OBJECTIVE: To evaluate the clinical efficacy and safety of Rebixiao (RBX) Chinese herbal tablets (CHT) and Chinese formula granules (CFG) in the treatment of acute gout arthritis (AGA).METHODS: This randomized,multicenter,double-blind,controlled trial included 165 AGA patients with the damp-heat symptom pattern who were randomly divided into an RBX CHT group and an RBX CFG group and treated for 7 d at three centers.The total effective rates of the joint symptom score,Traditional Chinese Medicine (TCM) symptoms score,erythrocyte sedimentation rate (ESR),and C-reactive protein (CRP) were used to evaluate the clinical efficacy.Safety assessments were also performed.RESULTS: Of the 165 enrolled patients,147 completed the clinical observation.There was no difference in baseline between the two groups.The total effective rates of the joint symptom score were 94.36％ and 97.36％,and the total effective rates of the TCM symptoms score were 95.77％ and 97.36％ in the CFG group and CHT group,respectively.No statistical difference was found between the two groups (P ＞ 0.05).Additionally,ESR and CRP were similar in both groups (P ＞ 0.05).Furthermore,treatment efficacy regarding TCM and joint symptoms,the ESR,and CRP were consistent within each center and among the different centers (P ＞ 0.05).In addition,the incidence of adverse events was 4.22％ and 2.63％ in the CFG group and CHT group,respectively,and no difference was observed between the two groups (P ＞ 0.05).CONCLUSION: RBX CFG and CHT have significant and similar efficacy in the treatment of AGA,and CFG did not increase adverse side effects.