Objective:To evaluate the efficacy and safety of Shen Bao tablet in the treatment of benign prostatic hyperplasia with kidney yang deficiency. Methods:The 288 patients with benign prostatic hyperplasia with kidney yang deficiency were randomly divided into observation group and control group.216 cases of observation group were treated with Shenbao tablet and Yougui Pill simulant for 12 wk.72 cases of control group were treated with Shenbao tablet simulant and Yougui Pill for 12 wk. Before treatment, 4 wk, 8 wk and 12 wk after treatment, observe the effective of TCM syndrome, single score of TCM syndrome, total score of International Prostate Symptom and quality of life score of the two groups were observed Results:After 12 wk of treatment, 277 cases of the experiment were completed, 11 cases were shed (7 cases in observation group, 4 cases in control group, with a rate of 3.24%). The improvement of TCM symptoms in both groups was good, the total effective rate of the observation group was 95.83%, and that of the control group was 88.89%, the difference was statistically significant (P<0.05).2 cases of adverse events occurred during the trial, including 1 case of upper respiratory tract infection (0.46%) in observation group and 1 case of mild liver function abnormality (1.39%) in control group. Conclusion:Shenbao tablet is safe and effective in the treatment of the syndrome of benign prostatic hyperplasia with kidney yang deficiency, and the curative effect is better than Yougui Pill.