Draft White Paper

Pluralistic trends evident from health seeking behavior

It would not be an overstatement to say that the 21st Century will be the era of pluralism in Health Care. The human population, the world over, is grappling with new age health problems and not getting viable solutions for all their needs in any one single medical system. Therefore the growing acceptance of complementary systems of health care, which is evident in the recent health seeking behaviour studies…

Nature of evidence inherent in the Ayurveda knowledge system

It is necessary to point out that Ayurveda is an evidence based health science (pramana shastra) within its own knowledge domain. The knowledge contained in Ayurvedic texts is not hypothetical. It is based on hard clinical and pharmacological evidence based on Ayurvedic parameters. All the core fields of knowledge in Ayurveda like Dravyaguna Shastra (Pharmacology), Bhaisaj Kalpana (Pharmaceutics), Nidan (Diagnosis) and Chikitsa (Management principles) contain validated knowledge.

Need for trans-disciplinary evidence

Generating trans-disciplinary evidence is essential to facilitate communication, cooperation and collaboration between Ayurveda and biomedical sciences. This is a new and complex task because it requires assimilation of the disciplinary knowledge of Ayurveda (which is a systemic theory) and its translation and correlation with western bio-medicine (which is a structural theory). The correlation between two knowledge systems can certainly be discovered because biological fields and structures contained therein are related, but the key is to appreciate that systemic and structural parameters do not share a one to one correlation.

Justification of the whole systems approach to generate trans-disciplinary clinical evidence on Ayurveda

The challenge in designing clinical trials will be to develop designs that take into onsideration the multiple facets of Traditional Health Care intervention. The multiple facets of Ayurvedic

Management of health and disease are:
a.Customised intervention that varies according to individual constitution (prakriti) and the stage and intensity of disease.
b.Multi-component intervention involving drug, diet, lifestyle, pancha-karma and yoga.
c.A treatment approach that has homeostasis or restoration of physiological balance as its end point.

Outline of clinical design of the whole systems approach

In order to combine the knowledge systems of Ayurveda and adapt the existing statistical approaches to design and analyze the data, we will have to address the following issues:

1. How do you select eligible subjects for Ayurveda trials? Do you need to stratify all trials by the type of dosha?

2. How do you select the appropriate comparator group? Do you want to compare to a Placebo? How do you design a placebo which can be blinded? If this cannot be done, then how can we avoid a bias in interpreting the results? Do you want to use the existing/approved western bio-medicine as a comparator?

3. How do you define a quantifiable/objective end-point? Is there a systematic approach to turning a holistic, Ayurveda based, clinical end-point into an objective and quantifiable endpoint?

4. Are the Ayurvedic treatments that are being tested quantifiable? If not, can the different treatment levels be put on an ordinal scale?

Overview of the designs of clinical studies in Ayurveda undertaken in the past four decades, identifying issues that needs to be addressed through the current initiative.

This is will be based on a survey carried out by white paper team.