on Nidra
c) Data related to Nidra
Table No: 32 Data related to Nidra
Nidra No of subjects Percentage
Disturbed 10 50%
Undisturbed 10 50%
In the present study, 10 of 20 subjects i.e 50% had disturbed sleep and
another 10 of 20 subjects i.e 50% had undisturbed sleep.
4. Data related to General Examination:
a) Data related to Body Mass Index
Table No: 32 Data related to Body Mass Index
BMI No of subjects Percentage
19-23 ( Normal) 17 85%
23-27(Over Weight) 02 10%
27-31(Obese) 01 05%
31-35(Very Obese) 00 0%
In the present study, 85% i.e 17 out of 20 subjects were observed to have
normal body mass index while 10% i.e 2 subjects were observed to fall under over
weight and only 05% i.e one out of 20 subjects was observed to fall under the obese.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Chart no.18 Data related to BMI Chart no.19 Data on Blood Pressure
b) Data Related To Blood Pressure:
Table no.33 Data Related To Blood Pressure
BLOOD PRESSURE NO. of
SUBJECTS PERCENTAGE
110/70 mm of Hg 07 35%
120/80 mm of Hg 07 35%
130/90 mm of Hg 06 30%
In the present study, 35% i.e 07 out of 20 subjects were observed to
have shared equally with 110/70 mm of Hg and 120/80 mm of Hg, while 30% i.e 06
subjects out of 20 subjects were observed to 130/90 mm of Hg.
c) Data Related To the Mean Biochemical Values
Table No: 38 Data related Mean Biochemical Values
Biochemical tests Mean values
FBS 176mg/dl
PPBS 226mg/dl
HBA1C 8.2%
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
‐ 121‐
5. Data related to Ashtasthana Pareeksha:
a) Data related to Nadi
Table No: 38 Data related to Nadi
Nadi No of subjects Percentage
Vatapitaja 10 50%
Drutha 07 35%
Manda 4 20%
In the present study, Sadharana nadi was observed for 50% i.e in 10 subjects.
Drutha was observed for 35% i.e 07 subjects out of 20 and finally Manda nadi was
observed for 20% i.e. 04 subjects out of 20 subjects.
b) Data related to Mutra:
In the present study, 80% i.e 16 subjects of the 20 subjects were observed
to have Prabhootamootrata and 100% i.e 20 subjects out of 20 subjects were observed
to have Avilamutrata and there was no burning Micturition and other systemic related
Clinical features but it was also observed that 05 subjects out of 20 subjects who had
Avilamutrata had sticky and foul odour and remaining 16 subjects were observed to
have aggravated Pruritis vulvae especially after micturition.
c) Data related to Mala:
In the present study, 80% i.e 16 subjects of the 20 subjects were observed
to have irregular bowel habit with easy evacuation but, remaining 20% i.e 04 out of
20 subjects were observed to have irregular bowel habit with difficulty in evacuation
and hard stools.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
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d) Data related to Jihwa:
In the present study, 80% i.e 16 subjects of the 20 subjects were observed
to have dryness of the tongue along with 45% i.e 09 subjects out of 20 subjects were
observed to have whitish coating over the tongue.
e) Data related to Sabda:
No abnormalities in the Sabda have been observed in any subject.
f) Data related to Sparsa:
Table No: 39 Data related to Sparsa:
Sparsa No of subjects Percentage
Ushna 16 80%
Sheeta 04 20%
g) Data related to Druk:
In the present study, none of the subjects were observed to have pallor and
other visual defects.
h) Data related to Akruthi:
Table No: 40 Data related to Akruthi:
AKRUTHI No of SUBJECTS PERCENTAGE
Pravaram 02 10%
Madhyamam 18 90%
Avaram 00 00%
In the present study, 18 subjects i.e 90% showed Madhyama Akruthi and only 2
subjects i.e 10% showed Pravara Akruthi.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
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6) Data related to Dasavidha Pareeksha:
a) Data related to Prakruthi
Table No: 41 Data related to Prakruthi
Prakruthi No of subjects Percentage
Pithakapha 01 05%
Kaphavata 02 10%
Vatapita 05 25%
Kaphapita 05 25%
Vatakapha 07 35%
Pitavata 00 00%
In the present study, Pitakapha was observed in 05% i.e 01 out of 20 subjects,
Kaphavata was observed in 10% i.e 02 out of 20 subjects, Vatapita was observed in
25% i.e 05 out of 20 subjects, Kaphapita was observed in 25% i.e 05 out of 20
subjects, Vatakapha was observed in 35% i.e 07 out of 20 subjects, Pitavata were
observed nil among the 20 subjects.
b) Data related to Vikruthi:
Table No: 42 Data related to Vikruthi:
Vikruthi involved No of subjects Percentage
Rasa 20 100%
Medas 20 100%
Raktha 17 85%
Mamsa 18 90%
Majja 10 50%
Sukra 09 45%
Kleda 20 100%
Lasika 20 100%
Oja 10 50%
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
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In the present study, Rasa, Medas, Kleda and Lasika dushti was observed in
100% of the subjects. Majja and Ojo dushti was observed in 50% of the subjects.
Raktha Dushti was observed in 85% of subjects. Mamsa Dushti was observed in 90%
of the subjects and Shukra Dushti was observed in 45% of the subjects.
c) Data related to Satvataha:
In the present study, 85% i.e 17 subjects out of 20 were observed to have
Madhyama Satva and 15% i.e 03 subjects out of 20 were observed to have Avara
Satva.
d) Data related to Satmyatha:
In the present study, 80% i.e 16 subjects out of 20 were observed to have
Madhyama Satmyata and 20% i.e 04 subjects out of 20 were observed to have Avara
Satmyata.
e) Data related to Ahara Shakthitaha:
In the present study, 50% of the subjects were observed to have Madhyama
Ahara shakti while remaining 50% were observed for Pravara Ahara shakti.
f) Data related to Vyayama Shakthitaha:
Table No: 43 Data related to Vyayama Shakthitaha:
Vyayamasakthi Number of subjects. Percentage
Pravaram 02 10%
Madhyamam 16 80%
Avaram 02 10%
In the present study only 2 subjects each showed Pravara and Avara vyayama
shakti while remaining dominated with Madhyama vyayama shakti i.e 16 subjects
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
‐ 125‐
g) Data related to Vaya
Table No: 44 Data related to Vaya:
Age No of subjects Percentage
Balyavastha 00 00
Madhyamavastha 16 80%
Vrudhavastha 04 20%
In the present study 80% i.e 16 subjects out of 20 were observed to be in
Madhyamavastha and 20% i.e 04 subjects out of 20 were observed to be in
Vrudhavastha.
7). Data related to Nidana:
Table No: 45 Data related to Nidana:
Nidana No of subjects Percentage
Asyasukham 20 100%
Swapnasukham 20 100%
Carbohydrate rich diet 20 100%
Fat rich diet 20 100%
Manasika Nidana 20 100%
Lack of exercise 20 100%
In the present study, Asyasukham- in terms of taking excessive sweet and its
by products, Swapnasukham – in terms of sedentary lifestyles, intake of carbohydrate
- Rice, Jaggery and Grains, while fat rich dietary items like curd, butter and non
vegetarian food items was observed in all the subjects.
It was also observed for vihara like sedentary sitting and sexual habits along
with lack of exercise in 100% i.e 20 subjects out of 20 subjects. Chinta
shokadodvegadi Manasika Nidana was also observed in 100% i.e 20 subjects out of
20 subjects.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
‐ 126‐
9) Data related to Purvarupa:
Table No: 47 Data related to Purvarupa:
Purvarupa No of subjects Percentage
Karapadathaladaha 19 95%
Pipasa 17 85%
Dantamalam 18 90%
Nayanamalam 08 40%
Karnamalam 02 10%
Alasyam 19 95%
Shareera Dourgandhyam 12 60%
Athitandra 15 75%
Athinidra 15 75%
Karapadathalasupti 15 75%
Kesheshu Jatilibhava 02 10%
Asyamadhuryam 02 10%
In the present study, Karapadadaha and Alasya was observed as a purvarupa
for 19 subjects (95%), Dantamalam for 18 subjects (90%), Pipasa for 17% (85%),
Athinidra, Athitandra and Karapadatala Supti for 15 subjects (75%), Nayanamalam
for 08 subjects (40%), Shareera Dourgandhyam for 12 subjects (60%), Kesheshu
Jatilibhava and Asyamadhuryam was observed in 02 subjects (10%).
10) Data Related To Upashaya:
Table no. Data Related To Upashaya
Upashaya No of subjects Percentage
Nimba Patra 20 100%
Guduchi Patra 20 100%
Menthe Powder 20 100%
Walking 19 100%
Exercise 19 100%
Yoga 02 10%
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
11) Data Related To Sroto Dushti:
Table no. Data Related To Sroto Dushti
Sroto dushti No of subjects Percentage
Rasavaha 20 100%
Raktavaha 19 95%
Medovaha 18 90%
Udakavaha 14 70%
Annavaha 10 50%
Mutravaha 16 80%
C. Data Related To Diabetic Quality Of Life:
Table no. Data Related To Diabetic Quality Of Life
Questions Affected No of subjects Percentage
Physical 20 100%
Psychosocial 10 50%
Sexual 18 90%
Life satisfaction 14 70%
Treatment satisfaction 10 50%
Health perception 16 80%
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
RESULTS
EFFECT OF VATSAKADI QWATHAON MADHUMEHA
The Statistical analysis over the effect of Vatsakadi Qwatha after 15,30,and 45
days of treatment period and 90 days of follow-up period are hereby calculated using
paired Student‘t’ test. The statistical analytical reports are as follows,
Effect of Vatsakadi Qwatha on Subjective Parameters
1. Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased amount of
urination)
Table No: 48 Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased
amount of urination)
Mean No Data
BT AT % S.D S.E T P
1. AT 15 days 1.60 1.30 18.75 0.22 0.10 2.78 <0.02
2. AT 30 days 1.60 0.90 41.92 0.22 0.10 6.48 <0.001
3. AT 45 days 1.60 0.60 61.29 0.57 0.17 5.45 <0.001
4. AFU-90 days 1.60 0.90 38.70 0.46 0.15 3.84 <0.01
Vatsakadi Qwatha provided mild significant (P<0.02) relief by 18.75% in the
symptom Prabhuta mutrata (amount of urine) after 15 days of treatment. Vatsakadi
Qwatha provided highly significant (P<0.001) relief by 41.92% in the symptom
Prabhuta mutrata (amount of urine) after 30 days of treatment. Vatsakadi Qwatha
provided highly significant (P<0.001) relief by 61.29% in the symptom Prabhuta
mutrata (amount of urine) after 45 days of treatment. Vatsakadi Qwatha provided
moderately significant (P<0.01) relief by 38.70% in the symptom Prabhuta mutrata
(amount of urine) after 90 days follow-up period.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
2. Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased frequency of
urination)
Table No: 49 Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased
frequency of urination)
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.70 1.35 20.58 0.23 0.11 3.13 <0.02
2. AT 30 days 1.70 0.95 44.11 0.19 0.10 7.35 <0.001
3. AT 45 days 1.70 0.40 76.47 0.64 0.18 7.07 <0.001
4. AFU-90 days 1.70 1.05 38.82 0.55 0.17 3.80 <0.01
Vatsakadi Qwatha provided mild significant (P<0.02) relief by 20.58% in the
symptom Prabhuta mutrata (frequency) after 15 days of treatment. Vatsakadi Qwatha
provided highly significant (P<0.001) relief by 44.11% in the symptom Prabhuta
mutrata (frequency) after 30 days of treatment. Vatsakadi Qwatha provided highly
significant (P<0.001) relief by 76.47% in the symptom Prabhuta mutrata (frequency)
after 45 days of treatment. Vatsakadi Qwatha provided moderately significant
(P<0.01) relief by 38.82% in the symptom Prabhuta mutrata (frequency) after 90 days
follow-up period.
3. Effect of Vatsakadi Qwatha on Avila Mutrata
Table No: 50 Effect Of Vatsakadi Qwatha on Avila Mutrata
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.80 1.50 16.66 0.22 0.10 2.78 <0.02
2. AT 30 days 1.80 0.95 47.22 0.55 0.17 4.97 <0.001
3. AT 45 days 1.80 0.50 72.22 0.43 0.15 8.62 <0.001
4. AFU-90 days 1.80 1.30 27.77 0.26 0.11 4.24 <0.001
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Vatsakadi Qwatha provided mild significant (P<0.02) relief by 16.66% in the
symptom Avila mutrata after 15 days of treatment. Vatsakadi Qwatha provided
highly significant (P<0.001) relief by 47.22% in the symptom Avila mutrata after 30
days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by
72.22% in the symptom Avila mutrata after 45 days of treatment. Vatsakadi Qwatha
provided highly significant (P<0.001) relief by 27.77% in the symptom Avila mutrata
after 90 days follow-up period.
4. Effect of Vatsakadi Qwatha on Pipasa Adhikata
Table No: 51 Effect Of Vatsakadi Qwatha on Pipasa Adhikata
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.05 0.80 23.08 0.40 0.14 1.70 <0.05
2. AT 30 days 1.05 0.35 66.06 0.85 0.21 3.30 <0.01
3. AT 45 days 1.05 0.30 71.42 0.72 0.19 3.84 <0.01
4. AFU-90 days 1.05 0.45 57.14 0.67 0.18 3.18 <0.01
Vatsakadi Qwatha provided significant (P<0.05) relief by 23.08% in the
symptom Pipasa Adhikata after 15 days of treatment. Vatsakadi Qwatha provided
moderately significant (P<0.01) relief by 66.06% in the symptom Pipasa Adhikata
after 30 days of treatment. Vatsakadi Qwatha provided moderately significant
(P<0.01) relief by 71.42% in the symptom Pipasa Adhikata after 45 days of treatment.
Vatsakadi Qwatha provided moderately significant (P<0.01) relief by 27.77% in the
symptom Pipasa Adhikata after 90 days follow-up period.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
5. Effect of Vatsakadi Qwatha on Kshudha Adhikata
Table No: 52 Effect of Vatsakadi Qwatha on Kshudha Adhikata
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 0.70 0.50 28.57 0.16 0.09 2.12 <0.05
2. AT 30 days 0.70 0.25 64.28 0.47 0.15 2.85 <0.02
3. AT 45 days 0.70 0.25 85.71 0.46 0.15 3.84 <0.01
4. AFU-90 days 0.70 0.30 57.14 0.35 0.13 2.91 <0.01
Vatsakadi Qwatha provided significant (P<0.05) relief by 28.57% in the
symptom Kshudha Adhikata after 15 days of treatment. Vatsakadi Qwatha provided
mild significant (P<0.02) relief by 64.28% in the symptom Kshudha Adhikata after 30
days of treatment. Vatsakadi Qwatha provided moderately significant (P<0.01) relief
by 85.71% in the symptom Kshudha Adhikata after 45 days of treatment. Vatsakadi
Qwatha provided moderately significant (P<0.01) relief by 57.14% in the symptom
Kshudha Adhikata after 90 days follow-up period.
6. Effect of Vatsakadi Qwatha on Sweda-Pravruthi
Table No: 53 Effect of Vatsakadi Qwatha on Sweda Pravruthi
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.30 1.20 7.69 0.094 0.07 1.41 <0.05
2. AT 30 days 1.30 0.70 46.15 0.35 0.13 4.37 <0.001
3. AT 45 days 1.30 0.45 66.38 0.66 0.18 4.55 <0.001
4. AFU-90 days 1.30 0.60 53.84 0.32 0.13 5.34 <0.001
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Vatsakadi Qwatha provided significant (P<0.05) relief by 7.69% in the
symptom Sweda Pravruthi after 15 days of treatment. Vatsakadi Qwatha provided
highly significant (P<0.001) relief by 46.15% in the symptom Sweda Pravruthi after
30 days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief
by 85.71% in the symptom Sweda Pravruthi after 45 days of treatment. Vatsakadi
Qwatha provided highly significant (P<0.001) relief by 53.84% in the symptom
Sweda Pravruthi after 90 days follow-up period.
7. Effect of Vatsakadi Qwatha on Karapada Daha
Table No: 54 Effect of Vatsakadi Qwatha on Karapada Daha
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.40 1.10 21.40 0.22 0.10 2.78 >0.05
2. AT 30 days 1.40 0.45 67.85 0.15 0.09 10.50 <0.001
3. AT 45 days 1.40 0.25 82.14 0.34 0.13 8.53 <0.001
4. AFU-90 days 1.40 0.65 53.57 0.30 0.12 5.94 <0.001
Vatsakadi Qwatha provided significant (P<0.05) relief by 21.40% in the
symptom Karapada Daha after 15 days of treatment. Vatsakadi Qwatha provided
highly significant (P<0.001) relief by 67.85% in the symptom Karapada Daha after 30
days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by
82.14% in the symptom Karapada Daha after 45 days of treatment. Vatsakadi
Qwatha provided highly significant (P<0.001) relief by 53.57% in the symptom
Karapada Daha after 90 days follow-up period.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
8. Effect of Vatsakadi Qwatha on Karapada Suptata
Table No: 55 Effect of Vatsakadi Qwatha on Karapada Suptata
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 0.90 0.80 11.11 0.09 0.070 1.41 <0.05
2. AT 30 days 0.90 0.45 32.14 0.36 0.13 3.24 <0.02
3. AT 45 days 0.90 0.25 46.42 0.45 0.15 4.22 <0.001
4. AFU-90 days 0.90 0.35 39.28 0.26 0.11 4.69 <0.001
Vatsakadi Qwatha provided significant (P<0.05) relief by 11.11% in the
symptom Karapada Suptata after 15 days of treatment. Vatsakadi Qwatha provided
mild significant (P<0.02) relief by 32.14% in the symptom Karapada Suptata after 30
days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by
46.42% in the symptom Karapada Suptata after 45 days of treatment. Vatsakadi
Qwatha provided highly significant (P<0.001) relief by 39.28% in the symptom
Karapada Suptata after 90 days follow-up period.
9. Effect of Vatsakadi Qwatha on Dourbalya
Table No: 56 Effect of Vatsakadi Qwatha on Dourbalya
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.55 1.30 16.12 0.19 0.10 2.45 <0.05
2. AT 30 days 1.55 0.20 87.09 0.23 0.11 12.02 <0.001
3. AT 45 days 1.55 0.15 90.32 0.56 0.17 8.09 <0.001
4. AFU-90 days 1.55 0.70 54.85 0.55 0.17 4.97 <0.001
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Vatsakadi Qwatha provided significant (P<0.05) relief by 16.12% in the
symptom Dourbalya after 15 days of treatment. Vatsakadi Qwatha provided highly
significant (P<0.001) relief by 87.09% in the symptom Dourbalya after 30 days of
treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by 90.32%
in the symptom Dourbalya after 45 days of treatment. Vatsakadi Qwatha provided
highly significant (P<0.001) relief by 54.85% in the symptom Dourbalya after 90 days
follow-up period.
Effect of Vatsakadi Qwatha on Objective Parameters
1. Effect of Vatsakadi Qwatha on Fasting Blood Sugar:
Table No: 57 Effect of Vatsakadi Qwatha on Fasting Blood Sugar
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.80 1.50 17.64 0.22 0.10 2.78 <0.05
2. AT 30 days 1.80 0.55 67.64 0.30 0.12 9.90 <0.001
3. AT 45 days 1.80 0.15 83.33 0.26 0.11 12.74 <0.001
4. AFU-90 days 1.80 0.65 63.88 0.34 0.13 8.5 <0.001
Vatsakadi Qwatha provided significant (P<0.05) change by 17.64% in Fasting
Blood Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided highly
significant (P<0.001) change by 67.64% in Fasting Blood Sugar Level after 30 days
of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by
83.33% in Fasting Blood Sugar Level after 45 days of treatment. Vatsakadi Qwatha
provided highly significant (P<0.001) change by 63.88% in Fasting Blood Sugar
Level after 90 days follow-up period.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
2. Effect of Vatsakadi Qwatha on Post Prandial Blood Sugar
Table No: 58 Effect of Vatsakadi Qwatha on Post Prandial Blood Sugar
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 1.90 1.60 15.78 0.22 0.10 2.78 >0.02
2. AT 30 days 1.90 0.80 57.89 0.09 0.07 15.57 <0.001
3. AT 45 days 1.90 0.15 89.47 0.43 0.15 11.27 <0.001
4. AFU-90 days 1.90 0.65 65.78 0.40 0.14 8.52 <0.001
Vatsakadi Qwatha provided mild significant (P<0.05) change by 15.78% in
Post Prandial Blood Sugar Level after 15 days of treatment. Vatsakadi Qwatha
provided highly significant (P<0.001) change by 57.89% in Post Prandial Blood
Sugar Level after 30 days of treatment. Vatsakadi Qwatha provided highly significant
(P<0.001) change by 89.47% in Post Prandial Blood Sugar Level after 45 days of
treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by
65.78% in Post Prandial Blood Sugar Level after 90 days follow-up period.
3. Effect of Vatsakadi Qwatha on Fasting Urine Sugar:
Table No: 59 Effect of Vatsakadi Qwatha on Fasting Urine Sugar
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 0.65 0.50 23.07 0.13 0.08 1.78 <0.05
2. AT 30 days 0.65 0.15 76.90 0.47 0.15 3.16 <0.01
3. AT 45 days 0.65 0.15 84.67 0.36 0.13 3.96 <0.001
4. AFU-90 days 0.65 0.40 38.46 0.30 0.12 1.98 <0.05
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Vatsakadi Qwatha provided significant (P<0.05) change by 23.07% in Fasting
Urine Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided moderately
significant (P<0.01) change by 76.90% in Fasting Urine Sugar Level after 30 days of
treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by
84.67% in Fasting Urine Sugar Level after 45 days of treatment. Vatsakadi Qwatha
provided significant (P<0.001) change by 38.46% in Fasting Urine Sugar Level after
90 days follow-up period.
4. Effect of Vatsakadi Qwatha on Post Prandial Urine Sugar
Table No: 60 Effect of Vatsakadi Qwatha on Post Prandial Urine Sugar
Mean No. Data
BT AT % S.D S.E T P
1. AT 15 days 0.70 0.60 14.28 0.09 0.07 1.41 <0.05
2. AT 30 days 0.70 0.25 64.28 0.47 0.15 2.85 <0.01
3. AT 45 days 0.70 0.15 85.71 0.25 0.11 5.20 <0.001
4. AFU-90 days 0.70 0.30 57.14 0.35 0.13 2.91 <0.01
Vatsakadi Qwatha provided significant (P<0.05) change by 14.28% in Post
Prandial Urine Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided
mild significant (P<0.02) change by 64.28% in Post Prandial Urine Sugar Level after
30 days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change
by 85.71% in Post Prandial Urine Sugar Level after 45 days of treatment. Vatsakadi
Qwatha provided moderately significant (P<0.01) change by 57.14% in Post Prandial
Urine Sugar Level after 90 days follow-up period.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
4. Effect of Vatsakadi Qwatha on HBA1C
Table No: 61 Effect of Vatsakadi Qwatha on HBA1C
Mean No. Data
BT AT % S.D S.E T P
1. HBA1C 0.70 0.65 7.14 0.15 0.09 0.55 <0.05
Vatsakadi Qwatha provided significant change (P<0.05) by 7.14% in the
objective parameter HBA1C.
5. Effect of Vatsakadi Qwatha on DQOL: Vatsakadi Qwatha provided remarkable compliance with higher Quality Of
Life in Physical (100%), Sexual (90%), Treatment Satisfaction (50%) and in Health
Perception which was remarkably changed in 50% of the subjects from fair to
excellent score even after the follow up period.
Although; good compliance was observed after the duration of treatment in
Psychosocial (50%) and Life Satisfaction (40%) along with the above aspects of
QOL, it showed moderately poor compliance after the Follow Up period.
6. Overall Effect of Vatsakadi Qwatha After 45 days of Treatment.
Table no.62 Overall Effect at 90 days Follow Up period CRITERIA No. of patients Percentage
GOOD RESPONSE 10 50%
MODERATE RESPONSE 04 20%
MILD RESPONSE 04 20%
POOR RESPONSE 02 10%
The overall effect of the investigational product Vatsakadi Qwatha showed good
response in 10 subjects i.e 50%, moderate response in 04 subjects i.e 20%, mild
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
response in 04 subjects i.e 20% and poor response in 02 subjects i.e 10% after 45 days
of treatment period.
7. Overall Effect of Vatsakadi Qwatha After 90 days Follow Up Period
Table no. 63. Overall Effect at 90 days Follow Up period
CRITERIA No. of patients Percentage
GOOD RESPONSE 02 10%
MODERATE RESPONSE 04 20%
MILD RESPONSE 08 40%
POOR RESPONSE 06 30%
The overall effect of the investigational product Vatsakadi Qwatha showed
Good Response in only 02 subject’s i.e 10%, Moderate Response in 04 subjects i.e
20%, Mild Response in 08 subjects i.e 40% and Poor Response in 06 subjects i.e 30%
after 90 days of Follow Up Period.
Chart no.21. Overall Effect of Vatsakadi Qwatha after 45 days of Treatment and
90 days Follow Up period.
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Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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DISCUSSION
The present 21st century has gradually and drastically changed the attitude of
every individuals of the` society towards every aspects of life by guiding and
prompting them towards a weird quality of day to day physical and mental activities
and finally making them to lead an obsessive and erratic lifestyle, which in turn has
led to an health crisis of various lifestyle disorders. One among those topmost lifestyle
disorders is Madhumeha, which has becoming a major health threat in both developed
and developing countries. Although a number of studies had been conducted on
Madhumeha with many formulations, still early diagnosis of this iceberg disease has
found maximum focus in the recent days due to its high incidence as an etiology in
cardiac deaths123, 121.
It also has now become an important outcome of various clinical trials and
health care interventions as the study expectancy has been aimed at reducing the
prevalence and incidence rate of the same with early diagnosis121. At the same time;
timely intervention helps in preventing both short- term and long term complications
which especially has been the long term aim in the treatment of type-2 diabetes126.
The role of psychological factors in triggering the hyperglycemic condition has been
well established based on the HPA axis dysfunction through various stressors- the
disease identity of the present era121. The present study has been selected not only on
the basis of understanding the need of an effective formulation for effective
management of the condition Madhumeha, but also to understand the importance of
Purvarupa especially in this latter condition based on the Vikara Vighata
Bhavaabhava Prativishesha, which is the guiding tool for the early diagnosis of the
same19. So, discussion on the entire study on various observational and statistical
analytical data is summarized here after. The strategy for the discussion is as follows,
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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1. Discussion on Review of Literature.
2. Discussion on Materials and Method.
3. Discussion on Demographic Data.
4. Discussion on Clinical Data.
5. Discussion on Diabetic Quality Of Life.
6. Discussion on Probable Mode of Action of Vatsakadi Qwatha.
DISCUSSION ON REVIEW OF LITERATURE
Discussion on Nirukthi: Literally, the meaning of the words Madhumeha and
Diabetes mellitus have many similarities, where both are used with the sense of
perfuse (watering). Regarding the usage of the term Madhumeha, Acharya
Chakrapani opines that just like a heap of grass, Truna Samuha and a single grass of
particular type Truna Vishesha ; both altogether, can be used with a single term
‘Grass’ similarly the term Madhumeha can be used for all types of Prameha- Sarva
Pramehe and for Madhumeha Visheshe - Vatika Prameha. Here for the present study
it is taken in terms of all types of Prameha not within the paradigm of its counterpart.
Hence, Asadhyata of Madhumeha is justified42, 110.
Discussion on Nidana: Literally and even clinically the extent of importance given
to the role of Nidana in the causation of this condition is well established from both
Ayurvedic and Modern parlance of etiopathogenesis and also the Nidana visheshata
and its role in causing particular extent of Doshic vitiation along with its
corresponding path of vitiating particular Dhatu, mirrors the extent of underlying
Pathophysiology and its clinical manifestation altogether. They highlight the
sedentary lifestyle along with indiscrete usage of food stuffs as the main reason for
the disease. When it comes to the discrete usage of food items especially for this
condition, lot of explanatory theories from Dravyaguna specialty will be supportive
for an Evidence Based Therapeutic and Disease Specific Dietary Approach42, 121.
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Discussion on Purvarupa and Rupa: The Rupa and Purvarupa of Madhumeha are
considered to be similar by Acharya Gangadhara. This is quite similar to the clinical
features of Diabetes Mellitus. But while dealing with symptoms like Karapada Daha
and Karapada Suptata, which are considered as Purvarupa of Prameha in ayurveda21
while Peripheral Vasculopathies and Peripheral Neuropathies which in
concordance with the above are considered as the late complications of Diabetes
Mellitus by the Conventional Medicine121.
The explanatory theory for the above are as follows, Acharya Susrutha has
proposed his theory that all Prameha will attain the state of Madhumeha- Vataja, if
not treated at proper time81. So at the last stage of Prameha, the Purvarupa of
Madhumeha will appear itself as symptoms like Karapada Daha, Karapada
Suptata which is quite in accordance with the late complications of Diabetes Mellitus
but based on Vikara Vighata Bhava Abhava Prativishesha it do not hold good when
the Purvarupa of Sarva Prameha is taken into consideration and is highly liable for
Physicians Cognitive Discretion42. The explanations for the manifestation of the
above along with the other Purvarupa are as follows,
Karapadathala Daha is considered due to Ashayapakarsha Gati of Pita. It
may be also due to loss of Ambu tatva which has Sheeta property and required for
Preenanam, failing of which results in Daha. Another theory from Charakacharya
includes its relationship with the Vata Dosha as explained in the context of Avarana.
Involvement of Rakthavaha Srothodushti is established by this clinical feature
Karapada Daha, based on Asrayaasrayi Bhava between Raktha and Pita90.
The theory of persistent hyperglycemia as the primary mediator for
Endothelial Dysfunction as a result of increased rate of formation of ROS in and
around the tissues is well established as the underlying cause for Peripheral
Vasculopathies121 but, the extent of this pathology depends on the discretion of the
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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predisposing etiological factors inducing or triggering the inflammatory process
within the tissues, which is in accordance with the importance of Vikara Vighata
Bhava Abhava Vishesha principle of Ayurvedic Pathology54.
Karapada Suptata: The Possible Explanatory Theory is; due to
Ashayapakarshaka Gati of Kapha and its relationship with the Vata dosha as
explained in the context of Avarana by Charakacharya90. The theory of accumulation
of AGEs and its effect on the temporory dysfunction of the Peripheral Sensory Nerves
and also its long term effect is suggestive of neurotoxicity from the sustained
hyperglycemic condition is well established121. Eventhough; with all the above
mentioned theories, it is in accordance with the extent and localization of the vitiated
doshas like Kapha and Pita in relationship with the Vata Dosha as explained in the
context of Avarana by Charakacharya and its discretion based on the Vikara Vighata
Bhava Abhava Vishesha decides the prognosis of this clinical feature which in turn
needs lot of explanatory theories in the near future for facing the present Evidence
Based Medicine Era54.
Pipasa Adhikata establishes the Udakavaha Srothodushti and is one among
the cardinal features of Madhumeha which is termed as Polydypsia in Diabetes
Mellitus. The Srotomula of the Udakavaha Srothas is stated as Kloma.
Sharngadhara111 refers Kloma as “thila”. This probably can be referred to Adrenal
Glands which are responsible for the fluid balance of the body. Any disturbance in
the homeostasis of these glands will results in multi systemic dysfunction and one
among which is severe Cellular Dehydration, which may be the reason for Pipasa
Adhikata in Madhumeha. The theory of a very high glucose level causing severe intra
and extra cellular dehydration is well established for the causation of excessive thirst
in Diabetes Mellitus121.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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Mutravaha Srotodushti in Madhumeha is marked by Prabhutamutrata. The
established pathophysiological theory behind this clinical feature is excessive fluid
loss through urination along with glucose causing severe extracellular and to some
extent in the intracellular dehydration resulting in both Polyuria and also Polydypsia
in Diabetes Mellitus120. Prabhutamutrata is due to decreased renal threshold by the
Kidneys brought about by higher glucose concentration of the blood. This leads to
increased Glomerular Filtration Rate (GFR) by the kidneys, which is stated as
Polyuria in Diabetes Mellitus. Another established theory on increased urination is
due to the consequence of osmotic diuresis secondary to the sustained hyperglycemia
during which along with the loss of glucose free water and various electrolytes are
also lost125.
It is “Bahvabadha Medas” and “Bahudrava Sleshma” 112 which are stated to
be important dushya and dosha of Madhumeha. The Srotomula for Medas is given as
Vapavahana113 which may be pointing towards pancreas? but another relative
explanation is towards the Peritoneum / Omentum for Acharya Chakrapani
explanation towards Vapavahana as “Udarasthasnigdhavartika”. The pancreatic
pathology leads to impaired glucose conversion in to triglycerides which is resulting
in the so called Bahvabadha Meda that is in concordance with the harmful LDL
cholesterol.
As far as the Ojus in Madhumeha is concerned it is always the Apara ojus
which is Ardhanjali Pramana which gets disturbed along with the elan vital and the
same circulates all over the body according to the explanatory theory of Acharya
Chakrapani in Arhte Dashamahamuliya Adhyaya48. This disturbance can be inferred
to be initiated right from the time of Nidana Sevena beyond the threshold and then
takes its initiative in bringing about the Dhatusamya Kriya during which it has to
move along with the dosha, and come across Dhatus concerned in bringing about the
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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Purvarupa depending upon Vighata Bhava Abhava Vishesha which in later stage
decides the acquisition of Rupa phase of pathology. From the modern parlance, the
role of T-cell mediated tissue damage in type-2 diabetes mellitus is well established
and it is the T-cell mediated immunity which takes the pivotal role during the
progression of the disease pathology through various stages of inflammation and its
corresponding tissue injury which leads to osmotic changes within the tissues when
glucose concentration in the blood increases. Here possible explanation can be; along
with the body fluid tissue, it is the inflammatory mediators especially Cytokines, the
β-cell agonist which starts circulating all over the body through various systemic
barriers- predominantly Cardiac and Renal125; which hypothetically can be considered
as Kleda, Lasika, Dhatugata mala and vitiated dosha circulating in the blood and
getting excreted out by imparting the Samalatva to the urine along with the Ojus
finally responsible for Avilata of Mutra.
Excessive Kshudha Adhikata is another important symptom which signifies
the Medovaha Srotodushti and thus the pathogenesis established for Sthoulya by
Charakacharya should be considered. This in turn establishes the Avaranata of Kapha
dosha and Medas in relation to the Samana Vata. From the modern parlance, Failure
to use glucose for energy leads to increased utilization and decreased storage of
proteins as well as fat. Therefore, a person with severe untreated Diabetes Mellitus
suffers rapid weight loss and asthenia (lack of energy) despite eating large amounts of
food Polyphagia. Without treatment, these metabolic abnormalities can cause severe
wasting of the body tissues and death within a few weeks125.
Another important characteristic feature of the disease is Swedapravruthi.
The Abadhamedas along with the vitiated Kapha Dosha, its Vishyandatva, Gurutat,
Bahutvat and Vyayama Asahatvat is responsible for excessive Swedapravruthi.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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Dourbalya is another signicant clinical feature of Madhumeha which has
gained more focus especially from all streams of medicine in recent days and the
explanation is Asamatvat Dhatunam according to Charakacharya and established
theory from the modern parlance is; due to the increased insulin resistance in type-2
Diabetes Mellitus, the tissues fail to even utilize the available glucose and the
peripheral tissues especially muscle tissue etc suffer then, as a result, it draws energy
from the available fat tissue and also the proteins and finally causes asthenia or lack
of energy or Dourbalya125.
Atinidra and Atithandra- these are the significant clinical features which are
suggestive of vitiated state of Dhatu which decides the Pranashrita ojo dushti. ANS
dysfunction is a well established theory in uncontrolled hyperglycemic condition.
Another theory established clinically is the subjects's level of consciousness varies
depending upon the degree of Hyperosmolality125.
Discussions on Samprapti: The most important concept in the vicious cycle of
pathology of Madhumeha is the significance of the Prakruta Kapha as Ojas which gets
disturbed and altered from Badhata to Abadhata48, 90.
The Dushyas included are Meda, Mamsa, Sharira Kleda, Shukra, Shonita,
Vasa, Majja, Lasika, Rasa and Oja. The special characteristic features of these
Dushyas are in Bahvabadha form which is highly liable for physician’s cognitive
discretion90. From the modern parlance the following pathophysiological theories in
relationship with the type -2 Diabetes Mellitus are well established121, 125.
1. Impaired Lipoprotein Metabolism.
2. Endothelial Dysfunction.
3. Pro thrombotic state.
4. Atherogenic factor.
5. Inflammation.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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These pathological theories are invariably supportive for the condition termed as
Metabolic Syndrome or Syndrome X which is now considered as the changing trend
of Diabetes Mellitus into a cardiovascular disorder125.
The above explanatory theories highlights the importance Rasa Dhatu and Rakta
Dhatu and the srotas concerned which are the core substratum for the progression of
the disease pathology and its complications in its later stages.
Discussion on Upadrava: The esteemed emeritus foresight of the Ayurvedic seers
over the Upadrava of this condition Madhumeha enlisted approximately thousand
years ago36, identified and named as Diabetic Carbuncles are now well justified with
various explanatory theories based on the Altered Platelet Function along with the
Coagulating and Fibrinolytic factors, Endothelial Dysfunction and increased
Oxidative Stress121, 125. Recent DCCT studies reveal that these altered functions with
varied degree can manifest both in the early as well as in the advanced stage of this
condition but commonly noticed diabetic complications are CAD, diabetic
nephropathy and diabetic retinopathy. The above mentioned DCCT study also
highlights the importance of importance of Vikara Vighata Bhava Abhava
Prativishesha even at the stage and site of causation and clinical manifestation of
these complications termed as Pidakas which later leads to a clinical condition termed
as Putipuyamamsa - Diabetic Gangrene. Pipasa, Arochaka, Avipaka, Atisara and
Vrushanayoravadaranam are few systemic complications mentioned in Ayurveda36.
Discussion on Sadhyasadhyatha: Diabetes is not a curable disease; the treatment
Strategy is to enable subjects to lead lives Similar to those of healthy persons, while
preventing complications through appropriate Treatment and Personal Management.
To achieve this objective, it is important to reduce Psychological, Physical, and
Lifestyle Burdens and Restrictions due to diabetes as much as possible. So,
evaluation of Health-Related Quality Of Life (HRQL) is of more important for
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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evaluating the burden on subjects and in selecting treatment methods. Health Related
Quality of Life measurement provides a comprehensive evaluation of the subjects’s
health status which would provide additional information to laboratory data and also
with the subjective symptoms which in turn highlights the importance and global
implementation of Dinacharya, Rtucharya and discrete utilization of classical
formulations with drug specifications and supportive evidence based explanatory
theories for the same thus meeting the required standards of care globally. Based on
Vikara Vighata Bhava Abhava Prativishesha48, 54, it is still under the sacred healing art
of Avastha Vishesha Chikitsa Jnana of Vedic Medicine which can provide effective
standards of Diabetic Care and Prognosis which in turn is highly liable for Physician’s
Cognitive Discretion90.
Discussion on Arishtalakshana: Severe persistent hyperglycemic condition leads to
cell destruction with restricted elimination of the toxins causing fruity odour125; which
attracts flies even after the bath of the subjects which in turn is a sure prognostic sign
of death mentioned for Prameha68, 69. The fruity breath odor of acetone further
suggests the diagnosis of Diabetic Ketoacidosis125. This extensive hyperglycemic
condition may produce diabetic coma and lead to death125.
1. Discussion on Materials and Methods
Discussion on Selection of Polyherbal formulation: The selection of Polyherbal
formulation was based on the following considerations,
a) The formulation should contain more potent ingredients.
b) The ingredients should have more disease specific action on Madhumeha and
dosha specific action with Mehagna property.
c) The ingredients of the formulation should be cost effective and it should be
easily available with minimum controversies.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)
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The formulation Vatsakadi Qwatha mentioned in Sharangadhara Samhita fulfilled
the above considerations and hence selected for present clinical study.
Discussion on Posology: The dose of the Polyherbal formulation is fixed as 50ml in
divided dose twice daily 15 min before food with equal quantity of Luke Warm Water
keeping in view that dose specification of Qwatha Kalpana is fixed to be as 2 Pala
per day by Acharya Sharangadhara110.
Discussion on Inclusive Criteria:
1. The subjects with Prabhutamutrata, Avilamutrata, along with other classical
symptoms and signs with Pipasa Adhikata, Kshudha Adhikata, Karapada Daha,
Karapada Suptata, Swedapravruthi and Dourbalya is included since these are the
cardinal features of the disease48.
2. Age group between 25-60yrs of either sex is included for the study. MODY affects
individuals <25 yrs and recent DCCT study reveals the occurrence of diabetes is now
considered more in middle aged persons due to growing erratic change in lifestyles.
This is the reason for fixing the age range as described above123.
3. The Fasting Blood Glucose Level ranging from 126mg/dL-180dL, Post Prandial
Blood Sugar level ranging from 160mg/dl-250mg/dl is selected considering the
limitations of the present study. This is based on the W.H.O approved diagnostic
criteria for Diabetes Mellitus123.
Discussion on Exclusion Criteria:
1. Age groups above 60 yrs and below 25yrs are avoided. In subjects above 60 years
the response of the medicine will be considerably below the expected due to
increased percentage of catabolic activity along with the possible disease
chronicity125. Subjects below 25 yrs avoided on the basis of the recent DCCT study
revealing MODY onset is <25 yrs. PPBS level more than 250mg/dl is avoided
considering the chronicity of the disease and limitations of the present study123.
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2. Subjects suffering with systemic ailments like Renal Disorder, Cardiac disorder etc.
is excluded since they need critical care and continuous monitoring. Sahaja and
Jathaja Madhumeha w.s.r to MODY and other genetically predisposed diabetic
conditions are excluded considering the limitations of the present study123.
3. Subjects with diabetic gangrene, carbuncles and other diabetic complications are
excluded considering the limitation of available clinical data and supportive
explanatory theories on the Polyherbal formulation for its condition specific
implementation.
Discussion on Diagnostic Criteria: The diagnosis depends on the classical
symptoms like Prabhutamutrata, Avilamutrata, Pipasa Adhikata, Kshudha Adhikata
along with other classical symptoms etc. and laboratory work up on Fasting Blood
Sugar level ≥126 mg/dl and Post Prandial Blood Sugar level ≥200 mg/dl based on
the W.H.O proposed diagnostic criteria for Diabetes Mellitus 2009123, 125.
WHO approved diagnostic criteria strictly recommends that
Glycated/Glycosalated hemoglobin, HBA1C should not be used for diagnostic
purpose. Here in the present study HBA1C was carried out before the treatment and
after 90 follow up period for assessing the pre and post – therapeutic effect of the
Polyherbal formulation -Vatsakadi Qwatha over the long term glycemic control of the
subjects. HBA1C as an objective parameter has gained maximum focus due to
peaking incidence of undiagnosed and untreated diabetic subjects; but should be
reconsidered based on its availability and cost, for the future studies125.
Discussion on Assessment criteria: Assessment on symptoms of Prabhutamutrata
(increased amount and frequency of micturition), Avilamutrata, Pipasa Adhikata,
Kshudha Adhikata, Swedapravruthi, Karapada Daha, Karapada Suptata, Dourbalya
and laboratory investigations like Fasting Blood Sugar, Post Prandial Blood Sugar,
fasting urine sugar and Post Prandial urine sugar has been done according to the self
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assessment criteria based on their normal values with grading ranges from 0-3.This
has been done for statistical analytical purpose.
Discussion on drop outs: In the present study, 30 subjects were screened and
diagnosed for Madhumeha in the conducted medical camp, out of which 5 subjects
were excluded from the study based on exclusion criteria. Among the remaining 25
subjects, 20 subjects satisfying the inclusion criteria was been taken for statistical
analysis, 5 subjects among whom 3 subjects had discontinued the treatment due to
transportation inconvenience and 2 subjects failed to attend the subsequent first
follow up without any reason and were considered as drop outs of the study. The
issue on Palatability of the Polyherbal formulation was absolutely nil among 20
subjects who were included for the present study.
3. Discussion on observations related to demographic data
1. Age: Among the 20 subjects; majority of the subjects were distributed primarily
between the age ranges of 41 - 45yrs and secondarily between the age range of 36 –
40, 51 - 55 and 56 – 60 years which clearly highlights the WHO data of age
occurrence of type -2 Diabetes Mellitus. The possible explanatory theory is due to in
discreet day-to-day physical and mental activity sufficient enough not to burn away
the hypercaloric diet along with the accelerated rate of catabolic activity due to the
disease identity of the present era – Stress which significantly affects the process of
ageing121.
2. Sex: Majority of the subjects were Females (75%) in the present study.
Hypothetically; due to their inevitable, indiscrete and unorganized day-to-day
physical and mental activities along with erratic dietary habits including untimely and
junk food stuffs121 which is evident within the age criteria.
3. Religion: Majority were Hindus. It is due to the Hindu dominated study site.
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4. Educational qualifications: Majority of the subjects was graduated which is
highly supportive for the awareness required for their progressive health plans and its
positive outcome for leading a better quality and standards of diabetic life.
5. Marital status: About 85% of subjects were married. Post marital life without
organization in their day-to-day physical and mental activities along with erratic
dietary lifestyle is quite suggestive of the disease entity of present era – Stress121, 125.
6. Occupation: Majority of the subjects were Homemakers (55%) which highlights
the indiscrete day-to-day physical and mental activities with erratic dietary lifestyle.
7. Habitat: Majority belongs to rural habitat, which supports the DCCT results with
lack of required amount of discrete physical and mental activity for optimum
utilization of the available quality of food stuffs.
8. Socioeconomic status: About 70% of the subjects belonged to Middle Income
Group, which is quite favorable with the disease identity of present era.
9. Desapradhanatha: 80% of subjects belonged to Anupa Desa, which is further
favorable for the vitiation of Kapha Dosha especially in those with sedentary
lifestyle48.
4. Discussion on data related to Subjects Clinical Findings
1) Discussion on main presenting complaints of the subjects: Although; majority
of the subjects presented with Dourbalya (100%) along with Karapada Daha (95%) as
the common presenting complaint, it was Pruritis Vulvae which presented in almost
10 female subjects along with Dourbalya and Karapada Daha which is quite
suggestive of typical clinical presentation found in type-2 female diabetic subjects125.
2) Discussions on personal history of the subjects:
a) Discussion on data related to dietary regimen: Untimely Vegetarian Diet (55%)
dominated Untimely Mixed Diet (45%) which is quite supportive for the progression
of the underlying pathology. Hence as a part of drug specification; and also as a
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dietary and lifestyle modification, subjects were reinforced for taking timely, fibrous
rich, vegetarian diet with complete abstinence from untimely, non vegetarian, and
spicy food stuffs121,122.
b) Discussion on data related to supplementary diet: Subjects who had coffee and
tea as major supplementary diet were more affected (50% and 40% respectively). The
established theory is that caffeine present in the coffee and tea are potent enough to
trigger and accelerate the rate of inflammation and thus the tissue injury caused due to
persistent hyperglycemic condition which is also supportive for reduced insulin
sensitivity and increased insulin resistance. As a part of drug and disease specification
it was strictly advised for a regulated dose of these beverages while chats, soft drinks
were completely restrained from the subject’s dietary regimen.
c) Discussion on data related to Vyasana: Five of the female subjects were reported
to have habit of pan chewing and 02 male subjects were reported to have the habit of
cigarette smoking which is known for amplifying inflammation via AGEs121, 122.
d) Discussion on data related to Agni and Koshta: Vishamagni and Mandagni were
observed in maximum number of subjects which clearly indicates the status of Krura
and Madhyama Koshta in relation with the dosha and its extent of vitiation in causing
the clinical manifestation of Purvarupa in Madhumeha subjects based on Vikara
Vighata Bhava Abhava Prativishesha48.
e) Discussion on data related to Stress: 50% of the subjects revealed disturbed sleep
which contributes for the HPA axis dysfunction. At the same time 85 % of the
subjects were observed to have Madhyama satva and 15% with Avara satva which is
quite supportive for susceptibility to Peak Stress Crisis and the subsequent episodes of
persistent hyperglycemic condition leading to Immune suppression121, 122.
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3) Discussion on data related to Systemic effect:
a) BODY MASS INDEX: Majority of the subjects came under the paradigm of
normal range while two were under over weight and another was within the obese
range. This in turn highlights the presence of possible Mild Hypertensive condition
and also Atherosclerotic Vascular Changes as established in updated version of
CMDT 2009125.
b) EVIDENCE OF INSULIN RESISTANCE: The signs of dehydration like dry
flaky skin and Acanthosis Nigricans are quite suggestive of Udakavaha and
Mamsavaha Srotodushti which in turn can be considered as the evidence of
underlying insulin resistance and was observed only in few subjects.
4) Discussion on data related to Prakruthi: In the present study; Vatakapha Prakruti
(35%) showed maximum tendency of getting Madhumeha and subsequently by
Kaphapitha and Vatapita Prakruti for about 25% each. The disturbed state of Ambu
Tatva of Kapha, Agneya tatva of Pita and Yogavahi Tatva of Vata altogether or in
combination with one another plays a vital amplifying role in the successive
progression of vicious cycle of pathology at various levels with varied degree within
the Dhatu in Madhumeha.
5) Discussion on data related to Vikruthi: The observation on Vikruthi showed
significant involvement of Rasa (100%), Medas (100%), Rakta (85%), Mamsa (90%),
and Shukra (45%) Dhatu’s respectively. This clearly signifies the affliction of
respective Avaraka Dosha- Kapha and Pita predominantly and Vata in corresponding
Dhatu in varied degree. Based on Ashrayaashrayi Bhava and Vikara Vighata Bhava
Abhava Prativishesha; the Vikruthi in all the subjects’ falls within the paradigm of
Madhyama and Avara.
6) Discussion on data related to Nidana: The observation on Nidana revealed
important factors like untimely food habits – Carbohydrate, Fat rich diet, excessive
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junk foods, spicy non vegetarian diet (100%), indiscrete aimless physical activities
(100%) along with enough worthless worries, anger, grief and frustrations and
emotional breakdowns (100%) responsible enough to initiate and amplify the vicious
cycle of pathology of the disease Madhumeha, both from the ayurveda and modern
parlance.
7) Discussion on data related to Dhatu involved symptoms: Alasya;
Procrastination, a Rasa Dhatu involved symptom is observed in 100% of the subjects
is suggestive of impaired Dhatvagni –process of tissue metabolism in Madhumeha.
Swedapravruthi and Dourbalya are suggestive of Medo Dhatu involvement in
Madhumeha. Karapada Daha and Karapada Suptata are suggestive of Rakta Dhatu
and its Upadhatu involvement.
5. DISCUSSION ON DIABETIC QUALITY OF LIFE
Although; Quality of life is a subjective and complicated experience which is
widely used as an indicator in different recent clinical trials and descriptive studies on
either types of Diabetes Mellitus, here only Selective and relevant Questions from the
WHO approved and DCCT validated Questions in relation with the clinical findings
related to type-2 were adopted for assessing and scoring of Diabetic Quality Of Life.
Various recent DCCT studies on DQOL have revealed that there seems to have a
negligible relationship between QOL and age or duration of diabetes but it is the
physical signs and symptoms which have shown a remarkable relationship with the
QOL of the diabetic subjects.
As per the recent objectives proposed by WHO on diabetics patient care; all
the subjects were sufficiently co-operative for assessing the diabetic quality of life
which revealed a remarkable compliance with higher QOL in Physical (100%),
Sexual (90%), Treatment Satisfaction (50%) and in Health Perception which was
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changed in 50% of the subjects from fair to excellent score even after the follow up
period. The possible explanation for these findings is that firstly; majority of subjects
were new patients having diagnosed DM < 3 years with no complications and on no
Oral Hypoglycemic Agents Secondly, significant relief in the subjective parameters
especially of Dourbalya (P<0.001) even after follow up period. Although; good
compliance was observed after the duration of treatment in Psychosocial (50%) and
Life Satisfaction (40%) along with the above aspects of QOL, it showed fair
compliance after the follow up period.
6. PROBABLE MODE OF ACTION OF VATSAKADI QWATHA
Considering the findings based on the Vikara Vighata Bhava Abhava
Prativishesha; the probable mode of action of the Polyherbal formulation–Vatsakadi
Qwatha can be analyzed based on the involvement of respective Dosha, Dushya,
Sanga and Atipravruti type of Srotodushti and Agni, as the main pillars of discussion.
The possible explanatory theories supporting the probable mode of action of
the Polyherbal formulation- Vatsakadi Qwatha used for the present study are
discussed hereafter based on the following headings,
1. Probable mode of action on assessment Criteria’s.
2. Based on the theory of Rasa Panchaka.
3. Based on Recent Drug Research.
4. Based on Phytochemical analysis.
1. PROBABLE MODE OF ACTION OF VATSAKADI QWATHA ON
SUBJECTIVE PARAMETERS
a. Mode of action on Prabhutamutrata: The possible explanatory theory; Kapha
Pita Kleda Upashoshana Kriya of Vatsaka and Mala Shodhana effect of Triphala,
Daruharidra, Musta and Bijaka might possibly have helped in regulating the
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amount and frequency of micturition which on the other side might support the theory
of inhibiting inflammation induced excessive cellular dehydration caused due to
persistent hyperglycemic condition120, 121, 122.
b. Mode of action on Avilamutrata: The possible explanatory theory; Amapachana,
Vatanulomana Kriya, Mala Shodhana, and Kaphapita Nashaka Kriya of Triphala,
Dosha Pachana Kriya of Daruharidra, Rasayana Kriya of all the drugs might
possibly have helped in rectifying the Samalatva of Mutra to Nirmalatva which on the
other side might support the theory of glycemic control through restricting the
formation of AGEs and its timely evacuation from the body121, 122.
c. Mode of action on Pipasa Adhikata: The possible explanatory theory; Trushna
Nigrahana Kriya of Musta and the Qwatha Kalpana might have possibly helped in
regulating the above symptom which on the other side supports the theory of
regulating the fluid and electrolytic balance by inhibiting inflammation induced
excessive cellular dehydration and subsequent fluid and electrolyte loss caused due to
persistent hyperglycemic condition120, 121, 122.
d. Mode of action on Kshudha Adhikata: The possible explanatory theory;
Amapachana, Kaphapita dosha Shamana, Medohara Kriya of Musta, Bijaka,
Daruharidra along with Vatanulomana Kriya of Triphala might possibly have
helped in removing the Avarana between Vata Dosha and Medo Dhatu thereby
rectifying Kshudha Adhikata, which on the other side might support the theory of
regulating the Hepatic and Intestinal Metabolic Activity122.
e. Mode of action on Karapada Daha: The possible explanatory theory is Kleda
Upashoshana Kriya of Vatsaka, Amapachana, Kaphapita dosha Shamana,
Vatanulomana Kriya of Triphala along with Rasayana Kriya might have helped in
bringing back the Dosha - Pitakapha to their normal site and perform normal
physiological function thereby rectifying Karapada Daha which on the other side
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might support the theory of reducing the persistent hyperglycemic condition induced
Tissue Injury and the subsequent Endothelial Dysfunction121,122.
f. Mode of action on Karapada Suptata: The possible explanatory theory is Kleda
Upashoshana Kriya of Vatsaka, Amapachana, Kaphapita dosha Shamana,
Vatanulomana Kriya of Triphala along with Rasayana Kriya might have helped in
bringing back the Dosha – Kaphapita to their normal site and perform normal
physiological function thereby rectifying Karapada suptata which on the other side
might support the theory of reducing the persistent hyperglycemic condition induced
ROS formation and its subsequent Neurotoxicity121.
g. Mode of action on Dourbalya: The possible explanatory theory ; Agni Deepana,
Amapachana, Srotoshodhana, Malashodhana, Srotoshudhi, Malashudhi and Rasayana
Kriya of all the drugs in the Polyherbal formulation might possibly have helped in
rectifying Dourbalya which on the other side might support the theory of multi
systemic and synergistic anti-inflammatory and anti hyperglycemic action of all the
drugs in the Polyherbal formulation promoting enhanced insulin sensitivity and
reduced insulin resistance, most importantly enhancing the hepatic uptake of glucose
and subsequent process of Glyconeogenesis followed by proper utilization of glucose
by the peripheral tissue121,122.
h. Mode of action on Swedapravruthi: The possible explanatory theories are Agni
Deepana, Amapachana, Kleda Upashoshana along with Srotoshodhana, Medohara
and Rasayana Kriya of all the drugs in the Polyherbal formulation might possibly
have helped in reducing the Adhika Sweda Pravruthi which on the other side might
possibly support the theory of reduced Lipid Peroxidation especially within the
liver122.
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OBJECTIVE PARAMETERS:
a. EFFECT ON FASTING BLOOD SUGAR LEVEL: It signifies the enhanced process
of hepatic gluconeogenesis which is hampered due to persistent hyperglycemic level.
b. EFFECT ON POST PRANDIAL BLOOD SUGAR LEVEL: It signifies the process
of glucose uptake by the peripheral tissues especially skeletal muscles induced by
reduced insulin resistance.
c. EFFECT ON FASTING URINE SUGAR: It signifies the reduction in the renal
threshold..
d. EFFECT ON POST PRANDIAL URINE SUGAR: It also signifies the glycemic
control especially enhanced insulin sensitivity and reduced insulin resistance in the
peripheral tissues.
e. EFFECT ON HBA1C: Although not much change was observed after the follow up
period it still signifies the accummulation of AGEs along with a long term glucose
control.
2. BASED ON THEORY OF RASA PANCHAKA
a) Probable mode of action based on the Rasa: If we analyze the percentage of
Rasa –Inspite of the presence of Lavanavarjita Pacharasa Yukta Oshadhi Dravya like
Amalaki and Haritaki the formulation is dominated by Kashaya. Tikta and Katu
Rasa’s because of the presence of Vatsaka, Daruharidra, Musta and Bijaka. From the
above criteria, it is evident that Kaphapita Nashaka Kriya and Vata Shamana Kriya
are possible from this Polyherbal formulation. So; Vatsakadi Qwatha is potent enough
to bring back Prakupita Kaphapita Dosha, which is responsible for Margavarana of
the vata dosha to its balanced state and thus breaking the vicious cycle of
pathogenesis of the disease Madhumeha. At the same time, it nullifies the effect of
the toxic exposure of the Dhatu’s to the same and promotes restoration.
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b) Probable mode of action based on Guna: It is nothing short of a miracle that all
the drugs in the Polyherbal formulation- Vatsakadi Qwatha are possessing Laghu and
Ruksha Guna in common but liable for discretion regarding its extent. However; the
criteria is quite supportive for the required Ulekhana action for Srotoshudhi, which in
turn provides Medohara, Kaphahara and Lina dosha Nashaka effect altogether.
c) Probable mode of action based on Virya: The drugs in the Polyherbal
formulation- Vatsakadi Qwatha possess Ushna and Sheeta Virya in the ratio 4:3,
which is quite supportive for not only for the reduction of Kleda an Lasika but also for
maintaining the normal homeostatic nature of vata dosha by amplifying Tridoshahara
and Medohara effect and thus break up the vicious cycle of pathology of the disease
Madhumeha. At the same time, it promotes the formation of Prashasta Dosha, Dhatu
and thus restores Dhatu Samyatva.
d) Probable mode of action based on Vipaka: The drugs in the Polyherbal
formulation- Vatsakadi Qwatha possess Madhura and Katu Vipaka in the ratio 3:3,
which is quite supportive for promoting and restoring the normal functions of the
damaged Dhatu by nullifying and rejuvenating the Dhatu from the effect of Prakupita
Dosha and thus restore Dhatu Samyatva.
e) Probable mode of action based on Karma: The drugs in the Polyherbal
formulation- Vatsakadi Qwatha possess Kaphapitahara and Tridoshahara activity in
the ratio 5:2 and also with Kledopashoshana, Sangrahi, Jvaragna, Medohara, Mutrala,
Chakshushya, Trushnanigrahana, Kandugna, Kushtagna, Stanya Shodaka,
Virechnopaga, Rasayana and Vajeekarana activities altogether responsible for
restoration of Dhatu Samyatva.
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3. BASED ON RECENT DRUG RESEARCH124
As already mentioned in the introductory section of this study; there are few drugs in
the Polyherbal formulation- Vatsakadi Qwatha, which are proven to have
hypoglycemic effect and are also on the verge of proving various other biological
effect over the human body. They are,
1. Vatsaka: Anti-Oxidant, Anti-Bacterial, Anti-Inflammatory, Anti-Viral and Anti
Diarrheal – these actions might possibly have helped in overcoming the process of
pathological cycle within the intestines by reducing the inflammatory tissue response
and regulating the absorptive nature of the intestinal bacterial flora by strengthening
and toning up the intestinal walls by timely evacuation of AGEs from the system122,
which correlates with the theory of Charakacharya - Kapharaktapitasangrahana Tatha
Upashoshananam Kutaja Tvak – liable for physician’s cognitive discretion104. This
also supports for the pacification of Pruritis vulvae and generalized body itching –
Hepatoprotective action on the verge to be established122, 124.
2. Triphala: Anti-Oxidant, Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory,
Hepatoprotective, Cardioprotective and Anti-Diabetic activity of Haritaki, Amalaki
and Vibhitaki with carbohydrate rich content are potent enough to reduce the vicious
cycle of pathology by timely evacuation of AGEs from the blood stream and β-cell
stimulation. In coordination with the other drugs it reduces the insulin resistance and
increases the insulin sensitivity of the peripheral tissues by stimulating Adiponectin, a
potent Insulin Sensitizer122, 124. The above description can be justified with the
following reference ||Triphala Kapha Pitagni Mehakushtahara Apara | Chakshushya
Dipani Vrushya Vishama Jvara Nashini ||104
3. Daruharidra - Anti-Oxidant, Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory,
Hepatic Stimulant, Hepatoprotective, Anti-Ulcerogenic, Anti-Adhesive Anti-
Bacterial, Anti-Platelet Aggregation and Anti-Diabetic activity; mimics Anti-Septic
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and Anti Pruritic on the verge for its establishment altogether promotes glycemic
control right from correcting the Cardiohepatic – due to Anti-Arrhythmic effect and
protects hepatocellular damage due to persistent hyperglycemic state, Cardiorenal
systemic dysfunction synergistically122, 124..
4. Musta- Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory, Hepatic Stimulant,
Hepatoprotective, diuretic activities which are already established – are supportive
enough to bring about the glycemic control by correcting the cellular dehydration and
osmotic diuresis121,122, 124.
5. Bijaka- Anti-Hyperglycemic, Anti- Hyperlipidemic, Cardiotonic,
Hepatoprotective, Anti Oxidant, Anti Inflammatory, insulin- like activities are quite
supportive for glycemic control and reduction in common symptoms of Diabetes
Mellitus through correcting the pathway of insulin by protecting and restoring the β-
cell function, reducing the inflammatory tissue response by inhibiting the
prostaglandin and COX-2 inhibiting activity, also protecting the hepatocellular
damage122, 124.
Also recent study entitled “Effect of Triphala in pancreatitis for β cell
restoration” is really encouraging for the life science professionals for having an
upper hand for the better standards of diabetic care in the near future.
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4. BASED ON PHYTOCHEMICAL ANALYSIS
The Phytochemical and qualitative study result and its relevance are as follows,
1. The Acidic pH value in this Polyherbal formulation Vatsakadi Qwatha
– amplifies the rate of absorption of the drug within the Stomach, Upper gastro
intestinal tract thus rendering better bioavailability in the intestines.
2. The Specific Gravity of Vatakadi Qwatha- 1037 – which might possibly
have supported in better absorption of the drug.
Carbohydrates –present in this Polyherbal formulation Vatsakadi Qwatha.Plant
energy storage components are referred to as carbohydrates. Plant starch, gums,
mucilage, cellulose are all Polysaccharides. These along with their derivatives are
known to exert a beneficial action on the body's immune system, increasing in
strength, whose derivatives have been developed as bulking agents for the alleviation
of constipation and as agents meant to reduce the appetite
(Ref - Tyler et.al.44-45).
Bitter Tannins - These bitter tannins along with the Anthroquinone glycosides in
Vatsaka, Triphala etc. are known for their Anti-hyperglycemic, Anti-inflammatory,
Anti-diarrheal, Anti-viral, Antiparasitic, Anti-allergic, Anti-thrombotic and
Vasoprotective properties. These plant constituents exert antioxidant effects on free
radicals in the body – (Ref - Plant Material Medica and Harborne and Baxter, 84).
Alkaloids - Alkaloids like Conessine in Vatsaka for Anti Inflammatory, Anti Oxidant
and Vaso protective action – Chemistry of Natural Compounds. Vol.35, 1999,
Berberine in Daruharidra, Epicatechin in Bijaka etc is known for their Anti-
hyperglycemic, anti-lipidemic, Hepatoprotective action –(Ref- Dukes Phytochemical
And Ethnobotanical Database).
Saponins – Sesquiterpenoids, Terpenoid Saponins in Musta for Anti Inflammatory,
Anti Pyretic, Hepatoprotective and Anti lipidemic action and also for have been used
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to stimulate actions within the body such as mucosal or gastric secretion, as an
antibiotic, antiviral, and bitter tonic – DeFeudis, 1991; Harborne and Baxter,
PD2447; Petkov et al., 106).
Steroidal Saponins – Pterostilbene in Bijaka is proven to be Cardiotonic and
Hepatoprotective - Harborne and Baxter, 689.
Phytosterols – These are necessary plant membranes and plant cell growths. B-
Sitosterol decreases the risk of atherosclerosis by lowering plasma concentrations of
LDL's (low-density lipoproteins) - Lehninger, 614.
Phenolic and Flavanoid compounds - These are known to be beneficial as powerful
Antioxidants, Stress Modifiers, Anti-Allergic agents, Anti-Viral compounds and Anti-
Carcinogens - Evans, 420. Some are able to stimulate protein synthesis, and some are
known Anti Inflammatory agents. Still others have demonstrated Vaso-protective
activity. Some are Diuretic, Antispasmodic, Antibacterial, and Antifungal - Harborne
and Baxter, 367-415.
All the above Chemical Compounds and proposed pharmacokinetic activity present in
Vatsakadi Qwatha supports and fulfills the recent pharmacological invention related
to a herbal composition for the treatment of Diabetic Mellitus and Metabolic
Syndrome where in one of its embodiment; the invention provides a composition
comprising of anti hypoglycemic agent, anti inflammatory agent, anti hyperlipidemic
agent, anti oxidant agent and a gastro intestinal agent with at least one of these agents
being derived from a plant while, Vatsakadi Qwatha completely satisfies with all
from the plant source itself.
All the above theories related to the drug review fulfills the purpose of
bringing about synergistic action by the Polyherbal Formulation-Vatsakadi Qwatha
and thus potent enough to break the vicious cycle of pathogenesis – Samprapti
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Vighatana in Global Systemic Illness like Madhumeha vis a vis type-2 Diabetes
Mellitus.
MERITS AND DEMERITS OF THE POLYHERBAL FORMULATION
VATSAKADI QWATHA
The following are the merits and demerits of the Polyherbal formulation – Vatsakadi
Qwatha selected for the present study.
MERITS:
1. A potent Polyherbal formulation for the management of Madhumeha w.s.r to
diabetes mellitus (NIDDM).
2. All the drugs are easily available.
3. Palatability was satisfactory.
4. It has proved better effect in controlling glucose level in diabetics without any
adverse events in the present study.
DEMERITS:
1. It is costlier comparatively.
2. Portability was another demerit noticed in the present study.
3. Long term administration of the drug is still questionable due to Lack of
sufficient clinical data.
4. Long term storage of this Qwatha is a problem.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
CONCLUSION
After critical analysis and systematic clinical work, the following conclusions can be
drawn on the action of formulation Vatsakadi Qwatha on Madhumeha.
1. The disease review reveals lot of similarities between Madhumeha and Diabetes
Mellitus and importance of Purvarupa of the disease extending into its Rupa phase is
well established based on the emeritus concept of Vikara Vighata Bhava Abhava
Prativishesha.
2. Observation reveals those individuals who are accustomed to indiscrete physical and
mental activities along with erratic dietary regimen especially in middle aged house
wives showed maximum susceptibility for the disease Madhumeha.
3. The clinical trial of Vatsakadi Qwatha showed significant reduction in all the clinical
features, in particularly Dourbalya, Karapada Daha and Pipasa Adhikata reduced
predominantly followed Prabhuthamutratha, Kshuda Adhikata, Swedapravruthi,
Avilamutrata after 45 days of treatment period. After 90 days follow up period
showed less significant in all the subjective parameters, except in Dourbalya.
4. The clinical trial and assessment reveals the formulation successfully reduced FBS,
PPBS, and Urine sugar levels within a short period of the treatment which signifies
role of glycemic control by the Polyherbal formulation – Vatsakadi Qwatha.
5. Observation on Glycated hemoglobin – HBA1C was not changed markedly with
respect to pre and post test design.
6. Overall effect reveals that, the formulation is highly significant during treatment
period of 45 days. So it justifies the alternate hypothesis during the treatment period.
‐ 164
7. The formulation showed insignificant result during the follow up period i.e 90 days of
observation without medication. So it substantiates the null hypothesis after the follow
up period.
‐
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
8. The formulation did not show any adverse events either during the treatment period or
during the follow up period. So this is suggestive that the drug Vatsakadi qwatha is an
effective as well as an ideal drug for effective management of the disease Madhumeha
w.s.r to Diabetes Mellitus (NIDDM).
SCOPE OF FURTHER STUDY:
1. As the study was conducted over a small sample, a similar study performed over a
large sample for a longer period would have procured much sharper and accurate
results.
2. Comparative studies may provide the required specification for the formulation.
3. Efficacy of the drug should be checked in type-1 and also in diabetic complications.
4. The effect of the drug along with Shodhana therapy should be critically analysed.
5. The efficacy of formulation in Ghana Vati Kalpana should be checked.
6. To appreciate any positive changes with respect to the HBA1C, it would be ideal to
administer the drug for more than 4 months.
‐ 165 ‐
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
SUMMARY
The present study entitled “CLINICAL EVALUATION OF VATSAKADI
QWATHA IN THE MANAGEMENT OF MADHUMEHA WITH SPECIAL
REFERENCE TO DIABETES MELLITUS (NIDDM)” comprises of different
topics discussed under the following headings.
1. Introduction: This section deals about Multi-Dimensional Ayurvedic Perception
towards the health, disease and therapeutics; brief analysis of the historical
background of the disease Madhumeha, its present status in 21stcentury with
prevalence and incidence of the disease Madhumeha among world population.
2. Objectives: This section deals with the main aims and objectives of the present
study along with the Null and Alternate Hypothesis.
3. Review of Literature: This section deal with the collection of data regarding
Etymology, Definition, Classification, Nidana, Purvarupa, Rupa, Samprapti,
Sadhyasadhyata, Upadravas, Arishta Lakshanas and Chikitsa along with Pathyapathya
of the disease Madhumeha. This section also deals with the modern conception
towards the disease Diabetes Mellitus: its Clinical information, Diagnostic Criteria
approved by WHO and its related therapeutic information.
4. Methodology: This section deals with the detailed description of clinical study
with respect to Subject Grouping, Selection, Inclusion and Exclusion Criteria,
Treatment Protocol, Duration of the Treatment, Assessment Criteria for both
Subjective and Objective Parameters along with Diabetic Quality of life
questionnaire, Overall Assessment Criteria and Study Design of the present study.
- -
166
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
5. Results: This section deals with the result obtained after completion of 45 days of
Treatment and 90 days of Follow Up period. The scoring of Subjective and Objective
Parameters of Madhumeha before and after treatment are statistically tabulated and
percentage of response is calculated and analyzed using student paired‘t’ test. The
total relief obtained after the treatment schedule was recorded as-
i) GOOD RESPONSE.
ii) MODERATE RESPONSE.
iii) MILD RESPONSE.
iv) POOR RESPONSE.
After 45 days of Treatment Period, the investigational product Vatsakadi
Qwatha showed good response in 10 subjects i.e 50%, Moderate response in 04
subjects i.e 20%, Mild response in 04 subjects i.e 20% and Poor response in 02
subjects i.e 10%.
After 90 days of Follow Up period, the investigational product Vatsakadi
Qwatha showed Good Response in only 02 subject’s i.e 10%, Moderate Response in
04 subjects i.e 20%, Mild Response in 08 subjects i.e 40% and Poor Response in 06
subjects i.e 30% Thus, the investigational product Vatsakadi Qwatha showed overall
significant result during treatment period than compared to Follow Up Period.
6. Discussion: This section deals with discussions pertaining to Nidana Panchaka,
Observations and Results obtained from the present study. The probable mode of
action of the investigational product Vatsakadi Qwatha based on Rasa Panchaka
theory of individual drugs in relation with the management of Madhumeha has been
discussed. This section also deals with the discussions regarding recent Pre-Clinical
- -
167
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
and Clinical Evidential Studies for each and every ingredients of the investigational
product Vatsakadi Qwatha along with its Phyto-Chemical Analysis.
7. Conclusion: This section deals with the conclusion of the above study by
highlighting the outcome of the study and the scope for further studies.
- -
168
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
BIBLIOGRAPHY 1. Acharya Agnivesha; Charaka Samhita; redacted by Charaka and Dridabala with
Ayurveda Dipika Commentary by Chakrapani Dutta; edited by Vaidya Yadavji
Trikamji Acharya; 4th Edition, 2001; published by Chaukhambha Surabharathi
Prakashana Varanasi, Uttar Pradesh.
2. Anonymous; Yogaratnakara, with Vidyotini Hindi Commentary by Vaidya
Lakshmipathi Shastri; 7th Edition, 1999; Chaukhambha Sanskrit Samsthan,
Varanasi, Uttar Pradesh.
3. Baghel M. S.; Researches in Ayurveda; Ed. Gajendra Kumar Jain; First Edition,
1997; Mridu Ayurvedic Publication and Sales, Jamnagar, Gujarat.
4. Acharya Bhavamishra; Bhavaprakasha, with Vidyothini Hindi Commentary by
Bhishagratna Sri Bramha Shankara Shastri and Sri Roopalal Vaishya; Eighth
Edition, 1997; Chaukhambha Sanskrit Bhavan, Varanasi, Uttar Pradesh.
5. Davidson, Sir Stanley; Davidson’s principles and practice of medicine, Ed C. R.
W. Edwards et al; 17th International Student edition 1995, reprinted 1998,
Churchill Livingstone, Edinburgh.
6. Harrison T. R. et al; Ed. Harrison’s principles of Internal Medicine; Vol. I & II,
17th International Edition, 1998; published by McGraw-Hill Book Co. Singapore.
7. Acharya Madhavakara; Madhava Nidanam, Uttarardha with Madhukosha
Vyakhya by Vijayarakshita and Srikanta Dutta, Vidyotini commentary by
Ayurvedacharya Sri Sudarshana Shastri; 29th Edition, 1999; Chaukhambha
Sanskrit Samsthan, Varanasi, Uttar Pradesh.
8. Acharya Sushruta; Sushruta Samhita with Nibandha Sangraha Commentary of Sri
Dalhana Acharya and Nyaya Chandrika Panjika of Sri Gayadasacharya; ed. by
Vaidya Yadavji Trikamji Acharya and Narayana Ram Acharya; Reprinted
Edition, 1998; Krishnadas Academy, Varanasi. Uttar Pradesh.
9. Vagbhatacharya; Ashtanga Hrudaya with commentaries Sarvangasundara of
Arunadutta and Ayurveda Rasayana of Hemadri, ed. by Pandith Bhishak Acharya,
Hari Shastri Paradkar Akola; 8th Edition, 2000; Chaukhambha Orientalia,
Varanasi, Uttar Pradesh.
10. Kumar, Kotran, Robins; Robbins Basic Pathology 7thedition 2003 Elsevier India
Pvt. Ltd, New Delhi.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
11. Sharangadhara; Sharangadhara Samhita with commentary Deepika of Adhamalla
and Gudharthadeepika of Kasirama vaidya edited by Parashuram Sastry.5th
edition:2002
Chaukhambha Orientalia, Varanasi, Uttar Pradesh.
12. K.V.Krishnadas; Textbook of Medicine, 3rd edition 1996 Jaypee Brothers,
Medical Publishers Pvt Ltd, New Delhi.
13. K.V.Krishnadas; Clinical Medicine, 3rd edition 2007 Jaypee Brothers, Medical
Publishers Pvt Ltd, New Delhi.
14. A group of physicians, API Textbook of Medicine®, 8th edition published by the
Association of Physicians of India and Distributed by The National Book Depot,
Mumbai.
15. Acharya Kashyapa – Kashyapa Samhitha, Text with English translation by
P.V.Tiwari, First edition, 1996. Chaukhambha Viswabharathi, Varanasi.
16. Acharya Vagbhata, Ashtanga Sangraham, Text with English translation by
Prof.K.R.Srikantha Murthy.5th edition 2005. Chaukhambha Orientalia, Varanasi,
Uttar Pradesh.
17. Acharya Chakrapani Dutta - Chakradutta, Edited and translated by P.V.Sharma,
2nd edition 1998. Chaukhambha Orientalia, Varanasi.
18. Acharya Haritha, Haritha Samhita, Edited with Asha Hindi Commentary by
Ramavalamba Shastry. First edition, Prachya Prakashan, and Varanasi.
19. Shayanabhashya - Rig-Veda, Edited by Raviprakash Arya, K.L.Joshi,
2ndEdition2001.Parimal Publications, Delhi.
20. J.L.N.Shastry, Dravyaguna Vijnanam, Second Edition 2005 Chaukhambha
Orientalia, Varanasi, Uttar Pradesh.
21. Atharvaveda, Translated to English by William D White Whitney, First
edition1987, Nag Publishers, Delhi.
22. DR. Virendra Keshav Shah; Diabetes Mellitus in Indian Medicine®, first
edition,1995 Chaukhambha Orientalia, Varanasi, Uttar Pradesh.
23. Dr V.Seshiah, A Hand book on Diabetes Mellitus®, 4th edition 2009, Dr. V.
Seshiah’s Diabetes Care And Research Institute, Chennai, All India Publishers &
Distributors, New Delhi & Chennai.
24. Dr P.G.Raman, Textbook of Diabetes Mellitus, 3rd edition, A.I.T.B.S Publishers®,
Krishnanagar, New Delhi.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
25. Dr Eric. J. Topol, Textbook of Cardiovascular Medicine®, Lippincott Williams
and Wilkins, 3rd Edition.
26. Dr James Dukes, Dukes Handbook Of Medicinal Herbs®, an e-book.
27. Dr R.C.Guyton, M.D†, Dr John.E.Hall, M.D†, Textbook of Medical Physiology,
11th edition, Elsevier Saunders.
28. Dr .Mark. N. Feingelos, M.D† and Dr M. Angelyn Bethel, M.D†, Contemporary
Endocrinology™, Type -2 Diabetes Mellitus, an Evidence Based Approach to
Practical Management, Humana Press.
29. Stephen J. McPhee, Maxine A. Papadakis, Eds, Ralph Gonzales, Roni Zeiger,
Online Eds. Current Medical Diagnosis and Treatment 2009, 48th edition, Tata
McGraw Hill.Inc.
30. Dr Bertram.G. Katzung, M.D†, PhD, Basic and Clinical Pharmacology, 10th
edition, Tata McGraw Hill press, P.O. Box 0450, University of California, San
Francisco, CA 94143-0450.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
REFERENCES
1. D.P. P. M. Pg: 808
2 Ka. Su 26/6-10
3 Ha. S. IIIrd sthana
4 Ka. Su.25/22
5 Sha.Sam7 /59-62
6. Bha. Pra.Ma.Kha.38
7 Y. R - U. Pg. 82
8. D.M.I. Pg.14
9. Shabdakalpadruma
10 Vachaspathyam
11 R.V- S.B (10/163/5)
12 A.H.Ni.10/18, Cha.Ni.4/44
13 Cha.Su.17/80
14 The Diabetes – Parashuram Shastry
15 Su.Chi.11/3
16 Cha.Chi.6/4
17 Su.Ni.6/3
18 A.H .Ni. 10/1-3
19 Cha.Ni.4/5
20 Cha.Ni.4/24
21 Cha.Ni.4/36
22 Cha.Su.17/78
23 Su.Ni.6/30
24 D.P. P.M.-Pg: 811,812
25 Cha. Ni 4/47
26 Su. Ni 6/5
27 A. H. Ni 10/38, 39
28 A.S .Ni 10/7
29 Ma.Ni 33/5
30 Su.Ni.6/25-26
31 Cha.Ni.4/44
32 A.P.I.T.M.-. Pg.1050
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
33 Cha. Ni 4/37
34 Cha.Chi.6/6
35 Cha.Chi.6/11
36 Cha.Su.17/78-80
37 Su .Ni. 6/30
38 Cha.Chi.6/8
39 A.H.Ni.10/4
40 Su.Chi.11/3
41 Su.Chi.11/3
42 Cha.Chi.6/57
43 Cha.Su.17/78-81
44 Cha. Chi 6/9-11
45 Su Ni 6/8
46 Ma.Ni 33 / 9-17
47 A.H.Ni10/8-18
48 Cha. Su 30/80
49 Cha. Ni 4/36
50 Cha. Chi 56/57
51 Cha. Chi 6/15, Su. Chi 11/3
52 R.P Pg.645
53 H.P.I.M-, Pg2110
54 Cha.Ni.4/48
55 Su.Ni.6/15
56 Su.Ni.6/15
57 Su.Ni.6/15
58 Cha. Chi 17/ 83
59 A.H Ni 10/25
60 Su. Ni 6/14
61 H.P.I.M-, Pg2116
62 D.P.P.M- -Pg.837.
63 D.P.P.M-Pg.837.
64 H.P.I.M-Pg.2125.
65 H.P.I.M-Pg. 2123.
66 H.P.I.M-Pg. 2125 & D.P.P.M-Pg.841
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
67 Cha. Chi 6/56
68 Cha.In.5/16
69 Cha.In.5/17
70 Cha.Chi.6/55
71 API T.M-Pg.1049-1050.
73 Cha. Chi.6/16,Su.Chi 12/6, A.H Chi 12/1
74 Cha. Chi. 6/25
75 Cha. Chi. 6/27-29
76 Su.Chi.11/9
77 Su.Chi.11/9
78 A.H.Chi-12/7
79 Cha.Chi-6/51
80 Cha.Chi-6/50
81 Su.Chi-12/6
82 Su.Chi-11/9
83 A.H.Chi-12/8
84 Cha.Chi-6/52
85 Su.Ni-6/30
86 Cha. Chi - 6/25
87 Su .Chi -14/10-11
88 H.P.I.M Pg2127
89 H.P.I.M Pg2133
90 Cha. Su- 28/45
91 B.R -37/244
92 B.R -37/270
93 D.P.P.M Pg.829
94 H.P.I.M – Pg 2128.
95 Cha. Su 1/125
96 Dravya Guna, Vol II- J. L. N. Shastry Pg.54.
97 The International Journal of Pharmacology-2008-volume6-number1 98 DRAVYA GUNA, Vol- II - J. L. N. Shastry Pg.220.
99 Textbook of Internal medicine, Tripathi et al.
100 Gopala Kumar et al ;1995
101 DRAVYA GUNA Vol II- J. L. N. Sastry Pg.203
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
102 Journal of Research in Ayurveda and Sidha v.21 (1-2):p.11-18,
2000 (Eng; 15ref). [Effect of Bala Haritaki on Hyper
Cholesterolaemia- Sood.R; Sharma A. K (P.G Dept. of KC, Jaipur]
103 DRAVYA GUNA Vol II- J. L. N. Shastry Pg. 216
104 Yadavji Trikamji Acharya, Dravya guna, vol-3.
105 BMC Complimentary and Alternative Medicine 2006
106 DRAVYA GUNA Vol II- J.L.N. Shastry Pg. 314
107 Pillai et al (DRAVYA GUNA Vol II- J.L.N. Shastry page 315 )
108 DRAVYA GUNA Vol II- J. L. N. Shastry, Pg.152
109 Biological and Pharmaceutical Bulletin-The pharmaceutical
Corporation of Japan 2004 - JA, www.3pdf.com.
110 Chakradutta.D.Prameha Chikitsa-35/19.
111 Sha. Sam.P.K-4/45
112 Cha. Ni 4/6
113 Cha. Vi 5/8
114 The Lancet, Volume 360,Issue 9344,page 1477-
478(R.VanDam, E.Feskens) Elsivier.com
115 Journal- Diabetologia [( Issue-Vol- 49, page 1770-1776 )] dated
08/Aug2006)]
116 Fitoterapia, issue1, January 2004 pages 1-4, Anti-diabetic potential of
Pterocarpus marsupium extracts in rats.
117 Effects of red wine, tannic acid, or ethanol on glucose tolerance in non
Insulin Dependent Diabetic Patients and on starch digestibility in vitro
Universite de Ordeaux II, Bordeaux Cedex, France) Journal of
Ethnopharmacology, vol108, issue2, Nov 2006 page 280-286.
118 Indian Journal of pharmacology, 2010, Source – www.ijp-online.com.
119 Net source - http://www.bionewsonline.com/i/2/antimicrobial_b.html.
120 Textbook of Medical Physiology, Guyton 11th edition chapter 78.
121 Textbook of Cardiovascular Medicine Eric j Topol 3rd edition.
122 Type 2 Diabetes Mellitus by mark n Feinglos and M Angelen Bethel.
123 Handbook of diabetes mellitus by Dr V. Seshiah, Chennai.
124 Dukes handbook of medicinal herbs
125 Ayurvedic Pharmacopoeia of India.
126 Current Medical Diagnosis and Treatment- 2009.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
CASE REPORT FORM
POST GRADUATE DEPARTMENT OF KAYACHIKITSA
A.L.N. RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE, KOPPA
P.G. Scholar: Dr.Srikrishna H.A Guide: Dr .Suresh. R.D,
MD (Ayu), MS(C&P),CYS..
Patient’s Name: SL No:
Age/ Sex: ….Yrs M/F OPD/IPD:
Religion: Ward/Bed No:
Education: D.O.A:
Marital Status: D.O.D:
Occupation: Diagnosis:
Postal Address: Result:
PATIENT CONSENT FORM
I __________________________________________ exercising my
free power of choice, hereby give you my complete consent to be
included as a subject in the present Clinical Study. I have been
informed to my satisfaction by the attending Doctor, the purpose of the
Clinical Study and the nature of drug treatment, therapeutic procedures,
follow-up and probable complications. I am also ready to undergo
necessary Laboratory Investigations to monitor and safeguard my body
functions.
I am also aware of my right to opt out of the trial at any time
during the course of the trial without having to give the reasons for
doing so.
Signature of the Doctor Signature of the Patient/ Guardian
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
CHIEF COMPLAINTS
1) Prabhutamutrata with Duration:
Amount of urine: Markedly increased / Increased / slightly increased/Normal
Frequency of urination:
Diurnal: Markedly increased / Increased/ Slightly increased/ Normal Nocturnal: Markedly increased/ Increased/ Slightly increased/ Normal
2) Avilamootrata (Turbid Urine) with Duration:
Appearance of Urine: Grading with Standard Sample (Testube Background
News paper method)
Clearly readable/Readable/can read with difficulty/cannot read the letters.
3) Pipasa with Duration:
Markedly increased / Increased / slightly increased/Normal
4) Kshudha with Duration:
Markedly increased / Increased/ slightly increased/ Normal
5) Sweda Pravruthi with Duration:
Markedly increased / Increased/ slightly increased/ Normal
6) Karapadathala Daha with Duration:
Markedly increased / Increased / slightly increased/Normal
7) Karapadathala Suptata with Duration:
Markedly increased / Increased / slightly increased/Normal
8) Dourbalyam with Duration:
Markedly increased / Increased / slightly increased/Normal
HISTORY OF PRESENT ILLNESS
HISTORY OF PAST ILLNESS
FAMILY HISTORY
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
1. Known DM in first degree relative - Present/Absent 2. Known DM in second degree relative - Present/Absent 3. Known DM in third degree relative - Present/Absent
PERSONAL HISTORY
Habits: Micturition:
Diet: Bowel habit:
Vyayama: Appetite:
Nidra: Others:
MENSTRUAL HISTORY
GENERAL EXAMINATION
Pulse: Built:
B.P: Pallor:
Temperature: Icterus:
Heart Rate: Cyanosis:
Respiratory rate: Edema:
Lymphadenopathy: Nail changes:
Height: Weight:
Physique: Obese / Moderately Built/ Asthenic
SYSTEMIC EXAMINATION
1. Urinary System: Inspection: Skin: Dry and flaky / dirty brown appearance / Uremic frost on the forehead / Pitting oedema on ankles and sacrum/oedema at genitals/facial puffiness. Nail: Leuconychia/Splinter Hemorrhages Palpation: Left kidney: Palpable lower end (abnormal) /not palpable (normal) Right kidney: Lower end Palpable (normal) / not palpable (if removed) If abnormal: Unilaterally palpable kidney / bilaterally palpable kidney 2. Cardiovascular System:
Inspection and palpation:
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
Arterial pulse: Tachycardia/Bradycardia/normal
Rhythm: Normal/abnormal
Abnormal pulsations on Precordium: present/absent
Blood Pressure:
Auscultation:
Abnormal Heart Sounds: Murmurs/ Additional heart sounds
The peripheral pulses of upper limb: All present and equal/ All present and unequal/Absence of pulses noted.
The peripheral pulses of lower limb: All present and equal/ all present and unequal/Absence of pulses noted.
Bruits: Present/Absent
Abnormalities on ECG:
Central Nervous System:
Mental stage:
Gait:
Cranial Nerves:
Fundi:
Pappiloedema: Present/Absent
Optic atrophy: Normal/Abnormal
Hypertensive changes/Ureamic changes/Diabetic changes
Motor:
Sensory:
Position sense in fingers and toes (Post. Columns): Normal/ Abnormal
Pin prick test of limbs and face (Lateral Spinothalamic tract): Normal/Abnormal
Response to light touch - positive/negative.
ASTASTANA PAREEKSHA:
1. Nadi: 5. Sabda:
2. Muthram: 6. Sparsa:
3. Malam: 7. Drik:
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
4. Jihwa: 8. Akruti:
DASAVIDHA PAREEKSHA
Prakruthi:
Sara:
Samhanana:
Pramana:
Satva:
Satmya:
Vyayamasakthi:
Aharasakthi:
Vaya:
Vikruthi:
SROTHO PAREEKSHA
1. Udakavahasrothas: Jihva Shosha/ Talu Shosha/Oshta Shosha/Kanta Shosha/Mukha Shosha/Tamas/ Pravrudhapipasa
2. Rasavahasrotas: Shithilagatrata/ Karapadasupthatha/ Klaibya/ Shrama/Agnimandya/Gourava/Alasya/Atinidra/Asyamadhurya/Arasajnata/Aruchi
3. Rakthavahasrotas: Karapadasupthatha/ Karapadadaha/ Rakthasrava/ Pidaka/ Vidradhi/ Kotha/ Mukhapaaka
4. Muthravahasrothas: Prabhuthamutrata/ Avilamutrata/ Makshikaakranta Mutrata (Pipilika Abhisarana)/ Sashulamutrata NIDANAM
1. AHARAM Present Absent
a) Excess carbohydrate rich Diet
(Rice, Jaggery and Grains etc..)
b) Excess fat rich Diet
(Curd, Anupa mamsa, Oudaka Mamsa, Butter, Sweets, Mamsa of Domestic animals)
c) Amount of food Mild Moderate Excess
2. VIHARAM Present Absent
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
a) Asyasukham
(Sedentary sitting & Sex habits)
b) Swapnasukham
(Sedentary sleeping Habits)
c) Lack of exercise
3. MANASIKA NIDANA Present Absent
a) Chintha
b) Shoka
c) Udwega
PURVARUPAM
Present Absent
a) Karapadathaladaham
b) Pipasa
c) Dantamalam
d) Nayanamalam
e) Karnamalam
f) Alasyam
g) Shareera Dourgandhyam
h) Athinidra
i) Athithandra
j) Karapadathalasuptatha
k) Keseshu Jatileebhavam
l) Asyamadhuryam
DHATU INVOLVED SYMPTOMS
a) Rasa (Vruddhi): Praseka/ Alasya/ Gaurava
b) Medas (Vrudhi): Shramaswasa,/ Lambhana of Sphik/Stana
c) Majja (Ksheena): Asthisousheerya - Present/ Absent
d) Vasa (Ksheena): Mamsakshaya - Present/ Absent
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
e) Lasika: Mamsatwagantara Udaka Kshaya - Present/Absent
f) Ojus (Ksheena): Impaired Psychological, physical or Disease
Specific strength of the individual - Present/ Absent
UPASAYAM / ANUPASAYAM
SAMPRAPTI GHATAKA
Dosha : Dushya :
Srotas : Srotodushti :
Agni : Ama :
Udbhava sthana : Sanchara Sthana:
Adhishtana : Vyaktha sthana:
Rogamarga : Vyadhi swarupa :
INVESTIGATIONS
No
BIOCHEMICAL INVESTIGATIONS RESULTS
1 F.B.S
2 P.P.B.S
3 HbA1C
4 F.U.S
5. P.P.U.S
DIAGNOSIS: Madhumeha
Treatment Started on:
Treatment Ended on:
Follow up Started on:
Follow up Ended on:
Medicine: Vatsakadi Qwatha
Treatment Duration: 45 days
Follow up Duration: 90 days.
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
ASSESMENT OF RESULTS
Parameters B.T D.T AT AFU No
Subjective 0 15 30 45 60 75 90 105 120 135
1.a P.M(Amount)
B P.M (Frequency)
2 Avilamutrata
3 Pipasa
4 Kshudha
5 Sweda Pravruthi
6 Karapadathala Daha
7 Karapadathala Suptata
8 Dourbalyam
Objective 0 15 30 45 60 75 90 105 120 135
Blood Sugar
FBS
1
PPBS
HbA1C
Urine Sugar
FUS
2
PPUS
REMARKS: No response Mild response
Moderate response Marked response
Signature of P.G Scholar Signature of Guide
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
DQOL Questionnaire
Sl no. QUESTIONS SCORING I. PHYSICAL 1. How often do you feel physically ill? 1 2 3 4 5
2. How often do you have bad night sleeps? 1 2 3 4 5
3. To what extent do you have difficulty in performing your routine activities?
1 2 3 4 5
4. How much are you bothered by any limitations in performing everyday living activities?
1 2 3 4 5
5. How often do you feel fatigue? 1 2 3 4 5
II. PSYCHOSOCIAL 1. How satisfied are you with your social relationship? 1 2 3 4 5
2. How often do you feel good about yourself? 1 2 3 4 5
3. Do you get the kind of support from others that you need?
1 2 3 4 5
4. How much do you experience positive feelings in your life?
1 2 3 4 5
5. How well are you able to concentrate? 1 2 3 4 5
III. SEXUAL 1. How often does your diabetes interfere with your sex
life? 1 2 3 4 5
2. How satisfied are you with your sex life? 1 2 3 4 5
3. How often are you worried about your sexual life? 1 2 3 4 5
4. Are you bothered by any difficulties in your sex life? 1 2 3 4 5
5. How well are your sexual needs fulfilled? 1 2 3 4 5
IV. SATISFACTION IN LIFE 1. How satisfied are you with the quality of your life? 1 2 3 4 5
2. How much do difficulties with transport restrict your life?
1 2 3 4 5
3. To what extent are you hopeful about your life? 1 2 3 4 5
Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)
4. To what extent do you feel peaceful within yourself? 1 2 3 4 5
5. To what extent does faith contribute to your well-being? 1 2 3 4 5
V. TREATMENT SATISFACTION 1. How willing are you to take medications? 1 2 3 4 5
2. How much do you need any medication to function in your daily life?
1 2 3 4 5
3. How dependent are you on medications? 1 2 3 4 5
4. How satisfied are you about the present treatment? 1 2 3 4 5
5. How confident are you with the outcome of the treatment?
1 2 3 4 5
HEALTH PERCEPTION*
1. Compared to others of your age would you say your health is
E G F P VP