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.

Oral herbal therapies for treating osteoarthritis

“…A further seven studies compared herbal interventions to both active and placebo controls in three (or more) arm designs (Adegbehingbe 2008; Bernhardt 1991; Biegert 2004; Bliddal 2000; Chopra 2011; Piscoya 2001; Teekachunhatean 2004). One study included a non-intervention control in a third arm comparison against a herbal intervention and placebo (Badria 2002).…”

“…All studies including active controls used a non-inferiority design, however in five of these studies we queried the activity of the comparator agent (Cao 2005; Chopra 2011; Chopra 2013;Mehta 2007; Pavelka 2010). …”

Nutraceuticals in the management of diabetes mellitus

“…55 By virtue of richness in essential phytonutrients, ayurvedic herbs may help as "Potentiators" for these drugs and play a supportive role to maintain the quality of the diabetic life. 56,57 There is vast potential of selected medicinal plants from Ayurveda and Indian folk role medicine. Several works have been attempted by CSIR, ICMR, DBT, and academia on role of herbal nutraceuticals, nutritionals and naturals in metabolic disorders like diabetes (Table 1).…”

Reverse Pharmacology Effectuated by Studies of Ayurvedic Products for Arthritis

“…It was also selected to study its potential as a herbal product, inspired from Ayurveda, compared to glucosamine in arthritis. The selection was based on literature search as well as consensus of experts 13 .…”