Abstract： Objective： To observe the clinical effect and safety of Shugan Yishen Tongyu Prescription combined with acupuncture method of soothing liver and tonifying kidney for delayed menstruation (liver depression and kidney deficiency type). Methods：A total of 98 cases of patients with delayed menstruation (liver depression and kidney deficiency type) were selected and divided into the control group and the observation group according to the random number table method， with 47 and 51 cases in each group respectively. The control group was given routine treatment of modern medicine (Estradiol Valerate Tablets，Dydrogesterone Tablets)，and the observation group was additionally treated with Shugan Yishen Tongyu Prescription combined with acupuncture method of soothing liver and tonifying kidney based on routine treatment. The clinical effects，ovulation rates and adverse reactions were compared between the two groups，and the changes in traditional Chinese medicine (TCM) syndrome scores，sex hormone levels [estradiol (E2)， luteinizing hormone (LH)， serum follicle stimulating hormone (FSH)] and endometrial thickness were compared before and after treatment between the two groups. Results：The total effective rate was 96.08% in the observation group and 82.98% in the control group，the difference being significant (P＜0.05). After treatment， the scores of TCM syndromes including irregular menstruation， scanty menstruation， distending pain in lower abdomen， and distending pain in breast in the two groups were decreased when compared with those before treatment (P＜0.05)，and the above scores in the observation group were lower than those in the control group (P＜0.05). After treatment，the ovulation rate was 72.34% in the control group and 92.16% in the observation group，the difference being significant (P＜0.05). After treatment，the levels of sex hormones including E2，LH and FSH in the two groups were increased when compared with those before treatment (P＜0.05)，and the above three levels in the observation group were higher than those in the control group (P＜0.05). After treatment，endometrial thickness in the two groups was increased when compared with that before treatment (P＜0.05)， and endometrial thickness in the observation group was higher than that in the control group (P＜0.05). There was no significant difference being found in the comparison of the incidence of adverse reactions between the two groups (P＞0.05). Conclusion：Shugan Yishen Tongyu Prescription combined with acupuncture method of soothing liver and tonifying kidney for delayed menstruation (liver depression and kidney deficiency type) has a significant clinical effect， which can improve symptoms and sex hormone levels， and increase ovulation rates with high safety.