Ayurvedic Research: The Need for a Paradigm Shift

1. Ayurvedic Research – need of paradigm shift Prof. M. S. Baghel Ex Ayurveda Chair, Debrecen, Hungary Ex Director, Institute for P G T & Research in Ayurveda Gujarat Ayurved University , Jamnagar, India E mail : baghelayu@rediffmail.com

2. RESEARCH • Research should be a process that converts data into information, information into knowledge and knowledge into wisdom. This is like transforming milk into ghee. • It should be more balanced and comprehensive. There should be equal emphasis on literary, field, experimental and clinical research. • It should be able to impact the fields of education, pharmacy and practice in a profound way. Present day Ayurvedic Researches are failing in this respect as they are unable to disseminate the knowledge gained from the researches.

3. RESEARCH & PUBLICATION • Any research work becomes valid and widely accepted when it is published in peer reviewed journals. • Documentation and publication of research findings is the main issue faced by Ayurveda in the global arena. • There are many scattered evidences for the safety and efficacy of Ayurveda drugs lying with many practitioners and researchers and non governmental bodies.

4. INDIAN INDIGENOUS DRUGS - RETROSPECT -PROSPECTRANITA AIMAN Ind. J. Pharmac., 11 (1) I-12 (1979) CHOPRA MEMORIAL ORATION 1978, delivered at AIIMS • The subject of Indigenous Drugs, ----- therefore, like “Sleeping Beauty” after a long hibernation of centuries during which it was frequently proded by hakims and vaidyas, was quickened into life by several sparks. • It is probable that no ‘Magic Drug’ as penicillin was called, will be discovered in the MateriaMedica of the ancients, as their system of medicine was based on the Tridosha theory • Future Prospects -Is it bleak or bright? Will the “Beauty” go to sleep again, this time perhaps forever? If I am permitted to dip into the future, I foresee a ‘come-back’ of some of the older native remedies in perhaps a new garb, either as single active principles, or a derivative, or even as relined preparations of the crude drugs,

5. Progress of modern herbal research • National Institute for Tropical medicine • ICMR • CDRI – Screening of medicinal plants for their biological activity 1963 -1975, more than 2000 plants screened

6. Why Research in Ayurveda? • Globalization of Ayurveda • Increasing demand of ‘evidence-based Ayurveda • Industrialization of Ayurvedic drug sector • Classical formulations loosing ground • Convince the users regarding safety of drugs • Drug standardization & quality assurance • To develop new drugs & formulations • To develop new indications • Need to explain & increase the understanding of fundamental principles • To develop and understand Ayurveda further

7. WHY DO WE NEED CLINICAL TRIALS • Revalidation of facts enumerated in Ayurvedic classics • To establish Dose, Duration, Indication & Side-effect profile of any given Drug • To find out new better treatment modalities for the diseases • To find out newer source material for scarce/ endangered medicinal plants • To find out pharmacological basis of mode of action • To standardize the treatment procedures scientifically • For Regulatory approval, Registration purposes & for proof of efficacy

8. Organizations conducting research in the fields related to Ayurveda • Ayurvedic PG institutions • CCRAS • ICMR, CDRI, AIIMS, NIMHANS SOME OTHER MEDICAL UNIVERSITIES • DST, CSIR – IGBI, • Some Universities and Institutions conducting biomedical researches • NGOs

9. STATUS OF AYURVEDIC RESEARCH • 2000 PG theses per year at various Institutes and hardly 200 research papers pertaining to these researches are published per year in Ayurvedic journals . • 100 Ph.D. Theses in faculties of Ayurveda and data of less than 50% is being published • Nearly only 50 PhD scholarships are available for Ayurveda, IPGT and NIA other than newly sanctioned AYUSH scholarships Whether to accept these researches as reference material or not ?

10. Present Status of outcomes of researches • The out come of Ayurvedic researches has not yet tickled to the use and benefit of students and practitioners of Ayurveda • Sectarian knowledge promotion and boost is not taking place • Sectarian interest are not preserved properly • All research activities are done by blindly following the modern trends • No set guideline available in Ayurveda to strengthen the knowledge of the science.

11. Suggestions of Dr. SR Narahari, IAD, KasargodThe occasion was the 22nd Cochrane Collaboration colloquium. • What are the methods needed to create evidence in Ayurveda? which study designs should be adopted?  • should RCT lead ayurveda';s evidence? Cochrane recognizes nothing less than RCTwould it be possible to develop a core methods group? • How to structure the clinical studies in ayurveda? how to determine the sample size?  • How this methods group should be empowered to achieve the capacity building of tens and hundreds of ayurveda doctors interested in evidence based ayurveda movement? Is it possible to initiate systematic reviews  programs on the side lines of many CMEs and conferences held across the country so that the voluntary collaboration swells over the time • If ayurveda is effective then we will have to show case its ability to alter the natural course of the disease. If so what kind of documentation we must begin? 

12. Clinical studies – selection of study design • Controlled studies • Open trial • Single Blind trial • Double Blind trial • Single – case design • Black box design studies • Observational studies

13. Questions… solutions…. There is a need of paradigm shift in strategy & methodology of research in Ayurveda. • Many fold research requirement in Ayurveda i.e. • first one for the science of Ayurveda and • the second one is for therapeutics in Ayurveda. • Improve the under standing of Ayurveda in light of newer basic sciences • Convince the modern medical world regarding therapeutic efficacy of Ayurveda • Ayurveda has to be studied and investigated as it is, critically adapting an Ayurvedic approach in tune with its basic principles, however the technical tools can be borrowed from modern basic and biosciences.

14. Some questions… solutions…. • Trust, Truth and Team are the basic requirements for any research activity. • There is a need of new strategy & methodology of research in Ayurveda. • The strategy of research which nourishes the science of Ayurveda lagging since last 2500 years • However proving it scientific in the eyes of so called modern medical fraternity which is widely controlled by pharmaceutical Industry • Convincing biomedical scientists who want Ayurveda without Ayurvedists

15. Problems Of Clinical Researches In Ayurveda - Planning Of Research Works • Understanding of fundamental principles of Ayurveda • Selection of subject • Diagnostic approach • Use of Quality of life parameters as assessment criteria as mentioned by Charaka (Vi 8) – Rogabala, Dehabala, Agnibala, Chetasabala • Dependency of researches on symptomatology • Understanding of Ayurvedic classical terminologies and their grading

16. Solutions for improvement • Create a consensual Ayurvedic research methodology suitable and useful to Ayurveda • National grading system for Ayurvedic terminologies • Preparation of ICD -11 compliant Ayurvedic disease classification • Incentive for doing regular in house Ph.D. • Institution of yearly awards for publication of best Ayurvedic data • Updation of in house research journals of CCRAS, NIA, AYUSH to create better data base

17. Global research requirements • Life style diseases ,their prevention and management • Pharmacological researches in the field of known herbs • Research in the field of Panchakarma and Yoga • Study of local flora for Ayurvedic pharmacodynamics • Research in the field of food technology to develop new food products from herbs used in Ayurveda • Research in the field of Agriculture technology to grow the plants in their countries which are useful in Ayurveda

18. Consideration of fundamental principles of Ayurveda while designing clinical trials • Consideration of DoshikPrakriti • Consideration of ManasikPrakriti • Consideration of Doshik Variants of diseases, status of Agni, Koshtha, AmapakvaAvastha of diseases • Dose – variation as per conditions, doshik status, Agni, Koshtha, age, prakritetc • Administration timings – Aushadhi Kala • Anupana, Sahapana • Pathya-Pathya • Dosages format • Employment of proper medical statistician who can guide the sample size

19. Areas from classical Ayurveda requires further exploration/updation • Updation of Nanatmaja disease list (Avishkritatamah) • Development of diagnostic tools for 63 combination and permutation of Doshas • Study and finalization of Samprapti of newer diseases so that Chikitsasootra can be formulated • Clinical trials should be organised on priority diseases applying full classical Chikitsasootra • Inclusion of newer herbs in Ayurvedic materiamedica by studying there Rasa, Gunadi- pharmacodynamics • Study of newer dosage pharmats like capsule, injections etc in Ayurvedic pharmaco-dynamics

20. Suggestions for the improvement of research outcomes • Consistent quality of products • Proper description of SOP of the trial drugs • Sincere efforts required from all the agencies to improve the quality of Clinical Trials • Compliance of GCP, GAP, GMP, GEP, guidelines

22. Newer science areas to be studied and understood in field of Ayurveda • Genomics • Epigenetics • Proteomics • Metabolomics • Gut Brain syndrome • Psycho-neuro-immuno-endocrinology • System biology • Xenoharmesis

23. Area of Clinical Research • Diseases of National Importance • Malaria, Filaria, Goitre, Tuberculosis, AIDS • Life style disorders • Hypertension, DM, Cardiac diseases, OA, Obesity • Allergic & Auto Immune disorders • Bronchial Asthma, Bronchitis, Globinopathies • Metabolic and collagen disorders like – Rheumatoid arthritis • Incurable & Chronic diseases of Global importance CAM • RA, Cancer, Alzhiemers, Parkinson,Degenerative Neurological diseases • Primary Health Care level managements • Pregnancy Pre & Post natal care, Childcare, management of common clinical conditions • Better health achievement for general people

24. AVAILABILITY OF ELECTRONIC / PUBLISHED DATA BASE : • CCRAS Data base in Book format • CSIR in electronic format and Book format not exhaustive and does not includes researches done at Ayurvedic Institutes due non publication of these in Scientific Journals • ICMR – DATABASE • AYATA NIDANA (Diagnostic soft ware) developed by Tilaka Maharashtra Vidyapeeth, Pune in collaboration with CSIR • Ayusoft – data base of Pune university based CDAC • AHEAD ( Wealth of Asia Not updated since 1998) • RUDRA – software based data base of • www.Researches-in-Ayurveda- A classified directory of PG & PhD. thesis’s of Ayurveda (M S Baghel & Girish K J contains titles only containing more than 20000 PG/PhD theses titles • Shodhaganga – UGC sponsored data base of PhD theses containing titles and full theses