Efficacy of GV22202 in subjects with mild knee osteoarthritis: A randomized, triple arm trial assessing pain reduction and functional outcomes

BACKGROUND: GV22202, a highly bioavailable extract of Curcuma longa rhizomes, was evaluated for safety and efficacy in improving knee osteoarthritis (OA) symptoms in a randomized, double-blind, placebo-and active comparator-controlled parallel-group clinical trial (CTRI/2023/04/051793). METHODS: One hundred and fifty subjects were equally randomized to: placebo, GV22202-200 mg, and active comparator-1000 mg arms and supplemented for 84 days. Primary efficacy was assessed by changes in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index scores, with secondary measures including Visual Analogue Scale (VAS) pain ratings, Lequesne's Functional Index (LFI), Six-Minute Walk Test (SMWT), Stair Climb Test (SCT), and Isometric Knee Torque. RESULTS: GV22202 demonstrated improvements across all WOMAC subdomains (pain, stiffness, and physical function) starting at day 6, with sustained benefits through day 84. By day 84, the average total WOMAC score was decreased by 23.2%, with reductions of 16.02 ± 3.90 for pain, 14.38 ± 6.09 for stiffness, and 10.68 ± 3.14 for physical function. GV22202 outperformed the active comparator by 8.9% in total WOMAC score. In addition, participants in GV22202 showed substantial (p < 0.0001) improvements in scores of VAS (25.6%), LFI (39.7%), SMWT (9.6%) and SCT (14.5%) than active comparator group. Biomarker analysis revealed superiority of GV22202 in reducing hs-CRP, TNF-α, IL-6, MMP-3, uCTX-II and increasing TAC compared to active comparator. CONCLUSION: GV22202 was well tolerated and demonstrated superior efficacy in alleviating knee osteoarthritis symptoms, improving functional mobility, and enhancing overall joint health, which may be due to its anti-inflammatory, antioxidant, and chondroprotective potential.