AbstractBackgroundStudies have demonstrated the association of hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease, and chronic renal disease. Although Western medicine presents promising effects for treating hyperuricemia and gout, identifying a safe and effective alternative to traditional Chinese medicine (TCM) for treating hyperuricemia is essential.ObjectiveTo evaluate the efficacy and safety of TCM formulas, “Wu‐Ling San” and “Yin Chen Wu‐Ling San,” in patients with hyperuricemia.MethodsA randomized, double‐blinded, placebo‐controlled clinical trial in adults with hyperuricemia was conducted. Sixty patients with serum urate level higher than 8 mg/dL were enrolled in the study. Patients were then randomized into three arms: “Wu‐Ling San,” “Yin Chen Wu‐Ling San,” and placebo for 4 weeks. Efficacy and safety were evaluated at weeks 2, 4, and 8. Primary and secondary endpoints were set to evaluate the serum urate concentration and related indicators at weeks 2, 4, and 8.ResultsNo significant differences were observed among the three arms in terms of the serum urate level (<6 mg/dL) at week 4. The serum urate level was lower in the “Yin Chen Wi‐Ling” arm at week 8 (8.1 mg/dL vs. 9.1 mg/dL, p = .034). The serum urate levels were significantly different in both the “Wu‐Ling San” and “Yin Chen Wu‐Ling San” arms from those at the baseline (p < .05).ConclusionsTwo TCM formulas were found to be relatively safe for the short‐term treatment of the patients with hyperuricemia. No statistically significant difference was observed in reaching the target–serum urate level <6 mg/dL.