An open-label, prospective, multicenter, clinical study to evaluate efficacy of Ayuartis capsules in patients suffering from osteoarthritis of the knee(s)

BACKGROUND: The management of chronic degenerative joint disorders such as osteoarthritis (OA) with ayurvedic medicines provides a safe and effective alternative. Ayurvedic medicines possess analgesic, anti-inflammatory, anti-oxidant and immunomodulator activities. AIMS: The main aim of the study was to assess the efficacy of Ayuartis capsule in patients suffering from OA of the knee(s). MATERIALS AND METHODS: Thirty-one patients suffering from OA knee(s) were recruited after evaluating them as per inclusion/exclusion criteria. Patients were advised to take two Ayuartis capsules twice daily orally for 90 days. Knee joint(s) pain was assessed on the Visual Analog Scale. Patients’ joint pain, stiffness, and physical functions were assessed on the Western Ontario McMaster University Osteoarthritis (WOMAC) index. Quality of life (QOL) and the time required to walk 50 feet was evaluated. Patients were called for follow-up visits on every 15(th) day till 90 days. Adverse events and vitals were recorded at every visit. Safety laboratory investigations were done before and after the completion of trial. STATISTICAL ANALYSIS: Data describing quantitative measures are expressed as mean ± standard deviation. The comparison of variables representing categorical data was performed using pair t-test. RESULTS: The mean joint pain reduced significantly by 53.82% on day 90. The mean WOMAC combined score, pain score, stiffness score and difficulty score reduced significantly by 50.88%, 54.96%, 58.76% and 49.02%, respectively on day 90. A significant improvement was observed in mean QOL of patients. A significant reduction in mean time required to walk 50 feet was observed. Majority of the patients had shown good overall improvement and excellent tolerability to the trial drug. CONCLUSION: Ayuartis capsule is a safe and effective medicine for the treatment of OA of the knee(s).