Objective To observe the efficacy and safety of Jingu Tongxiao Granules for knee joint osteoarthritis. Methods The patients were equally randomized into experimental and control groups with Jingu Tongxiao Pills used as the medicine for control. The clinical trial of double-blind double-imitation was adopted to observe the safety and efficacy indices of symptoms

signs and X-ray examination of knee joint. Results The total effective rate

controlled-markedly effective rate

total score of pathological condition before and after treatment between two groups

total effective rate of therapeutic effect of TCM syndromes of two groups

controlled-markedly effective rate

total effective rate of rest pain of the main symptoms and signs

tenderness of knee joint

morning stiffness and motor impairment of two groups

and changes of X-ray examination of two groups before and after treatment were not significantly different （P>0.05）. Conclusion Jingu Tongxiao Granules could effectively relieve the pain

morning stiffness and motor impairment of knee joint osteoarthritis safely. Compared with the original form

the efficacy and safety of Jingu Tongxiao Granules were the same.