Abstract: AIM: To evaluate the efficiency and safety of the shukemian capsule (SC) in treatment of patients with asomnia (liver-spirit blocked). METHODS: The double-dummy and randomized controlled method was adapted to assess 440 patients (liver-spirit blocked) who were divided into the treatment group (n=330, treated with SC 4 capsules, twice a day after supper and before sleeping) and the control group (n=110, treated with shumian capsule 3 capsules, twice a day after supper and before sleeping).The duration of treatment for both groups was 2 weeks. RESULTS: After 2 weeks, the rate of recover and effectiveness in control group was 40.0 % (n=110), and that in treatment group was 58.0 %(n=329) which was higher than that in treatment group (P < 0.01).No side effect was found in this clinical study. CONCLUSION: Shukemian capsule is a safe and effective agent in treating asomnia (liver-spirit blocked).

Key words: shukemian capsule, asomnia (liverspirit blocked), clinical trial