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Evidence-Based Complementary and Alternative Medicine
Volume 2011 (2011), Article ID 724291, 12 pages
http://dx.doi.org/10.1155/2011/724291
Research Article

A Randomized Controlled Exploratory Evaluation of Standardized Ayurvedic Formulations in Symptomatic Osteoarthritis Knees: A Government of India NMITLI Project

1Centre for Rheumatic Diseases (CRD), Hermes Elegance,1988 Convent Street, Camp, Pune 411001, India
2Interdisciplinary School of Health Sciences (SHS), University of Pune, Pune 411007, India
3Rheumatology Departement, KEM Hospital and GS Medical College and SPARC, Parel, Mumbai 400012, India
4Rheumatology Departement, Nizam Institute of Medical Sciences (NIMS), Panjagutta, Hyderabad 500082, India
5Rheumatology Departement, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi 110029, India

Received 16 November 2009; Revised 22 March 2010; Accepted 15 August 2010

Copyright © 2011 Arvind Chopra et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The multidisciplinary “New Millennium Indian Technology Leadership Initiative” Arthritis Project was undertaken to validate Ayurvedic medicines. Herbal formulations in popular use were selected by expert consensus and standardized using modern tools. Our clinical strategy evolved from simple exploratory evaluations to better powered statistically designed drug trials. The results of the first drug trial are presented here. Five oral formulations (coded A, B, C, D and E), with a common base of Zingiber officinale and Tinospora cordifolia with a maximum of four plant extracts, were evaluated; with placebo and glucosamine as controls. 245 patients suffering from symptomatic OA knees were randomized into seven arms (35 patients per arm) of a double blind, parallel efficacy, multicentric trial of sixteen weeks duration. The groups matched well at baseline. There were no differences for patient withdrawals (17.5%) or adverse events (AE) of mild nature. Intention-to-treat efficacy analysis, demonstrated no significant differences ( ) for pain (weight bearing) and WOMAC questionnaire (knee function); placebo response was high. Based on better pain relief, significant ( ) least analgesic consumption and improved knee status, “C” formulation was selected for further development. Controlled exploratory drug trials with multiple treatment arms may be used to economically evaluate several candidate standardized formulations.