Abstract: AIM: To compare the efficacy and safety of the lizhi soft capsule and the qianliekang capsule in the treatment of patients with benign prostatic hyperplasia. METHODS: The lizhi soft capsule was observed in the randomized, double blind and double-dummy clinical trial.101 patients with benign prostatic hyperplasia were radomly divided into two groups:50 patients were administered the lizhi soft capsule (trail group), while 51 patients were administered the qianliekang capsule (control group).Drugs were orally administered with the same duration in the two groups.Scores of symptoms were recorded before and after the treatment in all of the patients. Curative effects were evaluated with the different grades such as conspicuous, remission, middle, weak and inefficacy.RESULTS: The scores of symptoms significantly decreased after the treatment in the two groups (P < 0.05).There was no significant difference in curative effects between two groups (P>0.05).No serious side effects were found in the two groups.CONCLUSION: Both the lizhi soft capsule and the qianliekang capsule have the same efficacy and safety in the treatment of benign prostatic hyperplasia.

Key words: clinical trial, the lizhi soft capsule, the qianliekang capsule, benign prostatic hyperplasia, traditional Chinese medicine