Background: Osteoarthritis is the most common degenerative joint disease. This study has focus on osteoarthritis (OA) of knees which primarily affects the elderly causing functional impairment and disability. There are no interventions that can completely reverse the disease progression by restoring degraded cartilage; however, symptoms can usually be effectively managed with lifestyle changes, physical and other therapies, medications, and surgery. Further, the existing studies have evaluated benefit of single herb or its essential oil towards treatment of OA pain or a symptom.
Objective: The proposed polyherbal oil (referred as test product) is a unique synergistic oil blend prepared using novel concept of Ayurveda Plant Nanocellopathy, as elaborated in the Sarangdhar Samhita, that blends therapeutic plant extracts/ oils to derive maximum benefit from the herb extracts/ oils having soothing, analgesics and anti-inflammatory properties. The objective of this study is to validate the efficacy of the topical use of the test product in treatment and control, and stopping or delaying progression of knee OA in comparison with the placebo.
Method: A randomized, double blind, parallel group, placebo controlled comparative study with 200 adult participants having OA of the knee was conducted. The participants who fulfilled the inclusion criteria were allocated between two study arms (test and placebo) in the ratio of 1:1 using randomization. The efficacy of the test product was measured as a decrease or negative change in VAS as well as WOMAC Index scores. Progression of OA, or regression of it was assessed radiographically by comparing the post and pre-treatment X-rays measured on K & L grade and joint space narrowing results. The safety of the test product was assessed in terms of adverse events, if any.
Findings: The decrease in the WOMAC Index score and VAS-POM score in test group was observed on a continuous basis, that is, from baseline to day 30 and then decreasing in subsequent follow-up visits on day 60 and day 90, suggesting that continuous use of the test product was beneficial to provide relief from symptoms. Significantly fewer participants with K & L grade >1 using test product showed progression in OA as compared to the placebo group. The test product did not result in any adverse events indicating safety of the oil use.
Conclusion: Topical application of test product is found effective in relieving the symptoms of knee OA and stopping progression of knee OA without any reported side-effects.