Clinical Research Protocols for Traditional Health Sciences

Foreword Ayurveda and Siddha have been in vogue in this country from the earliest times, serving the medical needs of most of our people. These systems were developed by ancient scholars on the basis of their own philosophy, oriental methodologies and practices prevalent in that era and have popularized and almost completed it in all aspects as a system of medicine. The advent of foreign invasion and cross interaction had definite impact on these systems.

The worldwide interest in the use of natural products and plant-based remedies had led to different situations developing in different countries. In countries with a strong foundation of traditional medicine such as India and China, nationally recognized parallel traditional systems have run for long periods, along with Western medicine with varying degrees of acceptance, integration and assimilation.

During. the last decade, use of traditional medicine has expanded globally and has gained popularity. It has not only continued to be used for primary health care of the poor in developing countries, but has also been used in countries where conventional medicine is predominant in the national health care systems. With the tremendous expansions in the use of Ayurveda and Siddha world wide, the safety and efficacy as well as quality control of herbal medicines and traditional procedure-based therapies have become important concerns for both health authorities and the public. Various practices of traditional medicine have been developed in different cultures in different regions without a parallel development of international standards and appropriate methods for evaluating Ayurveda and Siddha systems of Medicine. Like other systems of ancient India learning Ayurveda was discovered through most suitable sources (Pramanas) viz. (1) Pratyaksha (direct perception), (2) Anumana (logical inference), (3) Aptopadesa (verbal and authentic documentary testimony) and (4) Yukti (experimental evidence) etc.

In modem medicine, a clinical trial is almost always undertaken to test the efficacy of pharmaceutical products (drugs, devices etc.) and sometimes to study the efficacy of 'non- therapeutic interventions'. The global acceptance of modem system of medicine as a whole is because it has been reviewed systematically by modem scientific parameters. Similar scientific evidences through clinical trials are the need of time, to make the traditional medical systems scientifically acceptable by all.

While designing the research trials it would be appropriate to understand differences between Ayurveda Siddha and Contemporary Modem System of Medicine. The differences are mainly due to the basic approach to Health and Diseases; perception and also epistemological. The Ayurveda is holistic in approach, in diagnosis, prognosis as well as management' of diseases. Holistic approach of Ayurveda is indeed good and welcome in clinical practice (for the 'patient' and the 'society'). However, this approach has considerable difficulties and even challenges the scientists to devise parameters and design suitable models for clinical studies/trials. The pursuit of a better understanding of the facts and phenomena in Ayurveda and- Siddha, through scientific research will be able to fill this gap.

Only using the modem scientific tools without considering the holistic concepts of traditional medical system, may sometimes lead to inappropriate conclusions. This is high time to create the scientific evidences on Ayurvedic principles and practices taking into the consideration of basic principles and philosophies embodies in the literature and correlating them with the modem scientific concepts, which will rightly convey and translate the merits of Ayurveda and other traditional systems of medicine.

The Central Council for Research in Ayurveda and Siddha has been engaged in scientific research in Ayurveda and Siddha since more than past three decades and executing research adopting the integrative protocols. I appreciate the involvement of scholars from various reputed organizations like Indian Council of Medical Research, All India Institute of Medical Sciences, Lady Harding Medical College, NIMHANS, Bangalore and other institutes while drafting and finalizing the protocols.

The views and endorsement of experts from both Ayurveda and Allopathic systems enriched the protocols providing a good scope of integrative research for creating scientific evidence.

As research methodology is a continuously evolving subject, one should always consult the current updates and modify the protocols and formats as per the needs from time to time. This document would greatly serve as basic reference material for scientists and scholars who are involved in" clinical research in Ayurveda, Siddha and other traditional systems of medicine.

I appreciate the efforts of CCRAS in bringing out this document and would certainly receive 'a warm welcome from scientists and scholars engaged in traditional medicine research.

Preface Research is essential for development of any science. This is even more necessary in respect of ancient sciences like Ayurveda and Siddha. The various schemes and initiatives of Government of India led to- establishment of a National body "Central Council for Research in Indian Medicine and Homeopathy (CCRIMH) in 1969. The Central Council for Research in Ayurveda & Siddha was started in 1978 as a successor to CCRIMH, for research in Ayurveda and Siddha.

The Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry of Health & Family Welfare, and Government of India is an apex Nodal Body in India for the formulation of Research in Ayurveda and Siddha on scientific lines. The research activities of CCRAS include Literary Research, Drug Research, Clinical Research including Nutraceutical Research, Cosmeceutical Research and Bio-medical instrumentation and Reproductive and Child Health Care Research. The Council has been carrying out its research activities through the network of the peripheral institutes across the country and also in collaboration with various National and International academics and Research Organizations.

The Council is executing research studies on scientific lines as per the prevalent guidelines with Ayurveda and Siddha related part so as to make it integrative in nature. The Council has currently undertaken execution of clinical trials on more than 30 priority areas on phased manner adopting the current norms of drug development process viz. pre-clinical standardization/toxicity studies and phased clinical trials.

The integrative research protocols and Case Report Forms (CRFs) incorporating basic principles of Ayurveda and current requirement and methodology of research etc. have been developed from time to time through extensive consultative process involving high profile experts in the field of Ayurveda and Allopathic system of medicine from reputed institutes viz. AIIMS, ICMR, CSIR, NIMHANS and so on.

Dissemination of these methodologies by publishing the formats of selected diseases along with protocols, Case Report Forms (CRFs) would help the scientists, academicians, PG and Ph.D. scholars etc. who wish to conduct research on different diseases/conditions in developing protocols and serving as a basic reference material. However, the specific protocol could b developed by individuals suitable to their needs based on the specific objectives.

There has been a great need for a comprehensive compendium of Protocol formats an Case Report Forms (CRFs) for ready reference of research scholars, scientists etc. Keeping the in view the Council is publishing the present compendium and I am convinced that this will be ( immense help not only for researchers more so ever to the Post Graduate and Doctorial Scholars.

I am highly thankful to Dr. C. D. Tripathi, Professor & Head, Deptt. of Pharmacology: Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi for sparing his valuable time by offering suitable suggestions that has made this document more authentic and scientific.

I greatly appreciate the scientists of CCRAS, expert members of task force whose effort made this work possible. I also appreciate Dr. M.M. Sharma, Dr. B.S. Sharma, Mr. Upendra Singh & Mr. Narender Singh from publication section for their tireless efforts in bringing out this publication, Mr. Gaurav Kumar and Mr. Prasant Choudhary, Data Entry Operators for secretarial assistance.

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