title: A Randomized Controlled Exploratory Evaluation of Standardized Ayurvedic Formulations in Symptomatic Osteoarthritis Knees: A Government of India NMITLI Project.
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 (P < .05) for pain (weight bearing) and WOMAC questionnaire (knee function); placebo response was high. Based on better pain relief, significant (P < .05) 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.
authors.affiliation: Centre for Rheumatic Diseases (CRD), Hermes Elegance,1988 Convent Street, Camp, Pune 411001, India.
authors.forename: Arvind
authors.initials: A
authors.lastname: Chopra
authors.forename: Manjit
authors.initials: M
authors.lastname: Saluja
authors.forename: Girish
authors.initials: G
authors.lastname: Tillu
authors.forename: Anuradha
authors.initials: A
authors.lastname: Venugopalan
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Sarmukaddam
authors.forename: Ashwini Kumar
authors.initials: AK
authors.lastname: Raut
authors.forename: Lata
authors.initials: L
authors.lastname: Bichile
authors.forename: Gumdal
authors.initials: G
authors.lastname: Narsimulu
authors.forename: Rohini
authors.initials: R
authors.lastname: Handa
authors.forename: Bhushan
authors.initials: B
authors.lastname: Patwardhan