Abstract: AIM: To evaluate the efficacy and safety of the shexiang tongbi babu mastic (STBM) in treatment of patients with bony arthritis.METHODS: 240 trail subjects were involved in a multi-center randomized, signal-blinded, and positive drug parallel-controlled clinical trail (the trial group treated with STBM, and the control group treated with the tongluo qutong mastic).115 patients were enrolled in the trial group, and 113 cases enrolled in the control group.RESULTS: The total effective rate of the trial group was 88.70%, and better than that in the control group (79.65%) (P <0.05).Compare with the trial group, there was a significant decrease on the level of symptom score in the trial group (P < 0.01).The trial group improved the symptoms, such as the pains and uncomfortable feelings and arthritis pains (P <0.01).CONCLUSION: STBM is an effective and safe agent against bony arthritis.

Key words: the shexiang tongbi babu mastic, bony arthritis, deficiency of liver and kidney, stasis of the channels, TCD therapy, clinical trial