Objective To prepare the Sanqi Gukangwang capsules and evaluate its clinical efficacy and safety for treatment of acute soft tissue injury dur to military training. Methods Traditional Chinese Medicine containing Panax notoginseng and Resina dragonis were used as main components, accompanied by other medicines. The quality control of the capsules was made. By the randomized,double-blind, placebo-controlled parallel method, 130 patients with military training caused injuries of acute soft tissue were randomly divided into Sanqi Gukangwang capsules treatment group and control group, both orally after meal,3 capsules/time, 3 times/d,15 d for a course of treatment, and to observe the clinical symptoms and signs of change before and after treatment. Results The total effective rate was 81.5% in the treatment group,55.4% in the control group, the effect in treatment group was better than in the control group (P＜0.05); and after treatment,the pain,tenderness,swelling points ,ecchymosis, dysfunction points significantly decreased compared with the control group (P＜0.05),daily living (ADL) total score improved than in the control group (P＜0.05). The patients had no adverse events before and after treatment. Conclusions Sanqi Gukangwang capsules have the scientific and reasonable technology, the stable quality; its treatment of military training caused acute soft tissue injury is effectives safe and reliable.