OBJECTIVE: To observe clinical efficacy and safety of Jiedu xiaoyu cream combined with Glucosamine potassium sulfate capsules in the treatment of knee osteoarthritis. METHODS: 196 patients with knee osteoarthritis were randomly divided into observation group and control group, with 98 cases. Both group were given Glucosamine potassium sulfate capsules 0.5 mg/time, bid; observation group additionally received Jiedu xiaoyu cream for local use, once a week; control group additionally received Diclofenac diethylamine emulsifiable paste for local use, bid. A treatment course lasted for 2 weeks, and both groups received 3 courses of treatment. Clinical efficacy, VAS scores, WOMAC scores and ADR of 2 groups were observed. RESULTS: The total effective rate of observation group was 94.7%, which was significantly higher than that of control group (88.3%), with statistical significance (P<0.05). Compared with before treatment, VAS and WOMAC scores of 2 groups decreased obviously, with statistical significance (P<0.05); the decrease of observation group was more significant than that of control group, with statistical significance (P<0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). CONCLUSIONS: Jiedu xiaoyu cream combined with Glucosamine potassium sulfate capsules has good clinical efficacy in the treatment of knee osteoarthritis, can relieve knee pain and improve the function of activity.