A prospective, open-label, non-randomised clinical trial to evaluate the safety and efficacy of Rymanyl Tablets in the treatment of Osteoarthritis

Abstract

Objectives: To evaluate the clinical efficacy and safety of Rymanyl Tablets in patients with knee osteoarthritis. Material and Methods: A prospective, interventional clinical study was conducted on 70 patients, aged between 18-60 years, confirmed with knee osteoarthritis and who were willing to give informed consent. All patients received Rymanyl Tablets at a dose of two tablets twice in a day for 90 days. All patients were evaluated at baseline and 90 days for improvement in knee flexion, quadriceps and hamstring muscle strength, 6-minute walk test score, European Q5D quality of life; reduction in knee swelling, pain intensity, WOMAC-pain, stiffness and physical function score and VAS pain scale. The Physician global assessment and Patient’s global assessment (at end of the study) on efficacy and tolerability were made on a scale of 1- 5, namely, Excellent = 5, Good = 4, Fair = 3, Poor = 2 and Very Poor = 1. Results: Rymanyl Tablets could significantly improve all outcomes including improvement in knee flexion, quadriceps and hamstring muscle strength, 6-minute walk test score and European Q5D quality of life; reduction in knee swelling, pain intensity, WOMAC-pain, stiffness and physical function score and VAS pain scale. Conclusion: Rymanyl Tablets typically improve knee flexion, quadriceps and hamstring muscle strength, walking capacity, overall physical function and quality of life as well as reduce knee swelling, intensity of pain and stiffness, assessed at baseline and 90 days. There were no clinically significant adverse events either reported or observed during the entire study period.