Under
the auspices of Government of India, Council of
Scientific & Industrial Research has launched
a scheme entitled “New Millennium Indian
Technology Leadership Initiative” (NMITLI)
that seeks to realize the vision of developed
India in Science and Technology. The scheme envisages
to support innovation centered scientific &
technological developments as a vehicle to attain
for the country a global leadership position at
least in some selected niche areas. Ayurveda is
one such niche area that needs to be developed
in the modern context of evidence based medicinal
system.
Wide-ranging
and widespread national consultations, followed
by stringent and rigorous system of screening,
expert evaluation and assessment has identified
‘Herbal based preparations for degenerative
metabolic disorders’ as one of the NMITLI
projects. Thereafter, through inputs from experts
in the area, a detailed project on ‘arthritis’
was evolved involving several national institutions
and pharma industries. This project will be completed
over a 4-year period beginning 2002.
The
primary focus in the NMITLI ARTHRITIS project
is to develop Ayurvedic herbal-based preparations
for treatment of OA, with special reference to
pain relief, better quality of life and chondroprotection.
The
research model envisages concurrent pharmacological
and clinical development to achieve quality-standardized
product, define mechanism of action, identify
active principles, document safety and demonstrate
clinically significant efficacy. The clinical
drug trial evaluations would begin along with
animal and other bench studies- a truly reverse
pharmacology paradigm fuelled by historical and
authoritative Ayurvedic knowledge of medicinal
use spanning thousands of years. However, clinical
and all other evaluations would be performed as
per state-of-the art protocols using modern medicine
science and concepts. Well designed and appropriately
powered scientific experiments and explorations,
and rigorous drug testing and
clinical
trials will steer the development and progress
step-wise to ultimately finalize the final formulation
of the herbal medicine for OA Knees. These herbal
formulations will be compared to the known modern
medicines in current use.
Core
set measures of efficacy of therapeutic interventions
in OA knees, that are globally accepted, will
be used. While preparing protocols and other related
documents, reference will be made to the guidelines
issued by the American College of Rheumatology,
US FDA, WHO and OMERACT
A
minor component of this project will also evaluate
some promising Ayurvedic medicines for treatment
of active RA. CRD Pune is the principle clinical
investigation & co-ordination center for this
project. Other clinical centers are AIIMS (Delhi),
KEM hospital (Mumbai), SPARK (Mumbai) and NIMS
(Hyderabad). Besides, CRD interacts with several
national facilities like RRL (Jammu), NIBR (Lucknow),
ARI (Pune), IRSHA (Pune), etc., to collate &
interpret data leading to validated standardized
Ayurvedic medicines for treatment of OA knees.