A Randomized Double-blinded Placebo-controlled Study to Determine the Efficacy of Rhuleave-K on Subjects with Mild to Moderate Osteoarthritis

BACKGROUND: Osteoarthritis (OA) is a common degenerative joint disorder characterized by pain, stiffness, and reduced mobility, impacting the quality of life. Extracts from turmeric (Curcuma longa) and Boswellia (Boswellia serrata) have shown significant anti-inflammatory effects. Rhuleave-K has been formulated as a natural combination of turmeric extract, Boswellia extract in sesame oil using Speed Technology. PURPOSE: The present clinical investigation assessed the efficacy and safety profile of Rhuleave-K in comparison to a placebo, among subjects with mild-to-moderate osteoarthritis (OA). Materials and Methods This randomized, double-blind, placebo-controlled study enrolled 100 subjects with mild to moderate OA symptoms (Kellgren–Lawrence (KL) grade 2–3) and pain intensity >5 on the Numerical Rating Scale (NRS). Participants were administered either 500 mg of Rhuleave-K soft gel capsules (turmeric extract, Boswellia extract, and sesame oil as key components) as a test product or a matching placebo once daily for 12 weeks. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the end of the study. The secondary outcomes included Osteoarthritis Research Society International (OARSI) battery tests and NRS scores. Data were recorded at baseline and on day 5, week 6, and week 12. Safety assessments, including blood biochemistry and vital signs, were performed at baseline and week 6 and week 12. RESULTS: The test group showed a significant improvement in the total WOMAC score of 55% (p < .001), whereas there was a negligible change (0.72%) in the placebo group. The WOMAC pain reduction was 75% (p < .001), WOMAC stiffness was 67% (p < .001), and WOMAC functional limitation was 48% (p < .001) from baseline. There were significant improvements in the OARSI battery of tests, such as the 40 m fast-paced walk by 10%, nine-step stair negotiation (9SSN) by 1%, 30 s chair stand test by 34%, timed up and go test by 18%, and 6 min walk test by 8% from baseline. The range of motion, as measured by goniometry, showed significant improvement (mean difference 2.06° ± 1.24°, p < .001) in flexion, whereas there was no change in the placebo group. C-reactive protein (CRP) showed a clinically significant 77% decrease, and complete blood count (CBC), liver function test (LFT), and renal function test (RFT) showed statistical significance, but no clinically significant changes, and no adverse events were evident in either the test or the placebo group during the study period. The treatments were well tolerated in the present study. CONCLUSION: Rhuleave-K, at a daily dose of 500 mg for 12 weeks, significantly decreased pain, joint stiffness, difficulty in physical function, and mobility associated with mild-to-moderate OA compared with placebo. The improvement was observed as early as 6 weeks and can be a safe and suitable addition to the current management of OA.