Efficacy and safety of Amrith Noni Arthoplus in osteoarthritis: a double-blinded, randomized clinical trial

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder marked by pain, inflammation, and impaired mobility, significantly affecting quality of life. Current treatments often provide limited relief and may have adverse effects with long-term use. This study aimed to evaluate the efficacy and safety of Amrith Noni Arthoplus in individuals with OA through a double-blinded, randomized clinical trial. Methods: This double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of Amrith Noni Arthoplus, an herbal formulation containing Morinda citrifolia (Noni) as the primary ingredient, in 40 patients with osteoarthritis (OA). Efficacy was evaluated using the visual analog scale (VAS) for pain intensity, 6-minute walk test, stair climb test, physician and subject global assessments (PGA/SGA), serum biomarkers (hs-CRP, calcium, phosphorus, magnesium, vitamin D3), and bone mineral density (BMD) via DEXA scans. Safety was assessed through vital signs, haematology, liver and kidney function tests, and adverse event monitoring. Results: The active group demonstrated significant improvements in pain intensity (33.82% reduction in VAS scores, p<0.0001), physical function (14.17% increase in walking distance, p<0.0001), and stair climb time (12.75% reduction, p<0.0001) compared to the placebo group. Serum biomarkers, including hs-CRP (31.33% reduction, p<0.0001) and bone health markers (calcium, phosphorus, magnesium, vitamin D3), showed significant improvements. BMD increased by 25.48% in the active group (p<0.0001), while the placebo group experienced an 18.10% decline (p=0.002). No adverse events were reported, and all safety parameters remained within normal limits. Conclusions: Amrith Noni Arthoplus significantly alleviates OA symptoms, improves physical function, and enhances bone health, demonstrating its potential as a safe and effective complementary therapy for OA management.