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
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 views and endorsement of experts from both Ayurveda and Allopathic systems
enriched the protocols providing a good scope of integrative research for creating scientific
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.
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
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
Book's Contents and Sample Pages
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