Objective To study the safety and effective of Zhongtong Aerosol in patients with closed and acute soft tissue injuries. Methods Using the method of Randomized， Double-blind and Placebo-controlled， the 36 subjects were randomly divided into drug group and placebo group. Assessments of therapeutic effect will be made at the （2±0.5）h， （24±2）h， （48±2）h， and （7±1）days by using NRS， PGIC and the Short Form-36（SF-36） to assess pain， swell and quality of daily life. Results At the （48±2）h， the primary efficacy indicators and most secondary efficacy indicators of drug group are better than that of placebo-controlled group. In terms of drug safety， no adverse events occurred. Conclusion The results show that Zhongtong Aerosol in patients with closed and acute soft tissue injuries is safe and effective.