ayur research vision 2020

Ayurveda Research Vision 2020

Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/

Ayurveda Research Vision 2020 @ DrBRKR

GAC, HYD, 26-03-14

“Research is creating new knowledge.” -Neil Armstrong


GAC, HYD, 26-03-14

Dr. K. Shiva Rama

Prasad, at http://www.technoayurveda.com/

Is Ayurveda Research is necessary?


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


“Research is formalized curiosity. It is poking and prying with a purpose.

”

-Zora Neale Hurston

What for we have to do Research?1) To conform the past experiences2) To exclude the selected past not

relevant to the present 3) To include the new concepts /medicines

/ procedures / experiences4) To include new herbs in to Ayurveda


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Problems associated with clinical trials of Ayurvedic medicines


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Ashish

K Sharma et.al., Problems associated with clinical trials of Ayurvedic medicines, Rev. bras. farmacogn. vol.20 no.2 Curitiba

Apr./May 2010, http://dx.doi.org/10.1590/S0102-695X2010000200023

Integrated approach of many herbal systems does not differentiate the disease from the patient.

Ayurveda proposes different interventions at different stages of disease in the same patient providing another difficult to control variable in a clinical trial.

Herbal medicines used in traditional systems are used in the humans without any toxicity studies, their embryotoxic, foetotoxic, and carcinogenic effects are likely to remain unrecognized in traditional practice

With Ayurvedic medicines, it is difficult to plan double-blind randomized clinical trials. For clinical evidence of safety and efficacy the placebo-controlled, double blind randomized trial may be considered as gold standard,

"there is no scientific evidence to prove that Ayurvedic medicine can treat or cure Cancer". -

Cancer Research UK,

"Most clinical trials of Ayurvedic approaches have been small, had problems with research designs, or lacked appropriate control groups, potentially affecting research results.“-

U.S. National

Institutes of Health states

Ayurvedic drug manufacturers believe that GMP / GCP are not practical and should not applied to Ayurvedic drugs, as it would involve a huge amount of cost.

http://en.wikipedia.org/wiki/Clinical_trials_on_Ayurvedic_drugs


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Ayurvedic parameters like Tridosha, Panchamahabhuta, Agni, Guna, Veerya, Vipaka, Prabhava, Avarana, etc. have to be taken in to account along with contemporary scientific parameters in the research of Ayurveda

Inclusion and exclusion criteria, end points, markers and methodology should be based on ASU philosophy

Clarity and Guidance for compliance on issues like active ingredients, chemical names, impurity profile, excipients, etc. also to be provided.


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Nagesh Sandu, AYUSH GCP : INDUSTRY PERSPECTIVE, Director Sandu

Brothers Pvt

Ltd Mumbai

What are the challenges faced during Clinical trials of

Ayurvedic and traditional medicines?


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Formulations: It can be challenging to know which components are having an effect and why.

Interactions: Whenever two or more medications are used, there is the potential for them to interact with each other.

Scientific evidence.: Most clinical trials are small, had problems with research designs, lacked appropriate control groups, or had other issues that affected how meaningful the results were.

Facts


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


"Of the 166 plants investigated, 72 (43%) had at least one or more human studies and 103 (62%) had one or more animal studies. These results appear to contradict

There are difficulties in estimation of "active" molecules in body fluids in the pharmacokinetic studies in phase I of drug development especially in Ayurvedic formulation.

Storage conditions can also alter the bioavailability of herbal medicines, which may lead to loss of activity, fungal or bacterial contamination


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Avoid the herbs have been reported to be poisonous in planning of clinical trials

Ayurvedic HMPs

(Herbal Medicinal Products) are marketed as dietary supplements (In the west)

Many a times the medicine system advocates other procedures along with oral therapy which again may or may not be standardized.

crude raw herb material has number of variations as per geographical locations, climatic conditions, environmental hazards, harvesting methods, collection protocols, etc

Thus -

a uniform research policy in herbal medicines is need of the hour.

Ashish

K Sharma et.al., Problems associated with clinical trials of Ayurvedic medicines, Rev. bras. farmacogn. vol.20 no.2 Curitiba

Apr./May 2010, http://dx.doi.org/10.1590/S0102-695X2010000200023

Guidelines for ASU Drugs


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Ayurveda drugs Manufactured in accordance with formulae as per the definition given in clause (a) of Section 3 of the Drugs and Cosmetics Act, 1940.

Indian Ethno-medicines based drugs not covered under Categories I and II IV. Medicines based on extracts of medicinal plants of India

GUIDELINES FOR PRE-CLINICAL SAFETY EVALUATION FOR AYURVEDA


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


SUB-CHRONIC TOXICITY TESTS

Observations and examinations,

General signs, body weight and food and water intake

Hematological examination

Renal and hepatic functions tests

Recovery from toxicity


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


DATA REQUIRED TO BE SUBMITTED WITH APPLICATION FOR PERMISSION TO CONDUCT CLINICALTRIALS ON AYURVEDA


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Information on the formulation (s)

2.1 Composition

2.2 Dosage from

2.3 Rational with relevant reference

2.4 Method of Manufacture

2.5 Standardization Parameters

Experimental Pharmacology (as the requirement may be)

3.1 General pharmacological actions

3.2 Specific pharmacological actions

Safety data (as the requirement may be)

4.1 sub-chronic

4.2 Genotoxicity if required (as per Schedule Y).

Investigator brochure, Protocol, Case Report Form, Patient Information Sheet, Informed consent form (English and local language)

Footnote: The principle rules were published in the Gazette of India vide notification number F. 28-10/45-H(I), dated the 21st December, 1945 and subsequently amended vide

notification number: -

(1) GSR 755 (E) dt. 23.10.2008

OBJECTIVES


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Research on Fundamentals of Ayurveda, its principles and practices including Literature Research

Clinical research: Validation of clinical efficacy of Classical Ayurvedic Formulations on priority basis including Ayurvedic Diagnostics and Preventive Health Care.

Drug Research and Development based on Ayurvedic principles and Experimental leads

PRIORITY AREAS


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Fundamental Research i. Tridosha, Prakriti, Agni, Dhatu, Ojas, Srotas,

Ama, Samprapti

& Khad

Kriya-Kala

etc.

ii. Rasa, Guna, Virya, Vipaka

and Prabhava

iii. Literature Research; Survey, collection, transcription / translation and preparation of classical literature and text books, Medico-

historical investigations of Ayurveda

Selection of topic


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Drug Research and Development

i. Standardization and Quality Assurance

ii. Pharmaceutical Research and Development

iii. Pharmacology [In-vitro & in-vivo methods]

iv. Biomarker based Mechanism of action

v. Ethno-medicinal Research: survey and documentation of medicinal plants/practices etc.

vi. Veterinary Ayurveda products

Clinical Research


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Broad Areas

Development of Methods and modalities for Ayurvedic Clinical research

Development of protocols for Clinical Trials

Epidemiological Research

Promotive and Preventive Health Care

R & D on Ayurvedic Diagnostics( including Prakriti

and Nadi

Pariksha)

R & D on Panchakarma and standardization of its procedures.

Diseases /Areas based on strength of Ayurveda, National priorities

i. Preventive Cardiology � Atherosclerosis � Hypertension � Dyslipidemiaii. Gastro intestinal disorders � Hepatic Disorders � Diarrhoeas

and Chronic Enteropathies

iii. Musculo-skeletal disorders � Osteoporosis � Osteoarthritis � Rheumatoid Arthritis iv. Eye diseases � Diabetic Retinopathy � Computer Vision syndrome

v. Metabolic Syndrome and obesity vi. Diabetes Mellitus vii. Skin diseases viii. Respiratory diseases ix. Generalized Anxiety Disorder x. Anaemiaxi. Malaria xii. BPH, Urolithiasisxiii. Fistula-in-ano, Para-surgical

procedures xiv. Neurological disorders and Neuro-

degeneration

xv. Rasayana therapy& Geriatrics xvi. Reproductive & Child Health xvii. Quality of life (QOL) in cancer

patients


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


METHODOLOGY AND APPROACH


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Phase-

I: Healthy volunteers or subjects (20-100). Not required for classical Ayurvedic formulations. This phase may be conducted on case to case basis, wherever required.

Phase-

II & III: Subjects (several hundred), direct phase II &III studies will be conducted.

Phase-

IV: Subjects in select disease conditions (Several hundred to several thousand for assessing quality of life). This phase may be conducted on case to case basis, wherever required.

Statutory, Ethical and Research guidelines:


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Clinical trials should follow the prevalent statutory, ethical and research guidelines like GCP guidelines prevalent in India and the collaborating centres

and these trials

will be registered with Clinical Trial Registry of India (CTRI).

Preclinical studies:


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Though the Preclinical studies on the Ayurvedic classical formulations is not necessary since they are in use for many years.

However, pre-clinical studies will be conducted on these formulations on case to case basis.

Quality control studies and pre clinical Safety/toxicity studies will be conducted at CCRAS & PLIM and outsourced through NABL/GLP compliant laboratories.

Procurement of trial drugs:


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Trial drugs for the projects will be procured from CCARS peripheral institutes and reputed GMP compliant industries.

IMPCL/PLIM/ any state government undertaking will also be one of the sources for trial drugs.

Levels of Evidence


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Evidence


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Need of new research methodology for Ayurveda


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


EBM clinical trial regimens limit the use of Prakriti, Dosha Anubandha-

Anubandhyatwa, Arambhaka

and Anugami Dosha Vikalpa, Swanidana

Prakopa

Awaranajanya

Prakopa, Prakriti SamaSamveta-Vikritishamasamveta,

Amavashthapakvavastha, which leads to variation of dose, dosage form, Aushadhikala, Anupana, Sahapana, Pathyapathya, therapeutics like Panchakarma procedures to be adopted, etc.

M. S. Baghel

http://www.ayujournal.org, AYU | Jan-Mar 2011 | Vol 32 | Issue 1

http://www.ayujournal.org/

The clinical trials in Ayurveda are needed for–


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


Revalidation of facts enumerated in Ayurvedic classics leading to the explanation of fundamental principles;

to find out better treatment modalities for the existing diseases and for newer diseases;

to standardize the treatment procedures scientifically and

to establish dose, duration, indication and side-effect profile of any given drug.

M. S. Baghel

http://www.ayujournal.org, AYU | Jan-Mar 2011 | Vol 32 | Issue 1

http://www.ayujournal.org/

CTRI registration


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


The Clinical Trials Registry -

India (CTRI), an online system (www.ctri.nic.in) for the registration of clinical trials being conducted in India, has its secretariat at the National Institute of Medical Statistics of the Indian Council of Medical Research in New Delhi.

You may reach this site from Gateway of –

www.technoayurveda.com

The CTRI performs quality assurance on submitted entries, and has a mechanism for obtaining updated data and as well as performs de-duplication of submitted trials.

Dr. K. Shiva Rama



GAC, HYD, 26-03-14


GAC, HYD, 26-03-14

Dr. K. Shiva Rama


ayur research vision 2020

Health & Medicine