A double-blind, randomized, multicentric, placebo-controlled clinical trial of antarth, a phytomedicine, in the treatment of osteoarthritis

OBJECTIVE: To test Antarth, a polyherbal phytomedicine, for its efficacy and safety in patients with osteoarthritis (OA) and compared with placebo. MATERIAL AND METHODS: A total of 90 male or female adult patients who were diagnosed clinically and radiologically with OA were recruited in the study. Antarth or placebo was given 2 capsules b.i.d. for 3 months and the patients were assessed every month for its efficacy. Diclofenac sodium was allowed to be taken as rescue medication. RESULTS: After 3 months of treatment, the reduction in severity of pain on Visual Analog Scale (VAS) was more in Antarth group compared to placebo but the difference between the two groups was not significant. However, pain during functioning of disabled joints while walking distance, squatting, sitting cross-legged and climbing steps were significantly reduced in Antarth group compared to placebo (P < 0.05). Reduction in consumption of rescue medication, diclofenac sodium, was more in Antarth than in placebo group. CONCLUSIONS: In Patients’ Global Assessment, patients treated with Antarth were more satisfied than the ones treated with placebo. Observations were similar in Physicians’ Global Assessment too. There were no adverse events in both the groups.