OBJECTIVE: To observe the curative effect of Huqian Wan on liver and kidney-Yin deficiency knee osteoarthritis(KOA).METHODS: One hundred patients were randomly divided into a treatment(50 patients) and control group(50 patients). In the treatment group, patients orally took the Chinese medicine Huqian Wan. Control group patients orally took Votalin, 75 mg, once a day, for 8 weeks. The visual analog scale(VAS), Western Ontario and Mc Master University Osteoarthritis Index(WOMAC), and Medical Outcomes Study Short Form 36-Item Health Survey(SF36) were used to evaluate the curative effect before treatment and after 8 and 16 weeks of treatment.RESULTS: VAS and WOMAC scores significantly decreased and SF 36 scores significantly increased after treatment in both groups compared with before treatment(P < 0.05). There were significant differences in VAS, WOMAC, and SF 36 score changes between the two groups at week 16(P < 0.05).There was a significant increase in VAS and WOMAC scores in the control groups(P < 0.05) between weeks 8 and 16, but no significant difference was found in the treatment group(P > 0.05).CONCLUSION: Huqian Wan could effectively improve the clinical symptoms and quality of life in patients with KOA. It could also have a better and longer lasting curative effect without obvious adverse events compared with Votalin.