Abstract: OBJECTIVE To evaluate the clinical efficacy of Huang’e capsule on benign prostatic hyperplasia (BPH) with Qi-deficiency and Blood-stasis, Dampness-heat and blood-stasis syndrome. METHODS All of 148 patients who were diagnosed as BPH with Qi-deficiency and Blood-stasis, Dampness-heat and blood-stasis syndrome were randomly divided into treatment group and control group. Seventy-four patients in treatment group were treated with Huang’e capsule by 3 times daily, 4 capsules every time, while other 74 patients in control group were treated with placebo by 3 times daily, 4 capsules every time. IPSS scores, maximum urine flow rates and TCM syndromes of pre- and post- treatment were compared and analyzed. RESULTS The total effective rate of the treatment group was 85.14%, with 33.78% markedly effective and 51.36% effective. The total effective rate of the control group was 35.13%, 1.35% markedly effective and 33.78% effective. There was statistical significance for the superiority test between the treatment group and control group. Through superiority test, there were statistically significant differences between two groups in the end points for TCM syndrome score, I-PSS score and maximum urine flow rate improvement. No serious adverse events and adverse reactions were found in the trails. There was no significant difference between the two groups. CONCLUSION Huang’e capsule was safe and effective on BPH with Qi-deficiency and Blood-stasis, Dampness-heat and blood-stasis syndrome.