A prospective, multicenter, interventional, phase IV clinical trial to evaluate the efficacy and safety of Pravek Rumakalp® tablets for the treatment of musculoskeletal pain and inflammation

Introduction: Musculoskeletal disorders (MSD), affecting over 1.7 billion people globally, are a leading cause of disability. These conditions, including osteoarthritis, rheumatoid arthritis, back pain, and soft tissue injuries, can severely impact quality of life, work productivity, and healthcare costs. While traditional NSAIDs provide pain relief, concerns over side effects have increased the demand for alternative treatments. Pravek Rumakalp®, an Ayurvedic non-steroidal formulation, is designed to alleviate musculoskeletal pain and inflammation, and this study evaluates its efficacy and safety.Methods: This phase IV, multicenter, prospective, interventional trial enrolled 100 patients with musculoskeletal pain and inflammation. Participants received Pravek Rumakalp® tablets for 90 days, with a final telephonic follow-up on Day 97. The efficacy was assessed using the Pain Intensity Numeric Rating Scale (PI-NRS) and the Clinical Global Impression (CGI) scale. Safety was evaluated by monitoring adverse events (AEs), vital signs, laboratory tests and ECGs. Statistical analysis was performed using repeated measures ANOVA.Results: Significant reductions in PI-NRS scores were observed at each follow-up visit (Day 30, Day 60, Day 90), with p-values