To evaluate the safety and efficacy of Tongshu Capsules in the treatment of soft tissue injury caused by overuse.Methods:A double-blind，placebo-controlled method was used.According to whether Tongshu Capsule was used or not，the patients were divided into control group (n＝26) and observation group (n＝28).VAS，PGIC and SPID were used to evaluate the degree of pain relief at 72(±2) hours，7(±2) days，14 (±2) days，and 21(±2) days after the medication so as to evaluate the efficacy and safety.Results:The differences of VAS，PGIC and SPID between observation group and control group had statistical significance at 72(±2) hours，7 (±2) days，14 (±2) days，21(±2) days after the medication，and the differences of effective rate also had statistical significance at 7(±2) days，14 (±2) days，21(±2) days after the medication.In the aspect of safety，there appeared 2 cases of adverse reactions of stomach discomfort.Conclusion:It is safe and effective to use Tongshu Capsules in the treatment of soft tissue injury caused by overuse.