by dr. dinesh gupta dissertation submitted to the rajiv

166
PHARMACEUTICO ANALYTICAL AND CLINICAL STUDY OF ROMASHATANA LEPA W.S.R. TO ITS DEPILATION ACTIVITY.” BY DR. DINESH GUPTA Dissertation Submitted to the Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore. In partial fulfillment of the requirements for the degree of AYURVEDA VACHASPATHI (DOCTOR OF MEDICINE) In RASASHASTRA Under the Guidance of Dr. JAGADEESH G. MITTI, M.D. (Ayu), Ph.D Asst Professor Dept. of Rasashastra DEPARTMENT OF RASASHASTRA, POST GRADUATE STUDIES AND RESEARCH CENTER, SHRI D. G. MELMALAGI AYURVEDIC MEDICAL COLLEGE, GADAG 582103. 20010-2013

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“PHARMACEUTICO ANALYTICAL AND CLINICAL STUDY OF

ROMASHATANA LEPA W.S.R. TO ITS DEPILATION ACTIVITY.”

BY DR. DINESH GUPTA

Dissertation Submitted to the Rajiv Gandhi University of Health Sciences,

Karnataka, Bangalore.

In partial fulfillment of the requirements for the degree of

AYURVEDA VACHASPATHI (DOCTOR OF MEDICINE)

In

RASASHASTRA

Under the Guidance of

Dr. JAGADEESH G. MITTI, M.D. (Ayu), Ph.D

Asst Professor Dept. of Rasashastra

DEPARTMENT OF RASASHASTRA,

POST GRADUATE STUDIES AND RESEARCH CENTER,

SHRI D. G. MELMALAGI AYURVEDIC MEDICAL COLLEGE,

GADAG – 582103.

20010-2013

SHRI D. G. MELMALGI AYURVEDIC MEDICAL COLLEGE,

POST GRADUATE STUDIES AND RESEARCH CENTER

GADAG - 582 103

This is to certify that the dissertation entitled “PHARMACEUTICO ANALYTICAL

AND CLINICAL STUDY OF ROMASHATANA LEPA W.S.R. TO ITS

DEPILATION ACTIVITY.” is a bonafide research work done by DR. DINESH GUPTA

in partial fulfillment of the requirement for the degree of Ayurveda Vachaspathi / M.D

(Rasashastra).

Date:

Place: Gadag Guide :

Dr. Jagadeesh G. Mitti, M.D. (Ayu), Ph.D.

Asst. Prof, Department of Rasashastra,

Post Graduate studies and research center

D.G.M.A.M.C, Gadag.

J.S.V.V. SAMSTHE’S

D.G.M. AYURVEDIC MEDICAL COLLEGE

POST GRADUATE STUDIES AND RESEARCH CENTER

GADAG, 582 103

ENDORSEMENT BY THE H.O.D , PRINCIPAL OF THE

INSTITUTION

This is to certify that the dissertation entitled “PHARMACEUTICO ANALYTICAL

AND CLINICAL STUDY OF ROMASHATANA LEPA W.S.R. TO ITS

DEPILATION ACTIVITY.”

is a bonafide research work done by Dr. Dinesh Gupta under the Guidance of Dr.

Jagadeesh G. Mitti, M.D(Ayu), Ph.D. Asst. Prof, Post Graduate Department of

Rasashastra.

Dr. M. C. Patil, M. D. (Ayu.) Dr. G. B. Patil.

Professor and H. O. D. Principal,

Post graduate Dept. of Rasashastra. D.G.M.A.M.C, Gadag.

D.G.M.A.M.C, Gadag.

Date: Date:

Place: Gadag Place: Gadag

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore.

DECLARATION BY THE CANDIDATE

I hereby declare that this dissertation / thesis entitled “PHARMACEUTICO

ANALYTICAL AND CLINICAL STUDY OF ROMASHATANA LEPA W.S.R. TO

ITS DEPILATION ACTIVITY.”

is a bonafide and genuine research work carried out by me under the Guidance of

Dr. Jagadeesh G. Mitti, M.D. (Ayu), Ph.D. Asst. Prof, Post Graduate Department of

Rasashastra, DGMAMC, PGS & RC, Gadag.

Date:

Place: Gadag Dr. Dinesh Gupta

COPYRIGHT

Declaration by the candidate

I hereby declare that the Rajiv Gandhi University of Health Sciences, Karnataka

shall have the rights to preserve, use and disseminate this dissertation / thesis in print or

electronic format for academic / research purpose.

Date:

Place: Gadag Dr. Dinesh Gupta

© Rajiv Gandhi University of health Sciences, Karnataka

Acknowledgement

At this amenity of successful integrating of my work, I bow my head on the feet of

MATA SATYOVATI.

There is hardly any task which is more pleasant than acknowledgement my gratitude

to all those who have helped in so many ways in preparing this work.

I have no words to express my gratitude towards my affectionate grandfather Late

Sh. Som Raj Gupta and parents Smt. Shreshtha Gupta, Sh. Ramesh Kumar, whose blessings

made me to progress and whose love and guidance helped me to overcome all the obstacles

in my life.

It is my proud and privilege to express my extreme sense of indebtedness to my

guide Dr.Jagadeesh G.Mitti M.D(Ayu) PhD, Asst.Prof, PG Dept of Rasa shastra, for his

invaluable and ever available help and guidance.

I pay my reverences to my HOD and Prof Dr.M.C.Patil, M.D(Ayu) who has

blessed me with his valuable guidance and profound knowledge. His suggestion will always

be helpful for me in every step of my life.

I express my gratitude with due respect to our Principal Dr.G.B.Patil.

I extend my gratefulness to Dr.Suvarna B.Nidagundi and Dr. M.B. Sobagin whose

valuable suggestions helped me to complete my work.

I acknowledge my sincere thanks to Dr.Ashok Patil, M.D(Ayu) for his valuable

guidance and help from the beginning of my P.G.studies to till date.

I acknowledge my sincere thanks to my brothers & sisters in law Sh. Rajeev Gupta,

Smt Anu Gupta & Dr. Hitesh Gupta, Dr Preety Gupta for their kind co-operation and help

during study and throughout life.

I pay my heartful thanks to my dear niece and nephew Dhaanya and Daksh whose

joyful face and naughtiness kept me relaxed.

My special thank to my friend as well as my roommate Dr Tribhuvan Singh

Pareek for his kind co-operation in completing the work.

I extend my gratitude to Shri V.M.Mundimani, Mr.Shavi, and Mr.Karur for providing

the required books during the study.

I cannot forget the love and timely co-operation offered by my friend, Dr Pruthvi, Dr

Narinder Vats, Dr Paramjeet Puri, Dr Utkarsh Singh Nehra, Dr Neil Rasal, Dr Shiv Kumar

B.N, Dr Mohit Arora, Dr Jithin. K, Dr Varun Sharma, , Dr Vijay, Dr Niranjan, , Dr Girish

Tollamiti, Dr Gouri Priya, Dr Bhavya, Dr Amita Sharma, Dr Manjunath, whose support is

always comforting to me.

My sincere thanks to my Senior Friends Dr.R.C.Satish, Dr. Vinod Barwal, Dr B.Dass,

Dr.Vijay Raj, Dr Gigi Mathew, Dr Annidev, and Dr Geeta, Dr Manish Ladave, and during

this work and beyond this work. Their love and affection can not be bounded under the

single word “Thanks” I will be always in need of their love and affection.

I express my special thanks to my junior friends Dr Ashish, Dr Muneesh, Dr Shweta,

Dr Ambilli, Dr Muskan, Dr Prakesh Meti, Dr Shail, Dr Sanjay, Dr Raj, Dr Vimal, Dr Vikas,

Dr Kushal and Dr Uday for their kind co-operation in completing the work.

With pleasure I extend my sincere gratitude to non teaching staff Smt.Patil,

Smt.Shamshad, Smt.Mangala, Manjunath, Shettappa Gouda and Prabhu for their co-operation

and help during the study.

Last but not least I thankful to all those persons who directly or indirectly helped me

in this work.

DR DINESH GUPTA.

ABBREVIATIONS

1. A.P Ayurveda Prakasha

2. A.K Ananda Kanda

3. Ay.R.S Ayurvediya Rasa Shastra

4. B.P. Bhava Prakasha

5. Br.R.R.S Brihat Rasa Raja Sundar

6. Br.Y.T Brihat Yoga Tarangini

7. B.R Bhaishaja Ratnavali

8. R.K. Rasakamadenu

9. R.Ni Raja Nighantu

10. R.T. Rasa Tarangini

11. R.Cu Rasendra Chudamani

12. R.S.S Rasendra Sara Sangra

13. R.H.T. Rasa Hridaya Tantra

14. R.Mr. Rasamrutha.

15. R.P.S. Rasa Prakasha Sudhakar

16. R.R.S. Rasa Ratna Samuchaya

17. Ra.Ci.Vi Rasa Chikitsa Vignana

18. S.P.S Siddha Prayoga Sangraha

19. Sh. Sm. Sharangdhara samhita

20. Y.R. Yoga Ratnakar

ABSTRACT

Background:

Unwanted hairs which are present in the body causes cosmetological as well as

psychological problems for an individual .To remove the unwanted hairs there are numerous

medicines and procedures, which are carried out for depilation action.

These medicines are mainly chemicals have side effects and irritation to the skin. The

techniques which are employed for this purpose are expensive; still the relapse of the hair

occurs because these are giving temporary results.

In present study an attempt was made to evaluate the efficacy Romashatana Lepa in Foot

Hairs.

It comprises.

1.Introduction:

It introduces the subjects by laying emphasis on its importance in present time.

As there are so many medicines which are available in the market for the other

diseases like jwara, sandhgataivata, amavata, amalpitta, shwasa, kasa etc. but for the

romashatana there are no such frequently available medicine.

The hair removal products which are available in the market are not herbal or

herbomineral. They are chemicals and have their side effects also. Plan of study is also

dealt.

2.Review of Literature:

It is based on Ayurvedic texts and also modern pharmacotherapeutic properties of Haratala,

Shanka, Palasha kshara & updated with recent medical journals, internet etc.

3.Methodology:

a) Pharmaceutical study: This Chapter includes the relation of raw materials, churnikarana

of shankh, shodhana of hartala, preparation of palasha kshara, churnodaka nirmana.

b) Analytical study: This Chapter includes the organoleptic & chemical analysis of

romashantana lepa.

c) Clinical study: This includes the clinical study of romashatana lepa w.s.r. to its

depilation activity. 30 volunteers were taken from the OPD of the D.G.M Ayurvedic

Medical College. Out of which 13 volunteers were male and 17 volunteers were female

Results:

In this part the results obtained are systematically presented, which include data

related to response to treatment. The lepa shows complete result in 28 volunteers (i.e.

93.33%) out of 30 for growth of in hair in 3 sq. cm area and 2 volunteers (i.e. 6.67%)

shows marked result. 17 volunteers (i.e. 56.66%) had shown complete result for number of

hair in 3 sq. cm area and 13 volunteers (i.e. 43.33%) had shown marked result.

Discussion:

In this chapter observation, findings and results of studies have been found out with

possible explanation for its effects.

Conclusion:

The essence of the whole study is mentioned in this chapter.

Summary:

It contains the information of the overall work in a nut shell.

Keywords:

Romashatana lepa, hartala, palasha kshara, shankha, analytical study, clinical study ,

depilatory effect.

CONTENTS

S. No Index Page No

1 Introduction 1-3

2 Objectives 4

3 Review of literature 5- 62

Concept of kasha, roma, loma 5-14

Reasons for hair fall 15-20

Methods of hair removal 21-25

Bahaya kalpana 26-30

Drug review 31-62

4 Methodology 63-83

Pharmaceutical study 63-73

Analytical study 74-78

Clinical study 79-83

5 Observation and Results 84-103

6 Discussion 106-115

7 Conclusion 116-117

8 Summary 118-119

9 Bibliography 120-138

LIST OF TABLES

S.

No

Tables Page No

01 Variations with vatala prakruti. 5

02 Varitions with pittaja prakruti 6

03 Varitions with kaphaja prakruti 6

04 Quantity sneha dravya in lepa formulation according to

doshas.

28

05 Thickness of the lepas while application 29

06 Synonyms of hartala 30

07 Types of haratala 32

08 The difference of main two types: Patra and Pinda 32

09 Ashodhita haratala sevana doshas 34

10 Pharmacological properties of hartala 35

11 Shodhana Of Haratala 36

12 Shuddha Talaka Guna 37

13 Marana of hartala 38

14 Talaka Sattvapatana Of Hartala 39

15 Synonyms of Shankha 47

16 Rogaghnata of Shankha 49

17 Pharmacological properties of Palasha 54

18 Desirable qualities of kshara 57

19. Undesirable qualities of kshara 57

20. Pharmacological properties of arka 60

21. Results of process of : Shankha churnikarna 67

22. Results of process of : Hartala shodhana 69

23. Results of process of palasha kshara 71

24. Results of preparation of romashatna lepa 73

25. Showing the analytical report 78

26. Gradation which is adopted in statistical evaluation 82

27. Gradation which is adopted in statistical evaluation 82

28. Distribution of volunteers by age groups 84

29. Distribution of volunteers by Sex 85

30. Response before and after the treatment.(for no.of hair) 86

31. Response before the treatment and on follow up .(for no.of

hair)

87

32. Response before and after the treatment in males .(for no.of

hair)

88

33. Response before the treatment and on follow up in males

.(for no.of hair)

89

34. Response before and after the treatment in females .(for

no.of hair)

90

35. Response before and after the treatment in females. .(for

no.of hair)

91

36. Response before and after the treatment (for growth of hair ) 92

37. Response before the treatment and on follow up. (for growth

of hair )

93

38. Response before and after the treatment in males (for

growth of hair )

94

39. Response before the treatment and on follow up in males (for

growth of hair )

95

40. Response before and after the treatment in females (for

growth of hair )

96

41. Response before the treatment and on follow up in females

(for growth of hair )

97

42. Overall result for number of Hair in 3 sq. cm area 98

43. Overall result of Growth of Hair in 3 sq. cm area 99

44. Overall result for number of Hair in 3 sq. cm area in males 99

45. Overall result for number of Hair in 3 sq. cm area in females 100

46. Overall result for growth of Hair in 3 sq. cm area in males 101

47. Overall result for growth of Hair in 3 sq. cm area in females 101

48. Statistical analysis before treatment and after treatment .\ 102

49 Statistical analysis before treatment and on follow up. 103

LIST OF GRAPH

Graph

No Contents Page No

01. Showing Distribution of volunteers by age Group 84

02 Showing the distribution of volunteers by Sex. 85

03 Showing response before and after the treatment.(for no.of hair) 86

04 Showing response before the treatment and on follow up .(for no.of

hair) 87

05 Showing response before and after the treatment in males .(for no.of

hair) 88

06 Showing response before the treatment and on follow up in males

.(for no.of hair) 89

07 Showing response before and after the treatment in females .(for

no.of hair) 90

08 Showing response before and after the treatment in females. .(for

no.of hair) 91

09 Showing response before and after the treatment (for growth of hair ) 92

10 Showing response before the treatment and on follow up. (for growth

of hair ) 93

11 Showing response before and after the treatment in males (for growth

of hair ) 94

12 Showing response before the treatment and on follow up in males

(for growth of hair ) 95

13 Showing response before and after the treatment in females (for

growth of hair )

96

14 Showing response before the treatment and on follow up in females

(for growth of hair )

97

15 Showing overall result for number of hair in 3 sq. cm area. 98

16 Showing overall result for growth of hair in 3 sq. cm 99

LIST OF PHOTOGRAPHS:

S.no Photographs

1 Raw Drugs

2 Pharmaceutical procedures

3 Clinical study

LIST OF FIGURES:

S.No Figure Page no

1 Longitudinal section of hair in follicle 7

2 Layer of hair follicle 8

17 Showing overall result for number of hair in 3 sq. cm area in males

100

18 Showing overall result for number of hair in 3 sq. cm area in females 100

19 Showing overall result for growth of hair in 3 sq. cm in males 101

20 Showing overall result for growth of hair in 3 sq. cm in females. 102

Introduction

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity Page 1

INTRODUCTION

Rasashastra is a branch of medicine, which deals with metals and minerals to

produce the drugs with higher efficacy in lower doses and with good palatability. Thus it

became the branch, which fulfill the aims and objectives for, preparation of “Shreshtha

Bhaishajya” i.e “Best medicine”.

My present study is on depilation activity of Romashatana Lepa, this is a

herbomineral preparation from Sharangadhara Samhita, who says that after applying the

romashatana lepa , that part becomes soft like the head of the bouddha bhikshu & in that

part regrowth will be totally nil.1

Our Acharyas were so keen observers and practical people, they highlighted even

minute aspects of science. All the things they presented were well established facts. But, in

the modern world for the implementation of our science we need to prove it in terms of

modern science and technology because Science remains as philosophy when not

implemented and any true Ayurvedist doesn’t want to be only philosophical.

So the present study on depilation activity of Romashatna lepa is sincere effort in

this regard.

Sharangadhara has not mentioned that where this lepa can be applied like it should

be tested on the loma, kesha, smashru?

According to modern anatomy & physiology there are only two types of hair one is

vellus and other is terminal.

Introduction

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity Page 2

Modern anatomy till date is unable to mark any difference in the anatomy &

physiology of these two types of hair.

According to the embryology 4 classes of pilosibacious units have been identified in

fetal life. Modern Science has just been identified the pilosibacious units, but has not

discovered any difference in their anatomy and physiology but there is difference in , rate

of growth in these different hair, seasonal variations, hormonal effects and poisonous effect

which indicates some difference between anatomy & physiology of these different body

hair.

Our ancient scholars also had in – depth knowledge of these differences, so only

they have mentioned different names viz, kesha, loma, & smashru which coincide with the 4

classes of the pilosibacious units of embryonic life. They also have mentioned when the hair

follicles start appearing in the fetal life & when they are completely formed, which is

exactly similar to advanced modern science which has come to know about these facts only

with the help of ultra modern gadgets.

For lepa kalpana, a uniform particle size of powder , a uniform thickness of paste

and same time and region has to be selected. So, only one has to think on the other hair

removal techniques and medicines and has to compare their efficacy as well as cost with our

classical romashatna lepa.

One has to think on as why all the classical romashatana yogas are kshariya dravyas,

or even contain some kshara.

Introduction

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity Page 3

One has to look upon the modern medicines which cause hair fall as side effects &

what is the pharmaco kinetics? Even some poisons & cytotoxic drugs are known to cause

hiar fall. By knowing the aetiopathology, can we arrive to possible hypothesis, as how they

can cause permanent romashatana.

Within India also there is regional variation in hair. In Kerala people have long and

thick hair, where as the people of Rajasthan and Tibet do not have such long and thick hair

.In long hair the mitotic activity of germ cells is more, so the growth is more.

As there are so many medicines which are available in the market for the other

diseases like jwara, sandhgataivata, amavata, amalpitta, shwasa, kasa etc. but for the

romashatana there are no such frequently available medicine.

The hair removal products which are available in the market are not herbal or

herbomineral. They are chemicals and have their side effects also.

During the depilation study one has to keep in mind all the above points. In my

study I have tried my level best to discuss elaborately all the points.

Previous work done

Pharmaco analytical study of harataladi yoga and its effect on permanent lomashatana . By

Dr Miliind Hukkari in 1999. From K.L.E. Belgaum., Karnatka, under Rajiv Gandhi

University of Health Sciences, Karnataka Banglore.

Objective

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 4

OBJECTIVES OF THE PRESENT STUDY

The present study was planned with the following aims and objectives.

1. Preparation of Romashatana Lepa.

2. Physico chemical analysis of Romashatana Lepa.

3. Clinical assessment of depilating effect of Romashatana Lepa.

Review of Literature

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 5

CONCEPT OF KESHA , ROMA, LOMA

In Ayurvedic classics, there are a lot of references about kesha.

Garbhotpatti takes place by the samyoga of the shukra shonita and jeevatmain kukshi. Rutu,

kshetra, ambu, beeja are the grabhotpadak bhavas. There are 6 garbha nirmikar bhavas2,3,4

Matraj Pitraj Atmaj

Satmyaj Rasaj Satvaj

Out of these all sthira and kathina bhava are pitraja bhava viz kesha, smashru, loma, nakha,

asthi, danta, sira, snayu, dhaminies, retus.5

Loma are formed during the 4th

month of fetal life according to Harita. According to the

Vridha Vagbhata kesha, roma, asthi, nakha, abhivyakti takes place in the 6th

month.6

Kesha frow from twak only.

Prakruti and variations of kesha

Table no.01- showing variations with vatala prakruti.

Vagbhata 7

Kesha sparse and grey coloured.

Sushruta 8

Sparse, dry hair, moushtaches.

Sharangdhara 9

Kesha sparse

Review of Literature

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 6

Table no.02- showing varitions with pittaja prakruti.

Vagbhata 10

Kesha less romayukta

Sushruta 11

Viral kesha

Sharangdhara12

Premature greying of hair

Table no.03 showing varitionns with kaphaja prakruti.

Vagbhata 13

Thick and dry coloured hair

Sushruta 14

Thick , dark colour and curly hair

Sharangdhara15

Thick and snigdh hair

Kesha And Dhatu And Mala Sambhanda:

Dhatu - asthi16,17

In medasara purasha kesha are snigdha.18,19

Anatomy of Hair20,21

The hair can be divided into two parts, the root and shaft. The root part of hair is in the skin

(epidermis) of scalp. A pouch like structure called follicle surrounds the hair root. The base

of hair root is in the shape of abulb. Capillaries and nerve fibers indent this bulb. The cells

in the center of bulb divide. The newly divided hair cells push the previous cells up. The

cells, which move upwards, die slowly forming hard hair shaft.

Review of Literature

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 7

Hair is composed primarily of proteins (88%). Theseproteins are of a hard fibrous type

known as keratin. The hair shaft has three layers the cuticle, medulla and cortex.

Cuticle is the outer layers and protects the innerlayers. It is transparent. Healthy cuticle

gives a shinyappearance for hair and unhealthy cuticle giveslifeless look

Medulla is the innermost layer composed of largecells.

Cortex is the layer between cuticle and medulla. Thiscontains pigment and keratin. Cortex

determines thebulk and strength of hair.

Review of Literature

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 8

Fig2- showing layer of hair follicle

The hair follicle contains oil-secreting glands, which make the hair shiny. Stress and illness

and lack of proper nutrients diminish secretion of oil and pigments causing graying of hair.

The hair is considered as a tissue which uses the same nutrients of bone, nails and which is

formed as bi-product of bone tissue.

Composition of hair keratin

Keratins are a group of insoluble cystine proteins produced in the epidermal tissues of

vertebrates. Hair contain hard keratin, which differ from the soft keratin of desquamting

tissues by its higher sulphur content.

Problem

Chemical analysis of keratin is complicated, because the earlier procedures to render it

soluble by breaking the disulphide links of an interchain, intramolecular or intermolecular

can also cleave peptides.

Review of Literature

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 9

Hair differentiation

There are 4 classes of pilosebacous units, terminal hair on the scalp & beard ,

apopilosebacous in axilla and groin, vellus on the majority of skin, and sebaceous on the

chest, back and face.

Cyclic activity of the hair follicle

The duration of the follicles or anagen , varies greatly between species, in any species from

region to region and with age.

In human vellus follicles of both sexes, the period of activity is ranged from about 40- 80

days . For terminal hair in young japneese males, the length of the anagen has been

estimated at 19-26 weeks on leg, 6-12 weeks on arm, 4- 13 weeks on finger, 4-14 weeks in

moustache & 8-24 weeks in the region under the temple.

In stage 1 of anagen , cells at the base of epithelial sac- the secondary germ- begin to show

the mitotic activity.

In stage 2 , the lower part of the follicles goes down, partly enclosing the dermal papilla.

The inner root sheath appears as keratinized plate like structure overlying the matrix. At the

same time, cells in the dermal papillae enlarge and begin to become separated by an extra

cellular matrix.

In anagen 3 the keratinizing inner root sheath assumes a conical shape and the cortex starts

to differentiate beneath it. Tyrosine activity and melanogeno genisis become apparent in

melanocytes in the matrix. I

Review of Literature

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 10

In anagen 4, the cortex is keratinizing but has not yet penetrated the inner root sheath.

Pigment donation to cortical cells is evident at this stage.

In anagen 5, the developing hairs shaft finally penetrates the inner root sheath at the level of

the sebaceous duct

Anagen 6 represents the fuly developed follicle. Stage 1-5 of angen collectively known as

proangen and stage 6 as metagen.

Activity is followed by a relatively short transitional phase, catagen, occupying

about 2 weeks in the human scalp and resting phase or telogen. Towards the end of

anagen,scalp follicles show a gradual thinning & lightening of pigment at the base of hair

shaft. The melanocytes in the region of the tip of dermal papilla cease to produce melanin,

resorb their dendrites & become indistinguishable from the matrix cells. The middle region

of the bulb now starts to become constricted. Distal to the constriction the expanded base of

the hair becomes keratinized as a club & below the epithelial column can be seen the dermal

papilla, which becomes released from its surrounding epidermis from the onset of catagen,

the connective tissues sheath of the follicle in particular the vitreous membrane, the thickens

enormously & causes characerstic corrugation of the epithelial strand.

Subsequently the club hair moves toward the skin surface so that the epithelial column

lengthens. After the ascent of the presumptive club, the epithelial strand shortens

progressively from below & finally is reduced to a small, nipple like structure, the

secondary germ . This resting stage telogen,, lasts only a few weeks in the human scalp.

When the next hair cycle starts, the secondary germ elongates by cell divison, grows

Review of Literature

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 11

downward, becomes invaginated by the papilla & gives rise to new bulb, from which arises

the keratinized dome of new hair.

Energy metabolism in hair follicles

It is same as other tissues & organs, hair follicles utilizes glucose via the Emdem-Meyer

hoff pathways, the pentose cycle & the tricarboxylic cycle.

Innervations of the hair

Hair are tactile and are richly innervated.

Blood supply

Is via collaterals from the reticular arteriolar plexus to the dermal papilla & from ascending

branches to anatomsing network around the bulb & inferior augment of the follicle.

Types of hair22

There is no strictly comparable follicles in humans, but these are occasional large so- called

sensory function, they are most numerous in abdominal skin.

Post natal may be divided at the extreme into two kind

1. Vellus , which is soft, unedullated , occasionally pigmented & seldom more than 2

cm

2. Terminal hair, which is longer, coarser & often medullated & pigmented .

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However there is a range of intermediate kinds. Before puberty, terminal hair is normally

limited to the scalp, eyebrows& eyelashes. After puberty, secondary sexual terminal, hair

developed from vellus hair in response to androgens.

Racial & individual variation:

Wide genetically determined variations in the patterns & amount of hair growth can be

observed both races & between individuals. The most striking differences are seen in the

scalp hair. It is common observations that Monogloid tend to have coarse straight hair,

Negroids curly hair,& Caucasoids a range of textures & curl.

According to several authors the macroscopic appearance of hair is related to its cross

section. Thus the Mongoloid hair is the most massive & is circular. Negriod hair is oval &

Caucasoid hair is moderately elliptical & finer than Mangoloid.

Other evidences suggest that the shape of follicle determines hair from, the Negriod follicle

is helical, the mangoloid follicle is completely straight, the Caucasoid follicle varies

between extremes.

However even a straight Caucasoid follicle may produce a hair with an oval cross

section. Significant variations between populations can be shown for a number of the other

measurements auch as medullation, cuticular sacle count, and kinking & average curvature.

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Genetic control

A hypothesis that only 3 ot 4 genes (straight, wavy, apiral & peppercom) control hair form

is not currently accepted. Dyer, while accepting that the genes have major as opposed to

biometric or polygenic effects, concludes that a number of genes are involved.

Changes with age

At puberty, terminal hair gradually replaces vellus, starting in the pubic regions. In both the

sexes the first pubic hair is sparse, long, downy, slightly pigmented & almost straight. It

later becomes darker, coarser, more curled & extends in area to form an inverse triangle.

Seasonal changes

Evidence that human hair growth varies with season has been advanced by several authors.

Scalp

The proportion of scalp follicles in anagen as determined by plucking hair, reached a single

peak of over 90% around march & fell steadily to a trough in September. This pattern

appeared to be shared by all areas of the scalp.

Beard

The rate of beard growth shows that very significant seasonal variation. It was lowest in

January & feburary and from march it increased steadily to reach a peak about 60% higher

in july.

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Thigh

The rate of growth of thigh hair showed similar seasonal pattern to that of the beard. The

mean rate from feburary to march was .27mm/day.

The percentage of the follicles in anagen showed a remarkable & quite different pattern. It

appeared to be lowest in March & August & higher in May/June & November/December.

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REASONS FOR HAIR LOSS

Hormonal influences on hair loss23

In rats , oestradiol, testosterone & adrenal steroids delay the initation of follicular activity

& oestradiol also delays the shedding of club hairs. Conversely, thyroid hormone advances

onset of follicular activity & thyroidectomy or inhibition of thyroid delays passage of moult.

Oestradiol has similarily been to known to delay the onset of follicular activity in the

guinea- pig.

In the rat hypophysectomy advances it, so the influence of gonadal system appears to

override that of thyroid.

The hypothalamus & hypophysis may this exert their influence by way of the thyroid, with

the adrenal cortex & gonads for giving a link between environmental, reproductive &

moulting cycles.

Hormones also influence follicle in anagen. Studies in which rat hair were pulse labelled

with 35

S- cysteine showed that oestradiol or throxine each similarly reduce the duration

actice phase, they being additive when they were administered simultaneously. In contrast

where as oestradiol decreased the rate of hair growth. Thyroxin had the opposite effect.

These findings suggest that the two hormones do not have the same site of action.

Human hair is profoundly affected by thyroid hormones. In studies carried out in

Sheffield. 16 out of 150 women who complained of hair loss were diagnosed as

hypothyroid. Mean hair diameter was reduced. The proportion of roots in telogen has been

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shown to be abnormally high in hair plucked from occipital & parietal areas of hypothyroid

subjects, treatment with thyroid hormone restored it to normal after 8 weeks.

The phenomenon of the postpartum hair loss also appears to result from a hormonally

mediated change in the cycles of scalp follicles. A loss of hair at 2-3 times the normal rate

give rise to transient alopecia about 4-6 months after parturition. At this time , the

proportion of hair in telogen can be as much as 15% where as in late pregnancy it may be

less than 5 % which is only about 1/3.

This suggests that the passage of follicles into catagen followed by shedding of club

hair, is slowed down by pregnancy, but occurs precipitously after parturition when

hormonal conditions are altered, particularly by a rapid fall in oestrogen levels. The pattern

of fluctuation in the anagen/telogen ratio has been observed over 3 consecutive pregnancies

in one subject over a period of 9 years, the change became less marked in each successive

pregnancies.

Androgen Dependent Hair

The growth of obvious facial, trunk & extremity hair in the male & of pubic, axillary hair

in both sexes, is clearly dependent on androgens. The development of such hair at puberty is

, in broad terms & at least initially, in parallel with the rose in levels of androgens from

testicular , adrenocortical & ovarian sources, which occurs in both sexes & is somewhat

steeper in males.

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Substances that causes hair loss24

Allopurinol Androgens

Anticoagulants Antimetabolites

Antithyroid drugs Arsenic

Beta – adrenergic antagonists Boric acid

Captopril- ACE inhibitor Carbamazepine

Chemotherapeutic agents Chloroquine

Cimetidine Cytotoxic agents

Gold Salts Hexachlorabenzene

Lead Mercury

NSAIDS Selenium

Thalium

Abrupt alopecial agents

Arsenic Selenium

Colchincine Vinka Alkaloid poisons

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Thallium poisoning 25

Thallium a toxic metal with atomic no. 81 is located between mercury and lead on the

periodic table. Thallium is a commonly found constituent of granite, shale, volcanic rock &

pyrites (which are used to make sulphuric acid) & is also recovered as flue dust from iron,

lead, cadmium, copper smelters.

In the early 1900’s thallium was medicinally used to treat syphilis, gonorrhoea,

tuberculosis, ringworm of the scalp & as depilatory. Although the usual oral dose given for

epilation in the treatment of ringworm of the scalp was 7-8 mg/kg, fatal dose ranged from 6-

40mg/kg body weight. Many cases of severe Thallium poisoning resulted from this practice.

Toxico kinetics

Exposure usually occurs via one of the 3 routes

Inhalation of dust

Ingestion

Absorption through intact skin

Clinical presentation :

Alopecia is the most common & classic side effect of the thallium intoxication. Typically

seen as a presenting symptom approximately 10 days after an acute ingestion. The total hair

loss usually occurs within a month. Facial & axillary hair, especially inner one third of the

eyebrows, may be spared, but in some cases full beards as well as scalp hair are lost.

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Microscopic studies show thallium deposition as dark brown or black pigmentation located

in the rot of hair samples. These deposits can be seen within 3-5 days of initial exposure. In

patients with chronic exposure, several bands may be noted on the hair shaft demonstrating

multiple exposures. Initial hair growth is very fine & unpigmented, but in patients who

completely recover hair regrowth becomes normal. In patients with severe exposures

alopecia is permanent.

Dermatological effects that have been observed in thallotoxicosis include acne, palmar

erythema of the sebaceous glands.

Microscopic view

Microscopic inspection of hair is felt to yield a diagnostic pattern of black pigmentation of

the hair roots of the scalp in approximately 95% of poisoned patients. However to untrained

observer, this test is unlikely to be conclusive.

Vitamin A Toxicity26

In the skin, vitamin A normally assists epithelial maturation & membrane stability.

However excessive concentrations lead to increased permeability & decreased stability to

lipoprotein membranes. These effects may result from unbound retinal and its esters. In

excessive dosage, decreased keratinisation and sebum production result in extreme thinning

of epithelial tissue, manifested as brittle nails , then rough skin, excessive desquamation and

alopecia.

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Boric Acid27

(H3BO3) is prepared from borax (sodium borate)

After the G.I symptoms, the of patients develop a characterstic intense generalised

erythroderma. Typically extensive desquamation takes place with in 1- 2 days.

Long term chronic exposure to boric acid has resulted in alopecia in adults & seizures in

children

Cytotoxic drugs- teratogenesis

Cytotoxicity is one mechanism of teratogenesis and is characteristic of alkylating or

antineoplastic agents. Aminopterin e.g inhibits dihydrofolate reductase activity and leads to

mitosis & cell death.

If exposure to a cytotoxic agent occurs very early in development, the embryo may die ,

where as sub lethal exposure during organogenesis may result in maldevelopment of

particular structures. There is evidence that following cell death, the remaining cells in an

affected region may try to repair the damage from the missing cellular elements. This

restorative growth may lead to uncoordinated growth & exacerbate the original

malformation.

Caloric deficiency is not considered teratogenic during the period of organogenesis.

However specific nutritional or vitamin deficiencies such as folate deficiency are

teratogenic, at least in animal species.

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METHODS FOR REMOVAL OF HAIR28

Bleaching

Bleaching is actually not a hair removal method, but rather a way to make the hair less

noticeable. This is especially useful for areas that already have thin but dark and therefore

noticeable hair like the arms, face, or neck. Bleaching is performed by applying a chemical

to the desired area, which removes the pigment from the hair.

Hair Removal with Shaving

Shaving is the most temporary method of hair removal because it merely cuts the hair off at

the skin surface. Shaving does not make the hair shaft thicker, darker, or grow faster or

slower. However, the short hair shaft may be more noticeable as it grows out because it has

a blunt tip instead of the normal tapered tip. Shaving should be done after applying some

type of moisturizer to the skin to help the razor glide over the skin, not cut or scrape it.

Common moisturizers include water, shaving cream, hair conditioner, or body wash.

Physical Hair Removal

Physically pulling the hair out of the follicle is a common and fairly inexpensive method of

hair removal. None of these methods changes the color, texture, or density of the hair. The

hair takes longer to grow back because it must grow to the surface of the skin before it is

noticed. Because hair grows at different rates, some of the hair that has been physically

removed may take more time to grow back in. Repeatedly pulling hair out of the follicle

may damage the follicle enough over time to keep it from producing more hair.

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Physical Hair Removal - Plucking

Plucking hair with tweezers is an effective way to remove hair but can be very time

consuming. The hair shaft must be long enough to grasp with tweezers.

Physical Hair Removal - Waxing

Waxing is an effective method of removing large amounts of hair at one time. In this

method wax is warmed to allow it to be spread easily over the skin in the direction of hair

growth. The hair becomes embedded in the wax, which cools and firms up grasping the hair.

The wax is then quickly pulled off in the opposite direction of the hair growth, pulling the

hairs out of the follicles. Cold waxes are available usually attached to strips, which are

patted onto the skin. Wax that is still left on the skin must be peeled or scratched off.

Caution must be used when heating wax so as not to burn the skin.

Physical Hair Removal - Sugar Waxing

Sugar waxing is a popular form of hair removal that works in the same way traditional

waxing does. A thick sugary substance similar to caramel is spread on the skin in the

direction of hair growth. The hair becomes embedded in the caramel. A cloth or paper strip

is patted onto the caramel and then pulled off quickly in the opposite direction of the hair

growth, pulling the hairs out of the follicles. The advantage of this method over traditional

waxing is the clean up. The sugar substance is water-soluble and can be removed easier than

wax by rinsing with water.

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Hair Removal with Depilatories

Depilatories use a chemical called thioglycolate mixed with sodium hydroxide or calcium

hydroxide to literally melt the hair away. Thioglycolate disrupts disulfide bonds, which are

chemical bonds that hold skin and hair cells together. The disulfide bonds that hold hair

together contain more of the protein cystine than do the disulfide bonds that hold skin cells

together. Thioglycolate is more effective on disulfide bonds that contain cystine. The major

side effect of a depilatory is skin irritation because the chemical can melt away skin cells.

A depilatory is applied to the area with unwanted hair and left on for 3 to 15 minutes.

During this time the chemical dissolves the hair and the resulting jelly-like substance is

wiped or washed off after the appropriate time. The chemical should be tested first on a

small skin area at least 48 hours before applying it to a large area. Applying a

hydrocortisone cream after hair removal may help decrease irritation.

Hair Removal with Electrolysis

Electrolysis involves inserting a fine needle into the hair follicle and applying an electrical

current to the follicle root. This procedure actually burns the hair root theoretically

preventing it from producing more hair. Each hair follicle must be treated individually and

may take several treatments to destroy the follicle. Electrolysis is a permanent form of hair

removal but it has several drawbacks. First, there are no standardized licensing guidelines

for electrolysis so finding an experienced, effective technician is difficult requiring talking

to clients who have experienced permanent results. Second, this method requires repeated

treatments for up to 12 to 18 months. Hair follicles that are in the telogen phase are more

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difficult to destroy than hair follicles in the anagen phase. Shaving approximately 3 days

before an electrolysis treatment ensures that the hairs that are visible are in the anagen

phase. Finally, side effects can include pain, infection, keloid formation (for people who are

susceptible), hyperpigmentation, or hypopigmentation.

Hair Removal with Laser

Laser treatment of various skin conditions has blossomed, as laser technology has become

more understood. Hair removal is a common application of laser technology, but it is not

permanent and not for everyone. Lasers work by emitting light at various wavelengths,

energy output, and pulse widths. The wavelength used determines the skin structure it will

affect such as veins, melanin, or water. Most lasers used for hair removal target melanin and

are therefore designed to burn structures that contain melanin. The more melanin, the more

damage. It makes sense that laser hair removal works best for light-skinned people with

dark hair. As with electrolysis, hair follicles in the anagen phase are more easily destroyed

than those in the telogen phase. Therefore, laser treatments for hair removal must be

repeated. At this time it appears that laser treatment, while not causing permanent

destruction of all hair follicles, does retard the regrowth of new hair.

Hair Removal with Vaniqa

Vaniqa is a prescription-only topical cream that has been FDA-approved for reducing and

inhibiting the growth of unwanted facial hair. The active ingredient in Vaniqa is eflornithine

hydrochloride, which has been used to treat African sleeping sickness and certain cancers.

Vaniqa works by inhibiting an enzyme that is needed for cell reproduction and other cell

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functions necessary for hair growth. Vaniqa is applied twice a day to areas of unwanted

facial hair. Noticeable results are usually observed after 4-8 weeks of therapy. Application

must be continued for as long as inhibition of hair growth is desired. Vaniqa continues to

reduce facial hair growth for up to 8 weeks after discontinuing treatment.

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BAHAYA KALPANA

Formaulations intended for external use

As mentioned in ayurveda, the treatment is of two types Viz.29

Antahaparimarjana

Bahiparimarjana.

The later one called Bahiparimarjana means , the medicine , intended for the

external use only. For that purpose in Ayurveda different forms of treatment are

mentioned for the different diseases. They are, Lepa kalpana, Upnaha,

Malaharakalpana etc. As mentioned in Modern Pharmaceutics , ointments, creams,

pastes, jellies etc. , external applicants.

Lepa kalpna

Synonyms:30,31

Alepna(topical application.) Lipta

Lepa Lepana.

Medicine in the form of a paste used for external application are called lepas. The drugs are

made in to a fine powder form. Before use on the body, it is mixed with some liquid or other

medium indicated in each preparation and made into a soft paste. Water, cow’s urine, oil,

ghee etc can be used for mixing.32

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Dry medicinal drugs are made into kalka(paste) form by adding little quantity of water and

grinding . this kalka is used as external application and it is called lepa kalpana.

Pharmaceutical lepa kalpana is a form of kalka kalpana.

Importance of lepa kalpana in Sushruta Samhita , in the context of Varna and shopha

treatment alepa is given prime importance.

While explaining the efficacy of the lepas it is mentioned that, by pouring water, over a

burning house , how the fire is get stopped immediately , same manner by application of

lepa provoked dosas of vrana(vedana, sotha etc complications of vrana) will get subsided.

Lepa is having actions like shodhana, utsadana, ropana etc.33,34

Different scholars of Ayurveda have mentioned different types of lepas on the

basis of the drug used for preparation , mode of administration , and its usage.

According to the Acharya Sushruta Varitiesof lepa35,36

1. Pralepa 2. Pradeha 3. Alepa

According to the Astanga Samgraha, Varities of lepa37

1.Snahika 2. Nirnapana 3. Prasadana

4 Stambana 5. Vilayana 6. Pachana

7 .Pidana 8. Sodhana 9. Sosana

10.Savarni karana

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Among these , first five types are most useful formulations for the treatment of vrana sotha

rest of the five lepas are useful for the treatment of secondary stage of Vrana.

Acharya Sharangadhara concept regarding lepa kalpana.38,39

On the basis of the drugs used for the preparation of the lepa kalpana and their action , he

classified lepakalpna as follow.

Lepakalpana is of three varities. Viz:

1. Doshaghanlepa

2. Vishaghnalepa

3. Varnyamukha lepa.

Acharya Sushruta has advised incorporating of sneha dravya in lepa formulation according

to doshas.40,41,42

Table no.04- showing quantity sneha dravya in lepa formulation according to doshas.

S.no Dosha Sneha dravya quantity

1 Vataja vyadhi 1/4th

part

2 Pittaja vyadhi 1/6th

part

3 Kaphaja vyadhi 1,8th

part

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Technique & Rules of application of the lepa

Lepa applications should be gently rubbed in an upward (pratiloma) or reverse direction as

of the hair over the skin to make the action of the application quick and effective. Because

of application enters into romakupa and further get absorb through swedacahasrotas &

Siramukha to produce good results.43,44,45

The lepa should not be left in situ after drying. It must be removed as soon as it dries up.

Because lepas in wet state help to cure the diseases, where as on drying they lose their

potency and irritate the skin.46

Over the previous lepa, fresh one should not be applied.47,48

Table no05:- thickness of the lepas while application mentioned by Acharya

Sharangadhara49,50

S.no Types Thickness

1 Doshagna ¼ anguli

2 Vishagna 1/3 anguli

3 Varnya ½ anguli

On the basis nature of the lepa and its thickness etc. Acharya Sharangadhara has again

classified lepakalpana as51,52

Pralepa

Pradeha

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Pralepa is that which can be applied cold, thin and which dries quickly, where as pradeha is

applied warm , thick and remains moist for a long time.53

The thickness of the pralepa and pradeha applications on the skin should be equal to the

thickness of a buffalo’s skin.54

Time of application of the lepa :

Pralepa should neither be applied at nights nor it should be allowed to stay on after it dries

up, where as pradeha can be allowed to stay (even after drying) in order to cause pressure

over that part of the body.55,56

The heat of the body comes out through skin pores at nights normally, if the medicinal

applications are done at nights the skin pores get blocked and obstruct the transfer of the

body heat. So external applications should not be done at nights.57,58

But in case of apakava shotha, gambhira shotha and shotha arising from rakta

and sleshma, applicatons can be made even in nights.59,60

Specifications to be followed while application of lepa:

Lepas are effective so long as they are moist and once they are dry up , they will harm the

skin.61,62

Preservation of the lepa.63

Herbal lepa churna will preserve in air tight container – 30 days

Mineral and metallic preparations in air tight container- last indefinatley.

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DRUG REVIEW

HARTALA

In Rasa classics, majority of Acharyas place it in Uparasa group64,65,66,67,68

Historical review

Hartala is being used in field of treatment since the beginning of pre-historic period.

Vedic literature is having certain reference of Hartala and its description regarding the use

for different purposes. Rigved has given the use of Hartala in creating artificial rain. In

Athervaveda Hartala is used for treating sexually transmitted diseases.

Among Brihatrayis, in Charaka samhita, Hartala has been used for treatment of

kusta, unmaada, swasa, kaasa, in visha, for external application in skin diseases and for

mrudu virechana.

Acharya (Susruta) has used Hartala in treatment of upadamsa, arsha, kshudra rogas.

It is also used for the purpose of vranashodhana, lomashatana, savarnata karana. It is also

used for eye, ear and in grahapida diseases.

Other Acharya (Astanga Hrudaya) used it in the treatment of kusta in varana

curnana, lepa and in oil preparation, in nasaroga for nasavarti etc.

Acharyas of later period have followed Brihatrayis and they have increased the use

of Hartala.

Mythological Origin

In Rasendra Purana story is available viz. Hartala is derived for the first time when Lord

Narsimha had been destroyed the evil Hiranyakasipu, at evening time69

When

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Hiranyakasipu was dying, he had vomited and this vomited material was converted into

orpiment which was being remained in this armpit70

.

According to Basavarajeeyam, when Hiranyakasipu was being killed by Lord

Narasimha, a product similar to his kanti (lusture) called Talaka was produced when

Lord Narsimha pinched the arm pit (Kaksha) of Hiranyakasipu.

Vernacular names 71

Sanskrit - Harataala Kanada - Haritaala, Ardala

English - Orpiment, Yellow Arsenic Odiya - Haritaal

Arabi - Jarnikhasfer, Ursanigum Assami - Haritaal

Persian - Zarneik-Zard Tamil - Aridaram

Parsi - Jarnikhejarde Marathi - Haritaal

Burma - Hsaydanshwywa Hindi - Haratal

Canarese - Ardal Bengali - Haritaal

Duch - Harataala Gujarati - Ardal

Malayalam - Aritaram Punjabi - Haritaal

Konkani - Ardala Sinh - Aridal

Latin - Auripigmentum / Arsenic Trisulphidum

Telugu - Doddi Pashaanam

Table no. 06- Synonyms of Hartala

S.NO SYNONMS A.K R.S.S Ba.Ra R.T Rm Sidd.Mish

1. Haratala _ + + + _ +

2. Haratala + _ _ _ + +

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3. Tala _ + + + + +

4. Talaka + + _ + _ +

5. Ala _ _ _ + + +

6. Alam _ + _ _ _ _

7. Godanta _ _ + _ _ _

8. Godanti + _ _ _ _ _

9. Shailabhushana _ + _ _ _ _

10. Shailooshabhushana _ _ _ + _ +

11. Natabhushana _ _ + + _ +

12. Natamandana + _ _ + _ _

13. Natamandanaka _ _ _ _ _ +

14. Chitra Gandha _ _ _ + _ +

15. Ati Gandha + _ _ _ _ _

16. Visra Gandha _ _ + _ _ _

17. Malla Gandha _ _ _ + _ +

18. Girijaalalitam + _ _ _ _ _

19. Romaharana _ + _ _ _ +

20. Pinjara _ _ + + _ +

21. Pinjakam _ + _ _ _ _

22. Pindaalakam _ _ + + _ _

23. Vidaalakam + _ _ + _ +

24. Vamshapatraka _ _ _ + _ +

25. Vangaari _ _ _ _ _ +

26. Peeta + + _ _ _ _

27. Peetanakha _ _ _ + _ +

28. Kanakhaprabha _ _ + _ _ _

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29. Karchura _ _ _ _ _ +

30. Kharjura _ _ _ _ _ +

Occurance72

The chief source is Iran and it is also found in Burma and China. In India, it is found

in U.P . Artificially it is prepared by heating arsenic and sulphur together, in anaerobic

condition. Orpiment occurs in the oxidized portion of arsenic veins. It is associated with

antimony ores in as viens.

Table No 07 – 2 Types Of Hartala73,74,75

S.NO REFERENCES TYPES-ENUMERATION

1. R.sar 7/74; R.S.S 1/168 Patala Hartala Pinda Hartala

2. R.P.S 6/2 Dalakya Hartala Ashma Hartala

3. A.K 1/48; Ra.Chu 11;

R.R.S 3/64; R.T11/4;R.K;Ba.Ra25;

R.cham; Rm; R. pad.

Patra Hartala Pinda Hartala

Table No.08 . Showing the difference of main two types: Patra and Pinda,76,77,78

PATRA HARTALA PINDA HARTALA

Golden colour Yellow colour

Lusterous No Luster

Thin layered No layer

Heavy Less heavy

Beautiful Not good in appearance

Smooth Rough

Qualitatively better Lesser

Rasayana Stripushpahara

Tridoshaghna Swalpa satva

Kustaghna Stone like structure

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Characters of individual varieties :

Grahya lakshana79,80,81

:

1) Patra Hartala

It is heavy, shiny and yellow in colour is looks like Gold.

Several small and thin layers are attached seen in Patra Hartala.

It is soft and smooth in texture.

Chemically contains Sulphur and arsenic.

It has the property of Rasayanam and generally used in medicine.

2) Pinda Hartala

It looks like a Pinda.

Several small and thin layers are not seen in Pinda Hartala.

It is heavy and hard.

It is used as medicine for leucorrhoea.

3) Godanta Hartala

It is heavy and large in size.

It is very smooth and looks like Godanti. At the center yellowish blue lines are seen.

4) Vakadala Hartala

It is very smooth like ice surface, patrayukta and heavy.

This type of Hartala Cures Leprosy.

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Table no09- Ashodhita hartala sevana doshas

NAME OF THE TEXTS

TOXIC

SYMPTOM

BP RR

S

A.P R.

Chu

R.

K

Y R RSS BR RT RM RJN

Anga diptihara _ _ _ _ + _ _ _ _ _ _

Anga sankocakara + + + + _ + + _ _ + +

Arucikara _ _ _ _ + _ _ _ _ _ _

Asmakara _ _ _ _ + _ _ _ _ _ _

Atughnam _ + _ + _ + + + _ + _

Balahanikara _ _ _ _ + _ _ _ _ _ _

Dahakara _ _ _ _ _ _ _ _ + _ _

Dehanasaka _ _ _ _ _ _ + _ _ _ _

Kampakara _ _ _ _ _ _ _ _ + _ _

Kapharogakara + + + + + + + + + + +

Ksobhakara _ _ _ _ _ _ _ _ + _ _

Kusthakara + _ + _ + _ _ _ + _ _

Mehakara _ + + + _ + + + _ + +

Murchakara _ _ _ _ + _ _ _ _ _ _

Malinikaroti anga _ _ _ _ _ _ _ _ + _ _

Pangutva kara _ _ _ _ _ _ _ _ _ _ +

Pidika kara _ _ _ _ _ _ _ _ _ _ +

Sphotakara + + + _ _ + + + _ + _

Tapakara + + + + + + + + _ + +

Todakara _ _ _ _ _ _ _ _ + _ _

Vatarogakara + + + + + + + + + + +

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Management Of Toxic Effects Of Hartala:

Antidote 82

Jeeraka + Sharkara for three days.

One of the juices of Javasa, Kushmanda and Rajahamsa three times a day.

Table no. 10 – Pharmacological properties of hartala 83,84,85

RASA PANCHAKA PROPERTIES

Rasa Katu,tikta ,kashaya

Guna Snigdha, Guru

Veerya Usna

Vipaka Katu

Doshaghnata86

– Kapha vatahara

Rogaghnata87,88,89,90

– Kushta, Visarpa, Jwara, arsha , apsmara.

Rasamadhava says that the use of talaka results in hair fall.91

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Table No 11– Shodhana Of Hartala

SWEDANA

S.No REFERENCE DRAVYA DURATION

1. R.sar Kushmanda swarasa 100 times

2. RM 3/70; Ra.Sam;

Ra.Sara

Kushmanda swarasa, Churnodaka & Tila

Taila

Each 1 Yama

3. A.K1/55-56

RaChi7/75-76

R.S.S1/173;

Kanji, Kushmanda swarasa, Tila Taila,

Triphala Quatha

Each 1 Yama

4. RRS 3/70;

R.P.S 6/4

Kushmanda swarasa /

Tila kshara jala / Churnodaka

1 Yama

5. RRS 3/71;

A.K 1/53

Hartala + 1/10th

Tankana are washed with

Jambeera rasa & kanji, tied in pottali and

boiled in mixture of kanji and lime water.

1 Day

6. R.S.S 1/171-172 Hartala + 1/10th

Tankana are washed with

Jambeera rasa & kanji, tied in pottali and

swedana in kanji, later in Kushmanda

swarasa or Shalmali rasa

Each 1 day

7. Ba.Ra.15 Hartala + 1/10th

Tankana are washed with

Jambeera rasa & kanji, tied in pottali &

swedana for 1 yama each Tila Taila &

Triphala Quatha. Later bhavana for 3

times with Gomutra & Kanji

Whole

process

for 12 times

8. RRS 3/73;

A.K 1/53

Kushmanda swarasa / Shalmali Toya 1 Day

9. RT 11/18 Nimbu rasa & Griha Varina Each 1

Prahara

10. RT 11/19

Kushmanda swarasa then in Churnodaka

or Triphala kashaya

1 Yama

11. Rasayana Sara Taila, Takra, Gomutra, Kanji & Kulattha

Quatha

Each 1 Yama

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12. RT 11/21 Tila kshara jala, Shalmali mulaswarasa 1 prahara

BHAVANA

13. RT 11/22 Shalmali mulaswarasa 1 Time

14. RT 11/25 Churnodaka 7 Time

Table No 12 – Shuddha Talaka Guna

S.No GUNAS A.K Rm RRS RPS R.

Ch

RSS Ba.

Ra

Ra.S

am

R.T

1. Kandu Hara + _ + + _ _ _ _ _

2. Kusta Hara _ _ _ _ _ _ _ + _

3. Mrutyu Hara + + + + _ + + + +

4. Jara + + _ _ + + _ _ _

5. Nashanam Sowbhagya + _ _ _ _ _ _ _ _

6. Sowgandhya + _ _ _ _ _ _ _ _

7. Parama AyuVardhaka + _ _ _ _ _ _ _ _

8. Jara Nashaka + _ _ _ _ _ _ _ _

9. Kanti Vardhaka _ + _ _ _ _ _ _ _

10. Veerya Vardhaka _ + _ _ + + _ _ _

11. Ojo Vardhaka _ + _ _ + + _ _ _

12. Deepaniya _ _ _ _ _ + _ _ _

13. Kapha Vata Hara _ _ + + _ _ + _ _

14. Rakta Dosha Hara _ _ + + _ _ + + _

15. Arsho hara _ _ + + _ _ + + _

16. Bhoota Hara _ _ _ _ _ _ _ + _

17. Visha Hara _ _ + + _ _ + _ +

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18. Jwara hara _ _ + + _ _ + _ _

19. Visarpanut _ _ _ _ _ + _ _ +

20. Rujaapaham _ _ _ _ _ + _ _ _

21. Twachya _ _ _ _ _ _ + _ _

22. Rasayana _ _ _ _ _ _ _ _ +

23. Sreshta + _ _ + _ _ + _ +

Table No13- Marana of Hartala

S.NO REFERENCE BHAVANA DRAVYA YANTRA DURATION

1. A.K Dwi.Prath.

57-58;

R.R.S 3/71-72;

Ba.Ra.15

Palasha mula kashaya

(thick like Honey) -3

Bhavanas

Buffalow’s urine -1

Bhavana.

Chakrikas are

prepared & placed in

sharava samputa.

10 Vanopalas;

repeated

for 12 times

2. R M 3/71 1 Pala of Hartala –

Bhavana with Kumari

Swarasa

Chakrikas are

prepared & placed in

sharava samputa.

12 Yama

Pachana

3. R.T11/26-29 Punarnava Rasa Punarnava Kshara

Purana in Sharava

Subject

to Agni

4.

R.T11/30-34

5 Tola – Pippali Twak

Quatha

In Bhasma Yantra –

Agni for 4 Prahara

21 Times

5. R.T11/35-38 Arka Ksheera

Palasha Kshara

In Bhasma Yantra –

Agni for 4 Prahara

Swetha

Bhasma

6. R.T11/39-41 Equal parts of

Hartala+Mukta bhasma –

Kumari Swarasa

Sharava Samputa –

Puta

1 Laghu Puta

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Table No 14– Talaka Sattvapatana of Hartala

All texts have enumerated Talaka Sattva patana, but only few texts have explained both

haratala marana & Sattva patana. Satva is white in colour.

S.N REF. METHOD YANTRA

1. R.sar Vyadhighata phala Kshara, Kushmanda rasa & Punarnava

ras – bhavana for 7 days each. 1/4th

part each of above &

puta to be given

Pathana

Yantra

2. A.K.

Dvi.Pra.59

Laksha, Rajee, tila, Shigru, Tankana, Lavana, Guda – all

equal parts is mixed well & taken half of the quantity of

Hartala and subjected to Puta.

Patala

Yantra

3. A.K.

Dvi.Pra.60

Bhavana with Sarpakshi Ksheera / Kashaya – subjected to

puta.

Patala

Yantra

4. R.R.S

3/73-76

Kulattha Quatha + Solu of tankana + Mahisha Ajya+

Madhu – Chakrikas – 4 yamas till bluish yellow fumes

comes out. strong heat for one prahara

Chidra

Yukta

Sharava

5. R.R.S

3/77-78

Arka Ksheera bhavana for 1 day. 1 tola Tila tail bhavana.

Then heat for 7 prahara till white coloured sattva is

obtained.

Glass

bottle

6. R.R.S

3/79-81

Equal quantities of Chaga Mamsa + Hartala – for 2 days.

Bhavana with Dravaka gana – Kupi pakva for 12 prahara –

white coloured talaka Sattva near neck of bottle.

Glass

bottle

7. A.K.

Dvi.Pra.62

-63

Hartala + Laksha + Rajee + tila + Shigru + Tankana +

Lavana + Guda – all equal parts. Bhavana with Arka/Snuhi

Ksheera/ Kushmanda rasa and subjected to Puta.

Chidra

Yukta

Musha/

Patala

8. R.R.S

3/82-84

Pottali is prepared with ½ Pala Hartala. Lepa with

Gandhaka triturated with lemon juice. Pottali is dipped in

12 Tola of melted Tamra. Later Hartala Sattva is collected

from pottali.

Pottali

9. A.K.

Dvi.Pra.64

Hartala 1 part, 1/8th

parts of Parada & Tankana – Bhavana

with Kushmanda Swarasa/ Arka/Snuhi Ksheera.

Chidra

Yukta

Musha

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Hartala Bhasma pariksha 92

When Hartala Bhasma is heated over fire it should burn without smoke.

Dose of Hartala Bhasma 93

The Dose of Hartala Bhasma is ¼ to ½ Ratti.

Pathya 94

Lavana, Amla, Katu Rasa, should not be taken and Exposure to Vahni and Atapa

should be avoided.

Therapeutic properties of Hartala Bhasma 95

Phiranga

Vipadika

Vishamajwara

Bhagandara

Visphota

Vatarakta

Vicharchika

Phirangajanya Roga

Vrana

Vatarakta etc

Visarpa

Different types of Kushta

Apasmara

Nadivrana

MODERN ASPECT OF HARTALA96

(ARSENIC TRI SULPHIDE)

Introduction

Hartala is equated with orpiment or arsenical gold and are chemically known as

Arsenic Tri Sulphide.

Arsenic trisulphide is a naturally occurring form of trivalent arsenic. As orpiment is

one of the major arsenic-containing mineral. It is also manufactured from the reaction of

arsenic trioxide with Sulphur and is available commercially.

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It is used as a pigment under the name kings yellow. It is Element from group 5A.

Arsenic Trisulphide is insoluble in water and poorly absorbed. It is therefore represents

much less of an acute toxic hazard than soluble arsenic compounds.

History

Its name in Greek word Arsenikon meaning Yellow Orpiment.

Two sulphides of Arsenic were used in Ayurvedic system of medicine under the

names recognized as Realgar and latter as orpiment (corruption of Latin,

Auripigmentum gold paint).

A German alchemist Albert, count of Boll stadt (aka Albertus magnus) discovered it

in 1256 A.D.

Occurrence

Arsenic is almost invariably found in small quantities in the sulphide ores of most of the

metals e.g.

Arsenical iron FeAs2 Arsenical nickel NiAs Cobaltite CoAsS

Its most important minerals are

1. Arsenical pyrites or mispickle, FeAsS

2. OrpimentAs4S6 and Realgar As4S4

3. Cobaltite CoAsS

4. Nickel glance, NiAsS

Arsenic is not available in India in abundant quantity. It occurs in Czecho-slovakia,

Rumania, Macedonia, Asia Minor, Kurdistan, Japan and U.S. A.

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Basic information of Arsenic Trisulphide

Origin

As the ore orpiment Reaction of arsenic trioxide and Sulphur

Chemical group : A compound of Arsenic, a group of 5 A element.

Physico-Chemical properties

Chemical structure : As2S3.

Molecular weight : 246.04.

Physical state at Room temperature: Solid.

Hardness : 1.5-2

Specific gravity : 3.4-3.5

Optic angle : About 70o optically +ve strong dispersion

Luster : Pearly elsewhere resinous

Colour : Lemon Yellow of several shades

Odour : None

Streak : Lemon Yellow of several shades but

paler sub transparent to sub translucent

Solubility : Insoluble in water.

Chemical interaction : Aqueous solutions react with active metals

to produce arsenic gas.

Major products of Combustion: Arsine and hydrogen sulphide fumes are produced.

Flammability : Combustible.

Boiling point : 7070C

Melting point : 3100C.

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Density : 3.43.

Composition : As – 60.90%. S – 39.10%

Class : Sulfide.

The Mineral is non –conductor of electricity.

When sublimated in the closed tube yellow gas is formed.

When heated to 1000C it becomes red, it however resumes its original colour on

cooling but when heated to 1500C the change is permanent.

Extraction

It is commercially obtained by roasting its Sulphide ores & subsequent reduction

with carbon of the arsenious oxide.

As4S6 + 9 02 As4O6+6 SO2

As4O6 + 6 C As4+6 CO

Pharmacology

Externally : Arsenic is a local irritant acting slowly on tissue producing inflammation.

Internally it acts on Gastro intestinal tract : In small therapeutic dose it increases the

vascularity of gastro intestinal tract by dilating the capillaries. Where as in large dose it is a

powerful gastro–intestinal irritant.

Heart and circulation: Affect on mammalian heart is minimum but on poisoning, the

muscles are directly depressed. The capillaries dilate enormously and the blood pressure

falls.

Blood: Arsenic increases the vascularity of the bone marrow and alters the cellular

composition of blood.

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Kidney : Arsenic in toxic doses may produce severe renal damage. The urine contains

albumin, and red blood cells.

Nervous system: Actually no special action on the nervous system is elicited by arsenic in

acute poisoning. In chronic poisoning, symptom of peripheral neuritis develops with limited

areas of paralysis.

Skin: Arsenic has a presumed effect on the nutrition of the skin. It improves the complexion

and cutaneous nutrition and increases the subcutaneous fat. It is eliminated with the sweat

and causes itching and eruptions. In chronic poisoning skin rashes are common and are due

to direct action on the skin. These effects may be due to cutaneous vasodilatation. The most

characteristic action is the darkening of the skin “ Arsenical Melanosis”.

Absorption : On an average daily intake of arsenic by human being is half to one mg

through food and water. On absorption of arsenic bounds to protein portion of the

Haemoglobin. Absorption of arsenic is either orally (pentavalent arsenic), dermally

(arsenite), by inhalation (arsine), or parenterally.

Distribution: Absorbed arsenic is distributed to all body tissues. High concentrations would

be expected in keratin rich tissue such as hair, skin and nails due to sulphydryl group

binding.

Excretion : It is eliminated mainly by the kidney, in the form of mehthylated arsenic but

also in feaces, bile, sweat, milk and other secretions.

Antidotes :

Antidotes of arsenic poisoning are

Chelating agent used against arsenic poisoning is dithiol compound, which can

remove arsenic from endogenous sulphydryl groups, the targets of arsenic poisoning.

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Traditionally, dimercaprol (British anti lewisite, BAL) has been recommended

chelator in arsenic intoxications.

SHANKHA:

Shankha is known to Indians since many days. Charaka explained Shankha in 27th

chapter

of Sutrasthana under Varishaya varga97

Sushruta also explained it in various places as a

medical use.

Rasarnavakar considered it under shukla varga. It is a Molluscan species and it is

also identified as sacred chank or conch. Conch is a large sea snail with a heavy spiral shell.

The shell varies widely in colour from white through pink, yellow & orange, and has

hornilike knobs. The flesh of the queen conch is valued as food .

In India, in ancient times, the blowing of conch shells was practiced at wars, to

frighten the enemy. It is believed that blowing of conch shell averts the evil powers. The

external shell is formed as a spiralled out extension of the inner core and mainly formed of

Calcium carbonate98

Vernacular Name99

Sanskrit -Shankha Tamil - Sanka

English -Conch shell Telugu - Sankham

Hindi -Shankh Kannada - Shankha

Bengali -Sankh

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Chemical Composition -Calcium Carbonate (CaCo3)

Source100

Indian ocean coasts. It is the outer covering of “ Mollusca group” of aquati animal

which are seen in sea. It is collected from the sea, and put in boiling water. The animal

which is present inside dies and the outer portion is Shankha, it is sold in market.

Shankhas are gregarious and exclusively marine animals occurring in large numbers

on muddy sand bottom Thirteen meters in depth in Tamil nadu shores and Andaman waters.

Swaroopa101

:

The Shankha having Vrinta, singdha, sukshma Mukha, sundara, Nirmala and guru in

nature is considered to be the best.

Characters102

:

It is a porcelaneous shell of an oblang or conical form. The oblong form is bulged in

the middle and tapering at each end the conical variety is peculiar. The upper portion is like

corkscrew, twisted and tapering at the end. The base is broad, the interior is hallow. The

surface is hard and dull white colour. The upper surface is highly tuberculated, the under

surface shining, very brittle and translucent.

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Synonyms:

Table No.15 Showing synonyms of Shankha 103,104,105,106

Synonyms RT AP RRS RSS

Shankha + + + +

Shankaka + - - -

Kambu + + + +

Trirekha + - - -

Samudraja + + + -

Sunada + - - -

Deerganda + - - -

Kamboja + - - -

Kshudra - + + -

Shankanaka - + + -

Pavana dhwani - - - +

Mahanada - - - +

Haripriya - - - +

Varieties107

:

Two varieties of shankha are mentioned in Ayurveda prakash. One is

Dakshinavartha and another Vamavartha. Dakshinavartha is said to be more sacred, uttama

and is widely used for medicinal purposes. Vamavartha is madhyama can also be used for

medicinal purposes.

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Shankha

Dakshinavartha Vamavartha

Shodhana 108,109,110

The shankha is made into pieces and these are tied into pottali and boiled in Jambira

swarasa for 4 Yamas i.e., 12 Hours. After that pottali should be removed and pieces should

be washed with hot water.

Jayanthi swarasa swedana Dolayantra

For 3 hrs

Tanduliya drava 3 hrs Dolayantra

Swedana

Kanji 3 hrs Dolayantra

Pachana

Nimbukamla ½ Yama Dolayantra

Pachana

Amla dravya Swedana Dolayantra

+ in kanji

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Marana of Shankha111,112,113

:

Pieces of shodhita Shankha are dried well, then these are placed in sharava samputa,

after that sandibhandhana should be done. After complete drying it is subjected to gajaputa.

After obtaining from puta the pieces are powdered. It is then given the Bhavana of Kumari

Swarasa and once again subjected to gajaputa. Such 2-3 putas yield good white bhasma of

Shankha.

The pieces of shodhita shankha are put into the fire and subjected for samyag laghu

puta till they become bloomed.

One pala of Shankha, killed by being heated in a blind crucible is to be rubbed by

means of a rod with half a masha of Tankana and used in medicines.

Pharamocological Properties114

Rasa : Katu rasa (Kshara).

Guna : Lagu, Sheeta.

Veerya : Sheeta.

Karma : Grahi, Balya, Vilekhana, Agni deepana, Vishagna, Varnya, hridya.

Rogaghnata

Table No.16 Showing Rogaghnata of Shankha 115,116,117,118,119,120

Rogaghnata R.T A.P R.S.S B.R.R.S R.N Y.R

Amlapitta + - + - + -

Grahani + + - + + +

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Parinamashoola + - - - - -

Tarunyapidika + + - + - +

Netrapushpahara - + - - + +

Gulma - - + - - -

Swasa - - - - - -

Meha - - + - - -

Udara shoola - - + - - -

Modern view

Calcium carbonate:

Calcium carbonate occurs in large quantities in nature as chalk, marble and lime

stone. However enough CaCo3 is observed to cause systemic and renal effects but it has

mainly considered to be the non systemic antacid121

Absorption And Excretion122

Caco3 Ca+2 Co3

-2

H2O+

H2CO3 H2O+CO2

The calcium cations formed in reaction and present as the water soluble Calcium chloride

salt can be either absorbed or precipitated as the insoluble Calcium phosphate salt in the

intestine or as in soluble Calcium soaps from the Hydrolyzed glycerides resulting from

digested food. Calcium excretion varies directly with the creatinine clearance.

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Preparation123

:

It is obtained in the laboratory by the action of soluble carbonate on a Calcium salt

or by passing CO2 through time water.

CaCl2 + Na2CO3 CaCO3 + 2Nacl

Ca (OH)2 + CO2 CaCO3 + H2O

Untoward effects124

:

Constipation and chalky taste of Calcium carbonate are clinical disadvantages,

Nausea is an occasional complaint and mere seriously infrequent instances of hypercalcimea

with alkolosis, caleinosis and azotemia occur during chronic calcium carbonate usage.

Contraindications:

Patients with renal disease, history of calculi, gastro intestinal haemorrhage,

hypertension or dehydration and electrolyte imbalance due to excessive vomiting.

Properties125

:

It is soluble in water containing Carbon dioxide forming calcium bicarbonate.

CaCo3 + H2O + Co2 Ca (HCO3)2

It is fine, white, odorless, tasteless, microcrystalline powder which is stable in air.

It is insoluble in alcohol, water and dissolves with effervescence in diluted acetic,

diluted hydrochloric and diluted nitric acids.

Uses:

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It is used as Diuretic, emmenogogue, Astringent, Antacid, local sedative and

antiseptic.

For the manufactures of lime.

As a flux in the smelting of ores.

In the preparation of tooth pastes and face powder.

PALASHA

We have got the references of use of ‘Palasha’ since Vedic period and Samhita

period.126

Charaka Samhita

Leaf, flower, skin, seed and kshara are the parts used in differentyogas. Palasha is

used in kasa, Grahani, Arsha, Udararoga, kushtha and in skin diseases.

Sushruta Samhita

Utility of Palasha in kushtha, Gulma, Udara Roga, Arsha, Bhagna, Netraroga.

Sharangdhar Samhita : According to Sharangdhar, Palasha seed is used in 'Loha

Rasayan' 'Yoni Sankochanarth lepa. Kshara of Palasha is used for kesha Nirharana

lepa and for Netra prasadana vidhi. Kshara is used in romashatana.

Description Of Plant127

Palasha is sacred tree (Putadru) used in religious rituals and sacrifices (Yajnika,

brahmavruksha, Samidvara), It grows widely (Vanaprastha) has characteristic leaves

(Palash, parna) with three rough leaflets and curved (Kharaparna, triparna). Flowers are red

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(rakta puspaka) and curved (Vakrapuspaka) typical of papilinate resembling parrot's beak

(Kimshuka). Seeds are oily (bijasneha) and make a potent anthelminthic drug (Krimighna).

It also pacify vata (vatahara). The plant is one of the best among the sources of alkalies

(Ksharasrestha).

Vernacular Names:128

Sanskrit - Palasha

Hindi -Dhaka, Tesu, Palas, Chichra, Dhara, Faras Kankeri, Chini agond

Latin Name - Butea monosperma

Bengali - Palash, Ganch, Kamarkas

Marati - Palasa.

Gujarati Khasathi Khakra.

Tamil Paras, Patsan, Camala, Paladula Modug Mooduga.

Telagu -Modhung, Midug chettu.

Kannada -Muttuga, Muttala, Muttagamara.

Malayali -Palashin Samatha, Camata, Pilacham, Muraklamar

English -Flame of the forest, parrot tree, Judas tree (Myths.and traditions)

Persia -Palah

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Synonyms

palasha bramhapadka palashka

kinshuka krimigana ksharshreshtha

kashthaka tripatra suparni

putrdu bijasneha bramhavriksha

vakrapushpa vatahar vanprastha

vatpoth raktapuspak pruthushimbhi

Bheda: 129,130,131,132

Madanpal - Rakta, Peeta, Shweta and Neela

(According to colour of the flowers)

Abhidhanmanjiri - 1) Palasha 2) Valli Palasha

Shaligram - 1) Kinshulaka 2) Hastikarnaka

According to Raj Nighantu - Rakta, Peeta, Shweta and Neela

Table no. 17- Pharmacological properties of Palasha

Rasa Guna Veerya Vipaka Doshaganta

Titkta Laghu Ushna Katu kaphaghana

Katu Ruksha Vataghana

Kashaya Snigdha Pitakara

Pharmacological actions of Palasha:

Deepan Vrushya Krimihar Sangrahi

Drug Review

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Sarak Vranahar Gulmahar Grahani

Arshya Kusthahar Rasayan Veeryavardhak

Therapeutic Uses :

Prameha Arsha Grahani Krimi

Kushtha Gulma Udar Roga Twakvikar

Kandu pleeha vatarakta raktapita

Dosage 133

Decoction (Bark) - 50-100ml

Leaf juice - 10-20 ml

Flower powder - 3-6 gm

Kshara Kalpana

Kshara means strong caustic. Acharya Sushruta and Vagbhata have dedicated one whole

chapter in sutrasthana for kshara preparation and kshara karma. Acharya Charaka has

mentioned 18 plants of which kshara can be prepared.

Kshara is of two types depending upon its mod of administration.134,135

Paniya (oral adminstration)

Pratisarniya (local application)

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Pratisarniya can be further divided into the following depending upon its strength.136,137

Mrudu Madhyama Tikshana

Definition of kshara

Acharya Sushruta defines the kshara; the substance possessing Ksharana and Kshanan

properties.138

Explanation of these two words by Dalhana is as under.

Ksharana means one which mobilises and removes the deformed skin,flesh etc. or

which removes the vitiated Doshas.139

Although as Dalhana mentioned a few authorities

considered the refrence. As ksharana means shodhana (purification).

Although as Dalhana mentioned a few authorities considered the reference. As ksharan

means as Ksharan means Shodhan [ purification ]. Probably these two groups

of authorities intended to narrate the meanings of Ksharana and Kshapana as about.

Kshanan means which destructs the deformed Skin, Flesh etc.140

Acharya Charaka defines kshara as one which scraps the abnormal tissue from

the locating viscera and drags it down after dissolving because of its corrosive nature141

.

Properties of Kshara142

:

Rasa : Katu

Veerya : Ushna

Guna : Tikshna, Agnaja, Slakshna

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Vrana : Krish

Doshagnata: Trisdoshghnta

Karma : Dahana, Pachana, Darana, Vilayan, Shodhana, Ropana

Table no 18- Desirable qualities of kshara:143,144

Acharya Sushrutaand Vagbhatta have mentioned the properties of a prepared.

S.No Qualities Sushruta Vagbhatta

1 Nati Tikshna + +

2 Nati Mridu + +

3 Nati Shukla + +

4 Slakshanata + +

5 Pichhila + +

6 Avishyanda + +

7 Shighrakarita + +

8 Shiva + +

9 Shikhari + -

10 Sukha Nirvapya + +

11 Alpa Rakta + +

Tableno. 19-Undesirable qualities of kshara :145,146

For the prepared kshara the few qualities are mentioned that are undesirable and may

appear either due to faulty process or unwholesome knowledge of the Vaidya.

S.No Qualities Sushruta Vagbhatta

1 Atimrudu + +

2 Atiushna + +

3 Atishweta + +

4 Atitikshana + +

5 Atipichhila + +

6 Ativisarpta + +

7 Atisandrata + +

8 Apaka vata + +

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9 Hin dravta + +

10 Ati tanu - +

Method of preparation:147,148,149,150

The plant , from which the kshara is to be prepared, is dried completely and cut into small

pieces . these pieces of plant are to be burnt to ash. To this ash 6 parts of water (4 parts of

water according to yoga ratnakar, sharangdhara, rasatrangini) should be added, stirred well

and kept over night . Next morning it should be added, stirred well and kept overnight . next

morning, it should be filtered through a thick cloth . the process of washing should be done

repeated 21 times with the different samples of water. Now the residue (ash) will be filtered.

All the filtrates should be taken in the stainless steel vessel and heated to evaporate all the

watery content . the Kshara, thus collected in the form of flakes, at the bottom of the vessel

is powdered and preserved in the glass bottle.

ARKA

INTRODUCTION:151

In Rasashastra Arka has been described in the visha group.It is a shrub which grows wild in

the countryside all over India.

Varities:152

Calotropis gigantean(purple flower)

Calotropis procera(white flower)

Vernacular names153,154

Sanskrit : Arka

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English : Swallow Wort

Hindi: Madar

Latin name : Calotropis giganeta

Synonyms:155

Swetarka alarka

Mandara Swetapuspa

Gana:156

Bhedaniya vamanopaga Swedopaga(Charka)

Adhobhagahara Arkadi(Sushruta)

Chemical Composition:157

Leaves- Alkaloids latex - trypsin , calotropin

Stem and roots – emylyn and gigantial.

Shodhana158

As the latex of arka are naturally purified, there is no need of purification.

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Pharmacological properties.159,160

Table no20. –Pharmacological properties of arka

Rasa Katu , titkta

Guna Laghu, ruksha,tikshna

Virya Usna

Vipaka Katu

Pharmacological actions:161

Vatahara dipena rechana

vishahara vrushya (flower)

Indications162

:

Kushta kandu purishaja krimi udaraplihavridhi

Arsha shwasa kasa shotha.

Part used163

:

Mulatwaka Ksira

pushpa patra

Dose164

:

Mulatwaka churna - ½ gms – 1 gms.

Pushpa churna- 1-3 gms.

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Ksira- 1/2gms- 1gms.

Therapeutic uses.

Pama, vicharchika, swasa, plihavriddhi, krimidanta, nukhaksata, arsha, mukha krsnatwa,

kasa.

Untoward effect165

Excessive intake of arkakshira causes vomiting and diarrohoea, polyurea and burning

sensation in the tounge.

Treatment of untoward effect. 166

Sugar mixed in the cold water is given for the management.

CHURNODAKA 167

In the present study the Churnodaka was used in the Shodhana of Hartala.

Method of preparation

Two Ratti (250 mg) of Churnaka is added to five tola (60 ml) of purified water and

left it for about 3 Yamas (9 hours). Then filtered with the help of filter paper and preserved

in dark coloured glass bottle. The filtered water, which prepared is called as Churnodaka or

Shudhodaka.

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Gunas

It cures diarrhoea. External and internal applications are used for the treatment of

Krimiroga. It reduces acidity. It is also useful in breast-feeding child. It destroys

abdominal pain and Grahini roga. It reduces the toxic reactions of Sulphuric acid.

Matra

Pediatric dose : 30-60 drops Adult dose : 2 tolas.

Calcii Hydroxidum 168

(Calc. Hydrox CaCOH) 2

Source : Freshly prepared by the action of water on lime.

Characters : Soft, white alkaline, slightly bitter.

Solubility : Slightly soluble in water.

Incompatibles : Minerals, Acids and Metallic Salts.

Pharmacology & Therapeutics

Externally- caustic , astringent, sedative.

Internally- antacid, antidote for poisoning by the mineral acids, oxalic acid, zinc chloride.

Methodology

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PHARMACEUTICAL STUDY

Pharmaceutical study means the practical experience of preparing medicines from

raw drugs. Practical experience is most essential for Vaidya as described by Charaka ‘The

Karmabhyasa’ (Cha. Su. 9/22) is one of the essential qualities of Vaidya. In Rasa Shastra it

is described that Rasa Shastrajna must have the quality of ‘Kushala Rasa Karmani’ (R.R.S.

6/4).

Rasa Shastra is a science which mainly deals with minerals and metals and their

administration as medicines. These minerals cause some toxic and untoward effects if they

are not properly processed or prepared by proper method and difference in procedure of

preparation may have variation in the properties and may produce harmful effects in

patients.

Hence, preparation of mineral drugs requires more skill and the only way of

obtaining skill is practical experience through repeated practicals and careful observations

during the process. Thus, makes Rasa Vaidya perfect in medicinal preparation.

By this it is very clear that theory and practical are two essential parts of the

knowledge. Only theoretical knowledge can not make a man perfect. Physician fights

against the diseases with the weapon named medicine.

Acharya Sushruta has mentioned that the knowledge of Yogya or Pratyaksha Karmabhyasa

is must for a surgeon. In the same way, preparation of medicine requires a great attention as

the life of the human being is precious.

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The practical aspect of Rasa and related substances is having much more importance

in comparison to their theoretical aspects in Rasa Shastra. Validity of this branch of science

totally depends on the successful pharmaceutical process. A pharmaceutical process called

Kalpana by alchemist forms the basic principle of Rasa Shastra which has got its own place

and importance in it.

Study design –

This section includes major steps –

Step 01. : Identification and Collection of raw drugs.

Step 02. : Purification and processing of raw drugs.

Step 03. : Preparation of romashatana lepa.

Date of commencement : 08/02/2012

Date of completion : 12/04/2012

Reference : Sharangdhara Samhita Uttar Khand, 11/ 38- 39

Method

Step 01. : Identification and collection of raw drugs.

Date of commencement : 08/02/2012

Date of completion : 15/02/2012

Proper identification, selection and collection of raw drugs are necessary for

Ayurvedic formulations, because without these things we cannot assure the quality

Methodology

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of our medicaments. So this section of the study deals with the same. contains

romashatana lepa the following ingredients –

Ingredients –

1 Hartala --- 1 part

2 Shankha churna --- 3 parts

3 Palasha kshara --- 1 part

4 Arka patra swarasa – q.s

Special request was made to the local herbo-mineral drug shop dealer to get

the particular quality drugs and those were screened for classical grahya lakshanas

and those were certified by the concerned departments.

Step 02. : Purification and processing of raw drugs.

Ayurveda has enlisted certain drugs, which will cause adverse effects or no

therapeutic effects if used in the impure state or may lead to complication. So proper

purification is necessary to combat the probable adverse effects. This section deals

with the purification and processing of raw drugs.

Practical no. 01

Title : Shankha churnikarna

Reference : Sharangdhara Samhita madhyam Khand, .6/1

Materials required : Khalwa yantra., Spoon, Steel plates, sieve no. 120, steel vessel

Methodology

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Ingredients - shankha

Method of Preparation:

Prakshalana(washing with hot water ) of shankh was done before subjecting it to

churnikarna. Particular quantity was weighed and taken in Khalwa yantra & by pounding it

was made into churna and sieved through sieve no. 120, the procedure was repeated until

complete fine powder was obtained and stored in clean air tight bottle. This procedure was

repeated for 3 times and the details of the quanitiy are discussed in the table.

Observation:-

1 A smooth white coloured powder (churna) is obtained.

2 Taste- alkaline

Precaution:-

1 Khalwa yantra was clean and dry before carrying out the procedure.

2..Pounding should be done in such a manner that there should be minimum loss

of the churna.

3. A well washed and cleaned vessel should be used.

4. During sieving the precaution should be taken to avoid the loss.

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Table No.21 . Results of process of : Shankha churnikarna

S.No Particulars Quantity

I II III

1. Initial Quantity of shankha 370gms 348gms 386gms

2. Obtained Final product 348gms 355gms 363gms

3. Loss of shankha 22gms 24gms 23gms

4. Date of Start 17/2/2012 21/2/2012 25/2/2012

5. Date of completion 19/2/2012 24/2/2012 28/2/2012

Practical No 02

Title : Hartala shodhana

Reference: RRS 3/70

Materials : Ashodhita hartala , Choornodaka

Method : Swedana

Equipment: Dolayantra ,Khalwa yantra., Spoon, Steel plates, sieve no. 120, steel

vessel

Note:- Churnodaka preparation. As the Churnodaka is required as the liquid media

in dola yantra for the shodhana of hartala .

Refrence- R.T11/216

Method of preparation

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45gms of Churnaka is added to 9 litre of purified water and left it for about 3

Yamas (9 hours). Then filtered with the help of filter paper and preserved in dark

coloured glass bottle. The filtered water, which prepared is called as Churnodaka or

Shudhodaka.

Hartala shodhana:-

Procedure:

Ashodhita Hartala pieces are kept in cotton cloth and made into pottali.

Potalli is suspended in Dolayantra containing churnodaka.Swedana is done for one

yama in Mandagni. The hartala was dried and by pounding in Khalwa yantra it was

made into churna and sieved through sieve no. 120..This procedure is repeated for 3

times.

Observations

1.Colour of Hartala will not change.

2.Colour of Churnodaka becomes yellowish and thick

Precautions

1.Pottali does not touches the bottom of pot.

2. Mandagni should be maintained.

3.After swedana Haratala should be washed with hot water.

4. Khalwa yantra was clean and dry before carrying out the procedure.

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5. Pounding should be done in such a manner that there should be minimum loss of the

churna.

6. A well washed and cleaned vessel should be used.

7. During sieving the precaution should be taken to avoid the loss.

Table No. 22- Results of process of Hartala shodhana

S.No Particulars Quantity

I II III

1. Initial Quantity of hartala 240gms 233gms 215gms

2. Obtained Final product 209gms 206gms 186gms

3 Quantity of Churnodaka used 7 lt 6.4 lt 6 lt

4 Loss of hartala 31gms 27gms 29gms

5. Date of Start 01/03/2012 06/03/2012 11/03/2012

6. Date of completion 05/03/2012 09/03/2012 16/03/2012

Practical No 03

Title : preparation of palasha kshara

Reference: Sharangdhara Samhita madhyam Khand, .11,Y.R, R.T

Equipment: stove , cloth , steel spoon, steel vessels,

Ingredient : palasha stems

Plasha stems ash- 1 part.

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Water – 6 part

Method of preparation.

The Palasha stem was taken and dried completely and cut in to small pieces. These pieces

were burnt to ash. To these ash 6 parts of water was added, stirred well and kept for an

overnight. Next morning it was macerated well and filtered through a three folded cloth.

The washing process was repeated for 21 times .All the filtrate was taken in a stainless steel

vessel and heated to evaporate all the watery portion on mandagni with intermittent stirring.

The Kshara thus collected in the form of flakes at the bottom of vessel and it was powdered

and preserved in an air tight glass bottle. This procedure was repeated for 3 times and the

details of the quanitiy are discussed in the table

Observation:-

1 Flakes of kshara is obtained which is pounded and grayish coloured powder (churna)

is obtained.

2 Taste- alkaline

Precaution:-

1. The stem should be completely dried prior to burn.

2. Stem should be completely converted into ash.

3. Precaution should be taken so that the ash would not blow away with the wind.

4. Proper weighing of the ash should be done.

5. The cloth should for filteration should be clean and three folded.

6. Careful filteration should be done to avoid the loss of the filterate.

Methodology

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7. Madhyamagni was maintained until completion of process of kshara preparation

from the filterate.

8. Only stainless steel should be used.

Table No.23- Results of process of palasha kshara

S.No Particulars Quantity

I II III

1. Initial Quantity of palasha stems 25kg 19kg 15kg

2. Ash obtained 2.8kg 2.5kg 2.3kg

3 Water 16.8 lt 15 lt 13.8lt

4 Obtained final product 110 gms 108 gms 102gms

5 Time taken for the dehydration of

filterate

5.40hrs 5.30hrs 5.20 hrs

6 Temp. maintained during dehydration

of filterate

120oc 120

oc 120

oc

7. Date of Start 18/03/2012 26/03/2012 03/04/2012

8. Date of completion 2403/2012 01/04/2012 08/04/2012

Practical No 04

Title : preparation of romashatana lepa

Equipment: Khalva yantra, steel spoon

Ingredient : shankh churna- 3part .

hartala churna- 1 part.

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palasha kshara – 1 part.

Method of preparation.

The ingredients were taken in the specific quantity in the Khalva yantra one after

another and then through mixing of all the ingredients was done so that they get

homogenously mixed & after that it was preserved in an air tight glass bottle.

Observation

1 A buff coloured powder is obtained.

2 taste- alkaline.

Precautions

1 Proper mixing should be done so that it should be homogenous mixture.

2 Preservation should be done in air tight glass bottle.

3 While mixing care should be taken to avoid the loss of the lepa churna.

Methodology

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Table No.24-. Results of preparation of romashatna lepa.

S.No Particulars Quantity

I II III

1. Initial Quantity of shankh churna 330gms 324gms 306gms

2. Initial Quantity of hartala churna 110 gms 108gms 108gms

3. Initial Quantity of palasha kshara 110gms 108gms 102gms

4. Obtained final product 550gms 540gms 510gms

5. Date of Start 09/04/2012 10/04/2012 12/04/2012

6. Date of completion 09/04/2012 10/04/2012 12/04/2012

The prepared romashatana lepa was stored in a sterile, Sun protected glass

container. The best sample among 3 samples of romashatana lepa was used in

Analytical and clinical studies.

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ANALYTICAL STUDY169

The Rasoushadhies mentioned in Ayurvedic Pharmacopoeia should be analyzed for

physical and chemical properties to confirm the genuinity and safety before administration

to the patients. Hence it is essential to adopt modern analytical methodology for better

understanding and interpretation of physico-chemical changes occurred during the process.

In the present study, romashatana lepa prepared according to classical method is

collected and subjected to modern analytical methods at BANGLORE TEST HOUSE D-

36, 4TH

MAIN, KSSIDC INDUSTRIAL ESTATE, RAJAJI NAGAR, BANGLORE.

Analysis of romashatana lepa

1) Organoleptic characters

Colour : buff coloured

2) Determination of pH –

Procedure: The pH value of the sample was determined by a Digital pH meter.

One gram of romashatana lepa was weighed accurately and dissolved in 100ml of water

and pH was noted in the Digital pH meter.

Result: pH value: 8.78

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3) Loss on drying at 1100C

1100C till a constant weight is obtained. The difference in weight was calculated and

the result is attached 2gms of romashatana lepa weighed accurately in a silica crucible and

dried in a hot air oven at.

Result: 1.25% w/w

4) Loss on Ignition:

Procedure:

Weigh a silica crucible previously ignited for one hour at a temperature not exceeding

500°C and cooled in desiccators. Transfer to the crucible accurately weighed sample.

Weigh the crucible accurately. Place the loaded crucible in the muffle furnace &ignite the

crucible to 500°C, until constant weight is indicated. Calculate loss on ignition with

reference to the air dried drug.

Result: 18.85% w/w

5) Determination of Total Ash

Take about 2gm accurately weighed, ground drug in a previously tared silica dish,

previously ignited and weighed. Scatter the ground dry in a fine even layer on the bottom of

the dish. Incinerate by gradually increasing the heat not exceeding dull red heat (4500C)

until free from carbon, cool and weigh. Calculate the percentage of ash with reference to the

air-dried drug.

Result: 81.15% w/w

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6) Acid Insoluble Ash

Boil the ash obtained in the process described under determination of total ash for 5

minutes with 25ml of dilute hydrochloric acid. Collect the insoluble matter on an ash less

filter paper wash with hot water and ignite. Weigh it and calculate the percentage of acid

insoluble ash with reference to the air dried drug.

Result: 8.89% w/w

7) Determination of Fineness of particles :

Procedure :

The degree of coarseness or fineness of a powder is differentiated and expressed by

the size of the mesh of the sieve through which the particle is able to pass.A suitable

quantity of the sample is weighed and transferred to the set of sieves shaken in a sieve

shaken for about 30minutes and the residue on each sieve is weighed separately.

Results: Fineness of particles 84.43% of sample particle passes through sieve no. 120

8) SOLUBILITY TEST

About one gram of the sample was weighed and dissolved in 10ml of the solvents. It was

found that the romashatana lepa is 5.52% soluble in water and 16.72% soluble in alcohol

Result: water solubility : 5.52%, alcohol soluble: 16.72%

9) Estimation of Arsenic:

Arsenious salts: neutral solutions react with silver nitrate to form yellow precipitate

of silver arsenite – soluble in ammonia solution and in nitric acid.

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Arsenious salts in neutral solutions react with solution of copper sulphate to form

green precipitate which on boiling gives a red precipitate of cuprous oxide.

Result: 2.31% w/w

10) Estimation of Calcium

Procedure: Weigh accurately oppropriate quantity of the sample and dissolve in 3ml of

dilute hydrochloric acid and 10 ml of water. Boil for 10 minutes. Cool, dilute to 50ml with

water. Titrate width 0.05M Disodium edetate to within a few ml of the expected end point,

add 8ml of Sodium Hydroxide solution (saturated solution) and 0.1g of the calcon mixture

and continue the titration until the colour of the solution changes from pink to full blue

colour. Each ml of 0.05 M Disodium edetate is equivalent to 0.0020 g of calcium.

Result: 22.0% w/w .

Methodology

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Table no25. Showing the analytical report

S.no Test Results

01 Determination of pH

8.78

02 Loss on drying at 1100C 1.25% w/w

03 Loss on Ignition: 18.85% w/w

04 Determination of Total Ash 81.15% w/w

05 Acid Insoluble Ash 8.89% w/w

06 Determination of Fineness of particles

:

84.43% of sample particle passes

through sieve no. 120

07 Solubility Test water solubility : 5.52%, alcohol

soluble: 16.72%

08 Estimation of Arsenic:

2.31% w/w

09 Estimation of calcium:

22.0% w/w .

All the parameters are well within the normal range as per the protocol by the API Part ll.

Methodology

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CLINICAL STUDY

The present clinical study was meant for clinical efficacy of romashatana lepa w.s.r.

to its depilation activity in foot hair. Total 30 volunteers were included. All the volunteers

were assessed before treatment and on follow up . According to the criteria of assessment as

mentioned in the Performa of the case sheet.

The Clinical study consists of following headings –

I. Selection of patients.

II. Research Design.

III. Duration and Method of administration of drug.

IV. Parameters of Assessment.

V. Criteria for Assessment of Results

I. Selection Of Patients :

The 30 volunteers who had hair in the foot region were selected after critical

adaptation of inclusion and exclusion criteria.

a) Source of data :

30 volunteers were taken from OPD of DGM Ayurvedic Medical College

Hospital, Gadag.

The Samples were selected by simple sampling technique.

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b)Inclusion criteria :

Age- Volunteers having hair over foot region from 15-45 age groups are

taken for study.

Apparently healthy volunteers are taken

Sex- Volunteers of either sex are included.

c) Exclusion criteria:

Volunteers suffered with fever for more than 15 days, past two months will

be excluded.

Volunteers taking medicine like Allopurinol, choloroquinine will be

excluded.

Volunteers who are suffering from allergic skin manifestations like

dermatitis, eczema, and other skin diseases will be excluded.

Volunteers who are taking one of the ingredients as Haratala, Shankha,

Palasha kshara in medicine formulations for any diseases will be excluded.

d) Intervention:

The volunteers are assessed before treatment and on follow up as per

assessment criteria.

The 13 volunteers are male and 17 volunteers are female.

Preparation of the part.

The 3 sq.cm area on the dorasal surface is shaved in the foot region in

males.

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Threading was done in 3 sq.cm area on the dorasal surface in the foot region

in females.

Application of the lepa.

30 gram of powder (ingredient of romashatana lepa) is taken and mixed

with 10 ml of arka patra swarasa to have a uniform paste. This uniform

paste is applied on the 3 sq. cm area as per the requirement so as to get the

uniform thickness.

It is applied opposite to the direction of the roma.

Removal of the lepa

Just before complete drying it is removed

II Research Design:

The study was conducted on total 30 volunteers who could continue the treatment

for full duration and come for follow up till to the last, the patient was selected from the

OPD, DGM Ayurvedic Medical College & Hospital for prospective clinical trial.

III Duration And Method Of Administration Of Drug :

Study duration - 7days. Follow up - 7 days.

Method of Administration: Local application of romashatana lepa

Dosage – As required

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IV Parameters For Assessment:

Subjective parameters:

Table No. 26 Showing the gradation which is adopted in statistical evaluation

Number of Hair in 3 sq. cm area Grades

0 0

1-5 1

6-10 2

11-15 3

16-20 4

21 & >21 5

Table No. 27. Showing the gradation, which is adopted, in statistical evaluation of

Growth of Hair in 3 sq. cm area in mm Grades

0 0

1-2 1

3-4 2

5-6 3

7-8 4

9& >9 5

Methodology

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 83

Assessment of Result:

Assessment of results will be done based on the gradings and before treatment & on follow

up by carrying paired ‘t’ test .

V Criteria For Assessment Of Results:

a) Number of Hair in 3 sq. cm area

Complete result - 100% , grade 0 with no associated complaint on follow up.

Marked result - 75%, grade 1-2 with no associated complaint on follow up.

Moderate result - 50%, grade 3-4 with min. associated complaint on follow up.

Mild result - 25%, grade 5 with associated complaint on follow up.

No result - < 25% no changes seen

b) Growth of Hair in 3 sq. cm area in mm

Complete result - 100% , grade 0 with no associated complaint on follow up.

Marked result - 75%, grade 1-2 with no associated complaint on follow up.

Moderate result - 50%, grade 3-4 with min. associated complaint on follow up.

Mild result - 25%, grade 5 with associated complaint on follow up.

No result - < 25% no changes seen.

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 84

RESULTS

DEMOGRAPHIC DATA

Distribution of volunteers by Age –

Table No.28 . Showing the distribution of volunteers by age groups.

Sl. Age group No. of volunteers. Percentage

01. 16-25 20 66.66

02. 26-35 9 30.00

03. 36-45 1 03.33

It was observed that, the maximum number of volunteers 20 (66.66%) were in the age group

of 15-25; 9 (30%) from the age group of 25-35 years and only 1 (03.33%) in the age group

(36-45)

Graph no. 01- Distribution of volunteers by age group

0

5

10

15

20

1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

16-25

26-35

36-45

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 85

Distribution of volunteers by Sex –

Table No.29 . Showing the distribution of volunteers by Sex –

Sl. Sex No. of volunteers. Percentage

01. Male 13 43.33

02. Female 17 56.66

It was observed that, out of 30 volunteers maximum number of volunteers i.e. 17 (56%)

were females and males were 13 (43%).

Graph No. 02. Graph showing the sex incidence of the volunteers .

0

2

4

6

8

10

12

14

16

18

male no. of volunteers

female no. of volunteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 86

Data related to response to the treatment

Number of Hair in 3 sq. cm area

Table No.30. Showing the response of the therapy before and after the treatment.

Sl. Grading B.T. % A.T. %

No. of volunteers. No. of volunteers.

01. 0 0 0 18 60.00

02. 1 11 36.66 7 23.33

03. 2 14 46.67 5 16.67

04. 3 5 16.67 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 30 volunteers, 11(36.66%) volunteers had the grade 1 ,14 (46.67%)

volunteers had the grade 2 and 5 (16.67%) volunteers are in grade 3 before the treatment.

No volunteers belong to 0 ,4nd 5 grade. After the treatment 18 (60%) volunteers had 0 grade

and 7 (23.33%) volunteers had the 1 grade & 5 (16.67%) volunteers had the 2 grade.

No volunteers had grade 3,4 and 5. Statistically it is highly significant, where p value is

<0.001.

Graph No.03- Showing response before and after the treatment.(for no.of hair)

0

5

10

15

20

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

A.T No. of Voluntrees

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 87

Number of Hair in 3 sq. cm area

Table No.31 . Showing the response of the therapy before and on follow up.

Sl. Grading B.T. % F.U %

No. of volunteers. No. of volunteers.

01. 0 0 0 18 60.00

02. 1 11 36.66 7 23.33

03. 2 14 46.67 5 16.67

04. 3 5 16.67 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 30 volunteers, 11(36.66%) volunteers had the grade 1, 14 (46.67%)

volunteers had the grade 2 and 5 (16.67%) volunteers are in grade 3 before the treatment.

No volunteers belong to 0 ,4nd 5 grade. On follow up18 (60%) volunteers had 0 grade and 7

(23.33%) volunteers had the 1 grade & 5 (16.67%) volunteers had the 2 grade. No

volunteers had grade 3,4 and 5. Statistically it is highly significant, where p value is <0.001.

Graph no.04 - Showing response before the treatment and on follow up .(for no.of hair).

0

5

10

15

20

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

F.U No. of volunteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 88

Number of Hair in 3 sq. cm area in males.

Table No.32. Showing the response of the therapy before and after the treatment.

Sl. Grading B.T. % A.T. %

No. of volunteers. No. of volunteers.

01. 0 0 0 1 7.69

02. 1 2 15.38 7 53.48

03. 2 6 46.15 5 38.46

04. 3 5 38.46 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 13 volunteers, 2 (15.38%) volunteers had the grade 1, 6 (46.15%)

volunteers had the grade 2 and 5 (38.36%) volunteers are in grade 3 before the treatment.

No volunteers belong to 0, 4 and 5 grade. After the treatment 1 (7.69%) volunteers had 0

grade and 7 (53.48%) volunteers had the 1 grade & 5 (38.46%) volunteers had the 2 grade.

No volunteers had grade 3,4 and 5. Statistically it is highly significant, where p value is

<0.001.

Graph No.05 Showing response before and after the treatment in males .(for no.of

hair)

0

1

2

3

4

5

6

7

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

A.T No. of Voluntrees

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 89

Number of Hair in 3 sq. cm area in males.

Table No.33. Showing the response of the therapy before and on follow up

Sl. Grading B.T. % F.U %

No. of volunteers. No. of volunteers.

01. 0 0 0 1 7.69

02. 1 2 15.38 7 53.48

03. 2 6 46.15 5 38.46

04. 3 5 38.46 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 13 volunteers, 2 (15.38%) volunteers had the grade 1, 6 (46.15%)

volunteers had the grade 2 and 5 (38.36%) volunteers are in grade 3 before the treatment.

No volunteers belong to 0 ,4nd 5 grade. On follow up 1 (7.69%) volunteers had 0 grade and

7 (53.48%) volunteers had the 1 grade & 5 (38.46%) volunteers had the 2 grade. No

volunteers had grade 3,4 and 5. Statistically it is highly significant, where p value is <0.001.

Graph no.06 - Showing response before the treatment and on follow up in males .(for no.of

hair)

0

1

2

3

4

5

6

7

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

F.U No. of volunteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 90

Number of Hair in 3 sq. cm area in females.

Table No.34. Showing the response of the therapy before and after the treatment.

Sl. Grading B.T. % A.T. %

No. of volunteers. No. of volunteers.

01. 0 0 0 17 100

02. 1 9 52.94 0 0

03. 2 8 47.05 0 0

04. 3 0 0 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 17 volunteers, 9 (52.94) volunteers had the grade 1, 8(47.05%)

volunteers had the grade 2 before the treatment. No volunteers belong to 0, 4 and 5 grade.

After the treatment 17 (100%) volunteers had 0 grade No volunteers had grade 1,2 3,4 and

5. Statistically it is highly significant, where p value is <0.001.

Graph No.07 Showing response before and after the treatment in females .(for no.of hair)

0

5

10

15

20

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

A.T No. of Voluntrees

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 91

Number of Hair in 3 sq. cm area in females.

Table No.35. Showing the response of the therapy before and on follow up.

Sl. Grading B.T. % F.U. %

No. of volunteers. No. of volunteers.

01. 0 0 0 17 100

02. 1 9 52.94 0 0

03. 2 8 47.05 0 0

04. 3 0 0 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 17 volunteers, 9 (52.94) volunteers had the grade 1, 8(47.05%)

volunteers had the grade 2 before the treatment. No volunteers belong to 0,3, 4 and 5 grade.

On follow up 17 (100%) volunteers had 0 grade No volunteers had grade 1,2 3,4 and 5.

Statistically it is highly significant, where p value is <0.001.

Graph no.08 - Showing response before and after the treatment in females. .(for no.of hair)

0

5

10

15

20

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

F.U No. of volunteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 92

Growth of Hair in 3 sq. cm area in mm

Table No.36. Showing the response of the therapy before and after the treatment.

Sl. Grading B.T. % A.T. %

No. of volunteers. No. of volunteers.

01. 0 0 0 30 100

02. 1 4 13.33 0 0

03. 2 22 73.33 0 0

04. 3 4 13.33 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 30 volunteers, 4(13.33%) volunteers had the grade 1 ,22 (73.33%) volunteers

had the grade 2 and 4(13.33%) volunteers are in grade 3 before the treatment. No

volunteers belong to 0 ,4nd 5 grade. After the treatment 30(100%) volunteers had 0 grade.

No volunteers had grade 1,2,3,4 and 5. Statistically it is highly significant, where p value is

<0.001.

Graph No.09 Showing response before and after the treatment (for growth of hair )

0

5

10

15

20

25

30

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

A.T No. of Voluntrees

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 93

Growth of Hair in 3 sq. cm area in mm

Table No.37. Showing the response of the therapy before and on follow up.

Sl. Grading B.T. % F.U. %

No. of volunteers. No. of volunteers.

01. 0 0 0 28 93.33

02. 1 4 13.33 2 6.67

03. 2 22 73.33 0 0

04. 3 4 13.33 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 30 volunteers, 4(13.33%) volunteers had the grade 1 ,22 (73.33%)

volunteers had the grade 2 and 4(13.33%) volunteers are in grade 3 before the treatment.

No volunteers belong to 0 ,4nd 5 grade. On follow up 30(100%) volunteers had 0 grade. No

volunteers had grade 1,2,3,4 and 5. Statistically it is highly significant, where p value is

<0.001.

Graph no. 10- showing the response before the treatment and on follow up (for growth of

hair)

0

5

10

15

20

25

30

grade 0 grade 1 grade 3 grade 4 grade 5

B.T No. of volunteers

F.U No. of volunteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 94

Growth of Hair in 3 sq. cm area in mm in males.

Table No.38. Showing the response of the therapy before and after the treatment.

Sl. Grading B.T. % A.T. %

No. of volunteers. No. of volunteers.

01. 0 0 0 13 100

02. 1 1 7.69 0 0

03. 2 8 61.53 0 0

04. 3 4 30.76 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 13 volunteers, 1 (7.69%) volunteers had the grade 1, 8(61.53%)

volunteers had the grade 2 and the 4 (30.76%) volunteers has grade 3 before the treatment.

No volunteers belong to 0, 4 and 5 grade. After the treatment 13 (100%) volunteers had 0

grade No volunteers had grade 1,2 3,4 and 5. Statistically it is highly significant, where p

value is <0.001.

Graph no.11- showing response before and after the treatment in males(for growth of hair )

0

2

4

6

8

10

12

14

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

A.T No. of Voluntrees

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 95

Growth of Hair in 3 sq. cm area in mm in males.

Table No.39. Showing the response of the therapy before and on follow up.

Among the 13 volunteers, 1 (7.69%) volunteers had the grade 1, 8(61.53%) volunteers had

the grade 2 and the 4 (30.76%) volunteers has grade 3 before the treatment. No volunteers

belong to 0, 4 and 5 grade. On follow up13 (100%) volunteers had 0 grade No volunteers

had grade 1,2 3,4 and 5. Statistically it is highly significant, where p value is <0.001.

Graph no.12- showing response before the treatment and on follow up in males (for growth

of hair )

0

2

4

6

8

10

12

grade 0

grade 1

grade 2

grade 3

grade 4

grade 5

B.T No. of volunteers

F.U No. of volunteers

Sl. Grading B.T. % F.U. %

No. of volunteers. No. of volunteers.

01. 0 0 0 11 84.61

02. 1 1 7.69 2 15.38

03. 2 8 61.53 0 0

04. 3 4 30.76 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 96

Growth of Hair in 3 sq. cm area in mm in females.

Table No.40. Showing the response of the therapy before and after the treatment.

Sl. Grading B.T. % A.T. %

No. of volunteers. No. of volunteers.

01. 0 0 0 17 100

02. 1 3 17.60 0 0

03. 2 14 82.35 0 0

04. 3 0 0 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Among the 17 volunteers, 3 (17.6%) volunteers had the grade 1, 14 (82.35%)

volunteers had the grade 2 and before the treatment. No volunteers belong to 0,3, 4 and 5

grade. After the treatment 17 (100%) volunteers had 0 grade No volunteers had grade 1,2

3,4 and 5. Statistically it is highly significant, where p value is <0.001.

Graph No. 13. Showing response before and after the treatment in females (for growth of

hair )

0

5

10

15

20

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

A.T No. of Voluntrees

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 97

Growth of Hair in 3 sq. cm area in mm in females.

Table No.41. Showing the response of the therapy before and on follow up.

Among the 17 volunteers, 3 (17.6%) volunteers had the grade 1, 14 (82.35%) volunteers had

the grade 2 and before the treatment. No volunteers belong to 0,3, 4 and 5 grade. On follow

up 17 (100%) volunteers had 0 grade No volunteers had grade 1,2 3,4 and 5. Statistically it

is highly significant, where p value is <0.001

Graph no.14 - Showing response before the treatment and on follow up in females (for

growth of hair ).

0

5

10

15

20

grade 0 grade 1 grade 2 grade 3 grade 4 grade 5

B.T No. of volunteers

F.U No. of volunteers

Sl. Grading B.T. % F.U. %

No. of volunteers. No. of volunteers.

01. 0 0 0 17 100

02. 1 3 17.60 0 0

03. 2 14 82.35 0 0

04. 3 0 0 0 0

05. 4 0 0 0 0

06. 5 0 0 0 0

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 98

OVERALL RESULT

Overall result assessed on the basis of the gradings before the treatment and on follow up.

Table no 42- Overall result for number of Hair in 3 sq. cm area

Sl. Overall result No. of

volunteers.

Percentage

01. Complete (CR) 17 56.66

02. Marked (MaR) 13 43.33

03. Moderate (MoR) 0 0

04. Mild (MiR) 0 0

05. No (NR) 0 0

Among the 30 cases

17 volunteers (i.e. 56.66%) had shown complete result.

13 volunteers (i.e. 43.33%) had shown marked result.

Graph no. 15 – Showing overall result for number of hair in 3 sq. cm area.

0

5

10

15

20

CR MaR MoR MiR NR

no. of vounteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 99

Table no. 43- Overall result of Growth of Hair in 3 sq. cm area

Sl. Overall result No. of volunteers.. Percentage

01. Complete (CR) 28 93.33

02. Marked (MaR) 2 6.67

03. Moderate (MoR) 0 0

04. Mild (MiR) 0 0

05. No (NR) 0 0

Among the 30 cases

28 volunteers (i.e. 93.33%) had shown complete result.

2 volunteers (i.e. 6.67%) had shown Marked result .

Graph no.16 - showing overall result for growth of hair in 3 sq. cm

Table no 44- overall result for number of Hair in 3 sq. cm area in males

Sl. Overall result No. of volunteers. Percentage

01. Complete result (CR) 0 0

02. Marked result (MaR) 13 100

03. Moderate result (MoR) 0 0

04. Mild result (MiR) 0 0

05. No result (NR) 0 0

0

5

10

15

20

25

30

CR MaR MoR MiR NR

no. of vounteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 100

Among the 13 cases

13volunteers (i.e. 100%) had shown Marked result.

Graph no.17 – Showing overall result for number of hair in 3 sq. cm area in males

Table no- 45 overall result for number of Hair in 3 sq. cm area in females

Sl. Overall result No. of volunteers. Percentage

01. Complete (CR) 17 100

02. Marked (MaR) 0 0

03. Moderate (MoR) 0 0

04. Mild (MiR) 0 0

05. No (NR) 0 0

Among the 17 cases

17 volunteers (i.e. 100%) had shown Complete result.

Graph no. 18– Showing overall result for number of hair in 3 sq. cm area in females.

0

5

10

15

CR MaR MoR MiR NR

no. of vounteers

0

5

10

15

20

CR MaR MoR MiR NR

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 101

Table no. 46- Overall result for growth of Hair in 3 sq. cm area in males

Sl. Overall result No. of volunteers. Percentage

01. Complete (CR) 11 84.61

02. Marked(MaR) 2 15.38

03. Moderate (MoR) 0 0

04. Mild (MiR) 0 0

05. No (NR) 0 0

Among the 13 cases

11 volunteers (i.e. 84.61%) had shown complete result.

2 volunteers (i.e. 15.38%) had shown marked result.

Graph no.19 - Showing overall result for growth of hair in 3 sq. cm in males.

Table no. 47 overall result for growth of Hair in 3 sq. cm area in females.

Sl. Overall result No. of volunteers. Percentage

01. Complete (CR) 17 100

02. Marked (MaR) 0 0

03. Moderate(MoR) 0 0

04. Mild (MiR) 0 0

05. No (NR) 0 0

0

5

10

15

CR MaR MoR MiR NR

no. of vounteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 102

Among the 17 cases

17 volunteers (i.e. 100%) had shown complete result.

Graph no. 20- showing overall result for growth of hair in 3 sq. cm in females.

Table No48. Statistical analysis before treatment and after treatment .

Sl. Parameter Mean S.D. S.E. t-

value

p-

value

Remarks

01. No. of hair in 3 sq. cm 1.26 .495 .090 14 <0.001 H.S.

02. Growth of hair in 3 sq. cm 2.03 .548 .100 20.09 < 0.001 H.S.

03. No. of hair in 3 sq. cm in males .4 .451 .082 4.87 <0.001 H.S.

04. No. of hair in 3 sq. cm in

females

.83 .617 .112 7.41 <0.001 H.S.

05. Growth of hair in 3 sq. cm in

males

.96 1.026 .187 5.133 < 0.001 H.S.

06. Growth of hair in 3 sq. cm in

females

1.06 .663 .121 8.76 < 0.001 H.S.

All the parameters shows highly significance within the group to assume that the

romashatana lepa has significant depilatory activity in the hair . Over all result in 30

volunteers for number of hair in 3sq. cm area shows complete result. Male and female

showed complete result.

0

5

10

15

20

CR MaR MoR MiR NR

no. of vounteers

Observation & Results

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 103

Table No. 49. Statistical analysis before treatment and on follow up.

Sl. Parameter Mean S.D. S.E. t-

value

p-

value

Remarks

01. No. of hair in 3 sq. cm 1.26 .495 .090 14 <0.001 H.S.

02. Growth of hair in 3 sq. cm 2.16 .444 .081 26.66 < 0.001 H.S.

03. No. of hair in 3 sq. cm in males .4 .451 .082 4.87 <0.001 H.S.

04. No. of hair in 3 sq. cm in females .83 .617 .112 7.41 <0.001 H.S.

05. Growth of hair in 3 sq. cm in

males

.9 .849 .155 5.80 < 0.001 H.S.

06. Growth of hair in 3 sq. cm in

females

1.06 .663 .121 8.76 < 0.001 H.S.

All the parameters shows highly significance within the group to assume that the

romashatana lepa has significant depilatory activity in the hair. The lepa shows complete

result in 28 volunteers (i.e. 93.33%) out of 30 for growth of in hair in 3 sq. cam area

criteria and 2 volunteers (i.e. 6.67%) shows marked result. 17 volunteers (i.e. 56.66%) had

shown complete result for number of hair in 3 sq. cm area and 13 volunteers (i.e. 43.33%)

had shown marked result.

Master Charts

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 104

MASTER CHARTS

Showing subjective parameters

Sl.

No.

OPD

No.

Number of Hair

in 3 sq. cm area

(grades)

Response Hair growth in 3 sq.

cm in mm

Response

BT AT FU BT AT FU

01. 11872 3 2 2 MaR 3 0 0 CR

02. 11883 3 2 2 MaR 3 0 0 CR

03. 11884 2 1 1 MaR 2 0 0 CR

04. 11873 1 0 0 MaR 1 0 0 CR

05. 11880 2 1 1 MaR 2 0 0 CR

06. 11907 2 1 1 MaR 2 0 0 CR

07. 11916 3 2 2 MaR 2 0 0 CR

08. 11914 2 1 1 MaR 2 0 0 CR

09. 11924 1 0 0 CR 2 0 0 CR

10. 11923 1 0 0 CR 1 0 0 CR

11. 12017 2 1 1 MaR 2 0 1 CR

12. 12151 2 1 1 MaR 3 0 1 MaR

13. 12198 3 2 2 MaR 3 0 0 MaR

14. 12228 3 2 2 MaR 2 0 0 CR

15. 12199 1 1 1 MaR 2 0 0 CR

BT – Before treatment, AT – After treatment, FU- Follow up, CR – Complete result, MaR

–Marked result.

Master Charts

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 105

Ctd . . .

Sl.

No.

OPD

No.

Number of hair

in 3 sq. cm area

Response Hair growth in 3 sq.

cm in mm

Response

BT AT FU BT AT FU

16. 12339 1 0 0 CR 2 0 0 CR

17. 12340 2 0 0 CR 2 0 0 CR

18. 12338 1 0 0 CR 2 0 0 CR

19. 12453 2 0 0 CR 2 0 0 CR

20. 12452 1 0 0 CR 2 0 0 CR

21. 12520 2 0 0 CR 2 0 0 CR

22. 12547 1 0 0 CR 2 0 0 CR

23. 12683 2 0 0 CR 2 0 0 CR

24. 17869 1 0 0 CR 2 0 0 CR

25. 17868 2 0 0 CR 2 0 0 CR

26. 17867 1 0 0 CR 2 0 0 CR

27. 17890 2 0 0 CR 2 0 0 CR

28. 17889 1 0 0 CR 2 0 0 CR

29. 17888 2 0 0 CR 1 0 0 CR

30. 17887 2 0 0 CR 2 0 0 CR

BT – Before treatment, AT – After treatment, FU- Follow up, CR – Complete result, MaR

–Marked result.

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 106

DISCUSSION

Discussion is the vital part of the study, observations, interpretations and answers

are outcome of the current study which are discussed as underneath-

1) Review of literature

2) Pharmaceutical Study

3) Analytical Study

4) Clinical Study

Review of Literature:

Romashatana lepa is mentioned in the Sharangadhara Samhita. Sharangadhara stated that

nirmulayati keshastanam kshapanasya shiroyatha. Here by this shloka we can take two

meanings.

First, this lepa causes epilation,i.e it causes hair fall with root and not depilation i.e hair loss

on the skin surface (hair root is intact). By this he did not mean that again hair growth will

not be there as there is no word like Punarnarohanti etc. whenever normal hair falls it falls

with the root only, in fact, produce new hair. So there is every chance of new hair growth,

through this lepa hair falls with roots.

Second meaning is if we consider Moola is a factor which is responsible for new growth ,

then by saying nirmulayti, he is indicating towards germ cell destruction and permanent

romashatana.

As the lepa contains hartala, shankh churna and plasha kshara.

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 107

Hartala

In Rasa classics, majority of Acharyas place it in Uparasa group. Among Brihatrayis, in

Charaka samhita, Harataala has been used for treatment of kusta, unmaada, swasa, kaasa, in

visha, for external application in skin diseases and for mrudu virechana. Two types of

hartala are mentioned by the different Rasa authors (patra harala & pind hartala) among

these patra hartala is uttama. Hence widely used for medicinal purposes than pinda hartala.

Hartala is equated with orpiment or arsenical gold and are chemically known as Arsenic Tri

Sulphide. Arsenic is a local irritant acting slowly on tissue.

In Bhaishjya ratnavali one of the synonyms of the hartala is romaharna. It means it causes

the hair removal. Hartala shodhana was carried out in the churnodaka which is calcium

hydroxide, the property of the churnodaka was incorporated to the hartala. In modern

science thioglycolates are used in a concentration of 2-4% for depilation. Calcium salt is the

most favoured of all the thioglycolates as it is least irritant. An excess of calcium hydroxide,

which also acts to prevent the excess alkalinity known to irritate skin, maintains the pH.

From the above references it is clear that for the best action of depilation alkaline medium

is required and which does not irritate the skin.

Shankha :

Rasarnavakar is the person who considered Shankha under Shukla varga may be of its

white colour. Shankha is the outer covering of “Molluska group” of aquatic animal which

are seen in sea. It is collected from the sea, and put in boiling water. The animal which is

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 108

present inside dies and the outer portion is Shankha. It has an external lustrous yellowish

brown horny layer and beneath it has a thick layer, chiefly formed of Calcium carbonate.

In modern science thioglycolates are used in a concentration of 2-4% for depilation.

Calcium salt is the most favoured of all the thioglycolates as it is least irritant. An excess of

calcium hydroxide, which also acts to prevent the excess alkalinity known to irritate skin,

maintains the pH.

From the above references it is clear that for the best action of depilation alkaline medium

is required and which does not irritate the skin.

Palasha kshara:

As mentioned above the best action of depilation alkaline medium is required. So it is a

kshara which will enhance the depilation activity. It will maintain the pH of the skin and

produce less irritation.

Pharmaceutical Study:

Most of the times metals and minerals are found in the compound form i.e. mixed with other

ingredients. Some of them may be unwanted and toxic in nature including effective

ingredients.

Shodhana not only intended to remove impurities or toxic materials but also makes

the metal or mineral suitable for further procedure. It may enhance its property or it reduces

its particle size.

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 109

To prepare the selected trial drugs strictly according to Classical references as many as 4

practical’s were carried out. They are discussed below one by one.

Practical no. 01

Shankha churnikarna

Before subjecting it to churnikarna the prakshalana was done with hot water which is one

of the shodhana modalities. Then after that pounding was done it was made into churna and

sieved through sieve no. 120.

Here loss is due to prakshalana, pounding and filtering.

Practical No 02

Hartala shodhana

Hartala shodhana was carried out. As hartala is toxic in nature, to get ride off and also to

get the qualities of liquid media which was used as bhavana dravya for Shodhana of hartala

was done and after drying it was pounded to churna and sieved through sieve no. 120.

Here is loss is due to shodhana, pounding and filtering.

Practical No 03

Preparation of palasha kshara

The kshara was prepared by following the methods described below obtain the best

kshara. The palasha stem were burnt to ash and 6 times water was added. Then it was

kept for overnight. Then it was filtered through the three folded cloth for 21 times so as

to get the ksharodaka. After that it was dehydrated. To obtain the kshara.

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 110

Practical No 04

Preparation of romashatana lepa

All the ingredients shankh churna- 3part , hartala churna- 1 part, palasha kshara – 1

part were mixed thoroughly to get the homogenous mixture.

Careful mixing was done to avoid the loss.

Analytical Study:

This part exposes the hidden facts about the final product when it was critically analysed

with the help of physical and chemical parameters.

Organoleptic characters: romashatana lepa is buff coloured.

pH- report showed that pH was 8.78 in recommends that romashatana lepa the final

product is alkaline.

Loss on drying at 1100C It shows the end product contain 1.25% of moisture.

Loss on Ignition: 18.85 % shows organic material in romashatana lepa .

Total Ash: The herbomineral drugs were converted into ash form resulting into weight

loss. Here value of weight loss noted in 81.15 %. Higher value may be due to the

palashakshara.

Acid Insoluble Ash: is 8.89% it indicates the low acid insoluble acid ash values facilitates

the easy absorption of drug.

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 111

Fineness of particles : 84.43%passes through the sieve no.120This shows the particle size

are fine in nature, which is able to enter into the small capillaries and rate of absorption of

drug is directly proportional to the particle size of drug the particle size is fine so the

absorption is quick.

Solubility test:

It is 16.72% soluble in alcohol and 5.52% soluble in water. By this it is understood

that may be absorb slowly in GIT

Assay for Arsenic and Calcium:

The percentage of arsenic and calcium was assayed in the romashatana lepa , which

revealed that arsenic was present in 2.31% and calcium was present in 22.0%.

Mode Of Action Of The Individual Drug

Hartala

Mentioned as romaharna

As haratala is mentioned as romharana. Because of this property it helps for the depilation

activity of Romashatana lepa.

Hartala

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 112

Shankha

Mentioned as vilekhana

As shankha karma mentioned as vilekhana because of this vilekhana property it helps for

the depilation activity of Romashatana lepa.

Palasha Kshara

Possess the ksharana property

As the kshara possess the ksharana property because of this ksharan property it helps for the

depilation activity of Romashatana lepa.

As the analytical report says that the Romashatana lepa have the alkaline pH. because of this

it helps in the depilation activity.

Probable mode of action of the drug:

The toxicological mechanism in organic Arsenic differs for the trivalent and pentavalent

forms. For trivalent Arsenic inhibition of the pyruvate dehydrogenase(PDH) complex is the

primary bichemical lesion. Dysfunction of this complex, which is comprised of the three

enzymes occurs when As3+

binds to sulfahydril group of dihydrolipoamide preventing

Shankha

Palasha Kshara

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 113

regeneration of lipoamide, which is a necessary cofactor in the conversion of pyruvate to

acetyl CoA levels, inturn, reduce citric acid cycle activity with resulting decreased

production of ATP. Direct effects As3+

on alpha- ketoglutarate dehydrogenase complex,

which contain a dihydrolipoyl dehydrogenase identical to that PDH complex, further reduce

citric acid cycle activity.

As3+

also interfers with Glucose production and uptake, the drop of acetyl CoA levels,

discussed above, also inhibits the activity of the pyruvate carboxylase, which catalyzes the

conversion of pyruvate to oxaloacetate, the initial step in gluconeogenesis. Animals studies

demonstrate that As3+

has the greatest effect on gluconeogenesis from pyruvate with lesser

effects on gluconeogenesis from other substances such as lactate, aminoacids, glycerol.

Impaired gluconeogenesis combined with carbohydrate depletion due to stress of poisoning

can result in hypoglycemia. Arsenic also effect other sulfahydral containing enzymes,

including membrane transport enzymes involved with insulin dependent cellular glucose

uptake. Thus cellular lack of glucose may be a consequential problem in As3+

poisoning

although it remains unproven in humans.

From the above we can draw an inference that the romashatana lepa works by

decreasing the cellular energy level & thereby leading to decreased mitotic activity and

cessation of hair follicle formation. As mentioned above the shanka and palasha kshara

provides the alkaline medium to facilitate the depilation activity of romashatana lepa

Discussion on clinical study.

Effect on the number of hair in 3 sq. cm area.

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 114

60% of the volunteers showed no hair in the 3 sq. cm area after and on follow up

reported statistically significant where p value is < 0.001.

Effect on growth of Hair in 3 sq. cm area.

100% of the volunteers showed no hair growth in 3 sq. cm area after and on follow

up

reported statistically significant where p value is < 0.001.

Effect on the number of hair in 3 sq. cm area in males

53.48% of the volunteers showed hair in the 3 sq. cm area in grade 1 after and on

follow up reported statistically significant where p value is < 0.001.

This may be due to that males are usually atiloma so the number of hair is reduced to nil

was not seen.

Effect on growth of Hair in 3 sq. cm area in males

100% of the volunteers showed no hair growth in 3 sq. cm area after and 84.61% on

follow up reported statistically significant where p value is < 0.001

This may be due to that males are usually atiloma so the number of hair is reduced to nil

was not seen in 15.38% of volunteers.

No untoward effect was seen during the treatment.

Effect on the number of hair in 3 sq. cm area in females

100% of the volunteers showed no hair in 3 sq. cm area after and on follow up

reported statistically significant where p value is < 0.001.

Discussion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 115

Effect on growth of Hair in 3 sq. cm area in females.

100% of the volunteers showed no hair growth in 3 sq. cm area after and on follow

up reported statistically significant where p value is < 0.001.

Total effect :

Number of hair in 3 sq. cm area

56.66% shows complete relief.

43.33% shows marked relief.

Number of hair in 3 sq. cm area in males

100% shows marked relief.

Number of hair in 3 sq. cm area in females

100% shows complete relief.

Growth of Hair in 3 sq. cm area

93.33% shows complete relief

6.67% shows marked relief.

Growth of Hair in 3 sq. cm area in males.

84.61% shows complete relief.

15.38% shows marke relief.

Growth of Hair in 3 sq. cm area in females

100% shows complete relief.

Conclusion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 116

CONCLUSION

Romashatana lepa is the Kharaliya rasayana

1. Pharmaceutical study:

Shankh prakshalana with hot water, helps to remove the external impurities.

Churnikarna reduces the shankh into finer particles so that it can be easily absorbed

through the skin to produce its desired effect

Shodhana of hartala, with churnodaka, certainly have a role in detoxifying and

potencifying drugs.

2. Analytical study:

Romashatana lepa is buff coloured which is 5.52% soluble in water and 16.72%

soluble in alcohol

Loss on drying is revealing the presence of moisture content may be due to palasha

kshara.

Total ash reveals the presence of moisture.

Fineness of particle size signifies rate of absorptions..

The total arsenic 2.31% w/w and calcium (22.0% w/w) of romashatna lepa is near to

the standards specified.

pH value is 8.78 shows that which is alkaline in nature

.

Conclusion

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 117

3. Clinical Study

The result reveals that romashatna lepa has got good depilation activity.

There was no untoward effect seen during the study

Limitations

1. The period of study was limited.

2. Limited to that of one particular geographical area.

3. Longer follow up was not done.

Further scope

Of present clinical study was best choice to see the depilation activity in the foot

hairs.

A separate study with application to other areas of the body should be done like

females mostly have unwanted hair in the upper back so there it should be tried.

Regional variation should be kept in mind for the further studies. Within

India also there is regional variation in hair. In Kerala people have long and thick hair,

where as the people of Rajasthan and Tibet do not have such long and thick hair .In long

hair the mitotic activity of germ cells is more. So the growth is more. To cause the

permanent romashatna of the hair of Keralian more potent medicines may be required, as

compare to the hair of Rajasthan or Tibetian, as it has to destroy the germ cell activity.

Summary

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 118

SUMMARY

The present dissertation work entitled “PHARMACEUTICO

ANALYTICAL AND CLINICAL STUDY OF ROMASHATANA LEPA W.S.R. TO

ITS DEPILATION ACTIVITY.” deals with topics such as introduction, review of

literature, methodology involves study of pharmaceutical, analytical and clinical methods

employed during the present work, along with observations, results, discussion and

conclusion.

Introduction

The introduction covers need of the study description of Romashatna lepa. Hair

anatomy and physiology, the purpose of the study in present scenario were discussed

briefly.

Review of Literature

This aspect of literary review dealt with drug , composition of the trial drugs and

their properties, distribution, pharmacological properties, Bhaya kalpana, and the different

techniques for the depilation.

Pharmaceutical study

This deals with selection of raw materials, churnikarna of shankha, shodhana of

hartala, preparation of palasha kshara. Preparation of the ingredients of the romashatna lepa.

Summary

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 119

Analytical study

This deals with organoleptic characteristics, , pH assay, Loss on drying at 1100C,

Loss on Ignition,Determination of Total Ash, Acid Insoluble Ash, Determination of

Fineness of particles , Solubility Test, Estimation of Arsenic, Estimation of calcium.

Clinical study

This part deals with materials and methods. It contains research approach, research

design, selection criteria, diagnosis criteria, treatment schedule and criteria for clinical

assessment.

In this part results obtained are systematically presented, which are demographic

data, and data related to response to the treatment.

Result

The results are statistically analyzed, explained and presented in the form of tables

and graphs.

Discussion

This part deals with logical interpretation of results. An attempt was made to discuss

review of literature, pharmaceutical studies, analytical studies, clinical studies and probable

mode of action of romashatna lepa .

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Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 120

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ANNEXURE

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 139

SPECIAL CASE SHEET FOR DEPILATORY EFFECT OF ROMASHATANA LEPA IN FOOT HAIR

Post Graduate Research And Studies Center (Rasashastra) Shree DGM Ayurvedic Medical College, Gadag.

Guide: Dr. J.G.MITTI M.D,PhD(Ayu) H.O.D: Dr. M.C.PATIL. M.D(Ayu)

P.G.Scholar: Dr. Dinesh Gupta

1. Name of the patient : ____________________

2. Father’s / Husband’s Name : ____________________

3. Age _______ yrs. Place of Birth __________________

4. Sex Education __________________

5. Marital Status Married ( ) Unmarried ( )

6. Religion Hindu ( ) / Muslim ( ) / Christian ( ) / Others ( )

7. Occupation Labour ( ) Student ( ) Executive ( ) Sedentary ( )

8. Economical Status Poor ( )/ Lower Middle ( ) / Upper Middle ( )/ Rich ( )

9. Address _______________________ E-mail ID _____________

_______________________ Phone No _____________

_______________________ Pin __________________

D M Y D M Y

10. Date of commencement of treatment: Completion:

11. Result:

CONSENT

I am fully educated with the disease and treatment thereby I got satisfied. I accept for medical trial on me

happily.

Signature of patient / Thumb impression

M

SL.No

O.P.D. No

I.P.D. No

F

ANNEXURE

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 140

Criteria for observation (Romashatana lepa in Foot Hair)

Personal History:

Number of Hair in 3 sq. cm area

Grade 0 (No hair)

Grade 1(1-5hair)

Grade 2 (6-10 hair)

Grade 3 (11-15 hair)

Grade 4(16-20 hair)

Grade5 (21& >21 hair)

Before treatment

After treatment

Follow up

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

ANNEXURE

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 141

Growth of hair in 3sq. cm area (in mm)

Grade 0 (0) -

Grade 1 (1-2) -

Grade2 (3-4) -

Grade 3 (5-6) -

Grade 4 (7-8) -

Grade 5 (9&> 9) -

Before treatment

After treatment

Follow up

Mode of administration: External application

Dose : As required

Treatment duration: 7 days

Follow up: 14th

day

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5

ANNEXURE

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 142

Skin Changes

S.no Observation 1st

Day

2nd

day

3rd

day

4th

day

5th

day

6th

day

7th

day

14th

day

01 Itching

02 Redness

03 Hot sensation

04 Eruptions

Nil

Vesicular

Macule

Maculopapular

05 Discharge

Nil

watery

Pus

Blood

ANNEXURE

Pharmaceutico analytical and clinical study of romashatana lepa w.s.r. to its depilation activity. Page 143

Result :-

No. of hair in 3sq. cm area.

Growth of hair in 3 sq. cm area.

Signature of Guide : Dr. J.G.MITTI M.D,PhD(Ayu)

Signature of H.O.D : Dr. M.C.PATIL. M.D(Ayu)

Signature of Scholar : Dr. Dinesh Gupta

Complete relief Marked relief Moderate relief Mild relief No relief

Complete relief Marked relief Moderate relief Mild relief No relief

PHARMACEUTICS OF ROMASHATANA LEPA

Fig.7- Hartala Shodhana Fig.8- Burning of palasha stem Fig.9- Palasha Ash

Fig10 – Filteration of ksharodaka Fig11- Dehydration of ksharodaka Fig12- Palasha Kshara

Fig13- shankha churna Fig14- Hartala Churna Fig15- Romashatna lepa

CLINICAL STUDY

Volunteer 1 Volunteer 2

Fig15- Before Fig16- Before

Fig16- With Application Fig17- With Application

Fig18- Follow Up Fig19- Follow Up

RAW DRUGS

Fig.3- Shankha Fig.4- Shankha Churna

Fig.5- Raw Hartala Fig.6- Hartala Churna

Fig.6- Palasha stem