Objective: To observe the clinical efficacy of “Gengnian Ningxin Granules” in treating perimenopausal syndrome. Methods Sixty cases with perimenopausal syndrome were randomized into treatment group and control group, with 30 cases in each group. Treatment group was treated with “Gengnian Ningxin Granules”, and the control group was treated with placebo, with the course of 2 months. The modified Kupperman index, hot flashes times and levels of sex hormones (FSH, LH, E,2,) were observed.  Results: ① Non-shedding case during the period of the clinical trial. All the 60 cases completed the study. ② In both groups, there was significant difference in KI score between before and after the treatment (P＜0.05); after treatment, there was significant difference in KI score between the two groups (P＜0.05). ③ In both groups, there was significant difference in hot flashes times between before and after the treatment (P＜0.05); after treatment, there was significant difference between the two groups (P＜0.05). ④ In both groups, no significant difference was found in the levels of sex hormones (E,2, FSH, LH) between before and after the treatment (P＞0.05); after treatment, no significant difference was found in the levels of E,2, FSH and LH between the two groups (P＞0.05).  Conclusion: “Gengnian Ningxin Granules” is effective to improve the clinical symptoms in patients with perimenopausal syndrome. Its mechanism may be not association with the improvement of estrogen level.