Efficacy and safety of Qinwei Oral Granules for acute gouty arthritis: A multicenter, randomized, double-blind, placebo-controlled phase III trial

Background Traditional Chinese Medicine formulations such as Qinwei Oral Granules (QWG) have shown analgesic and anti-inflammatory effects in gout; however, high-quality placebo-controlled evidence remains limited. Methods In this phase III, multicenter, randomized, double-blind, placebo-controlled trial, 476 patients with acute gouty arthritis from 12 hospitals in China were randomized (3:1) to receive QWG (12 g granules dissolved in water, three times daily; GMP-manufactured, quality controlled by HPLC fingerprinting) or matching placebo for 7 days. The primary endpoint was pain resolution, defined as a VAS pain score ≤10 mm sustained for ≥48 h without rescue medication. Results In the Full Analysis Set, pain resolution at 168 h was achieved in 60.7% (n = 359) of QWG vs 33.9% (n = 115) of placebo (risk ratio 2.10; 95% CI 1.48–2.98; P < 0.001). Median time to resolution exceeded 168 h in placebo, confirming superiority of QWG (log-rank P < 0.001). Secondary endpoints, including reductions in C-reactive protein (10.987 (18.003) vs −13.346 (18.366) mg/L; P < 0.001) and erythrocyte sedimentation rate (16.94 (49.67) vs −17.32 (20.76) mm/h; P < 0.001), were all significantly improved in the QWG group. Findings were consistent in the Per-Protocol Set. Adverse events occurred in 33.15% of QWG vs 29.81% of placebo, mainly mild gastrointestinal discomfort; no serious adverse reactions were reported. Conclusions QWG significantly accelerated pain resolution and reduced systemic inflammation compared with placebo, with a favorable safety profile. These findings support QWG as a potential therapeutic option for acute gouty arthritis. Trial Registration: ChiCTR2400083191 (Chinese Clinical Trial Registry).