Abstract: OBJECTIVE To observe the therapeutic effect and safety of Tongsaimai Tablet in treating knee osteoarthritis (OA) of qi-yin deficiency type. METHODS 100 patients with knee osteoarthritis of qi-yin deficiency type were divided into treatment group equally assigned，according to randomizing number table，to the treatment group (50 cases) treated with Tongsaimai Tablet and the control group (50 cases) treated with glucosamine hydrochloride by random number table method. The indexes， which reflecting the degree of joint pain and walk capacity，pain and difficulty in up and down stairs， buckling angle and degree of stiffness， contracture， and swell， the improvement of patients symptoms and the integral estimation in patients， were measured and recorded before and after treatment. Moreover， blood， urinary and feces routine tests，liver and kidney function examination，and the adverse reaction that occurred in the treatment period were observed. RESULTS Indexes mentioned above in both groups before and after treatment showed significant statistical differences (P<0.05). Indexes in treatment group was more significant than that of the control group. No abnormal result was found， urinary and feces routine tests，liver and kidney function examination. CONCLUSION Tongsaimai Tablet is a safe and effective drug for the treatment of knee osteoarthritis，which could alleviate the joint pain，stiffness，dysfunction and swell.