Background and Objective: Gout, a metabolic disorder characterized by hyperuricemia and joint inflammation, is a growing global health concern. This study aimed to evaluate the efficacy and safety of Amrith Noni Artho Plus, an Ayurvedic formulation, in managing gout flare. Study Design: This was a double-blind, randomized, placebo-controlled clinical study conducted over 24 weeks. Forty participants with gout flare were randomized into two groups: the test group received Amrith Noni Artho Plus, while the placebo group received a matched placebo. Methods: Participants were selected based on inclusion and exclusion criteria. The study was conducted in compliance with the Declaration of Helsinki and ICH-GCP guidelines. Efficacy was assessed through changes in pain intensity (Visual Analogue Scale, VAS), serum uric acid levels, high-sensitivity C-reactive protein (hs-CRP), health assessment questionnaire (HAQ) score, and health-related quality of life (HRQOL, SF-36 questionnaire). Safety was evaluated through adverse events and laboratory parameters. Data were analyzed using descriptive statistics, t-tests, and ANCOVA. Results: The test group showed significant reductions in pain intensity (-41.50%, p < 0.0001), hs-CRP (-28.40%, p < 0.0001), and serum uric acid levels (-27.89%, p < 0.0001) compared to the placebo group. HAQ scores improved significantly in the test group (-30.41%, p < 0.0001), indicating better functional ability. HRQOL scores improved significantly in the test group across all domains (p < 0.0001). No adverse events were reported, and all safety parameters remained within normal ranges. Conclusion: Amrith Noni Artho Plus is an effective and safe intervention for managing gout flare, offering significant improvements in pain, inflammation, uric acid levels, and quality of life. Its favourable safety profile makes it a promising alternative to conventional gout treatments. Key words: Gout flare, Amrith Noni Artho Plus, Randomized Clinical Study, hyperuricemia, anti-inflammatory.
Umeshgiri et al. (Mon,) studied this question.