Abstract: Objective: To observe the clinical effect of Tiaojing Cuyun Pills combined with western medicine in the treatment of premature ovarian insufficiency (POI) with kidney yang deficiency syndrome. Methods:A total of 120 POI patients with kidney yang deficiency syndrome were randomly divided into the control group and the treatment group, with 60 cases in each group, using a random number table method. The control group was treated with Estradiol Valerate Tablets and Progesterone Capsules,and the treatment group was treated with Tiaojing Cuyun Pills in addition to the treatment of the control group. The two groups were treated for a total of three menstrual cycles. Compared the menstrual symptom scores, traditional Chinese medicine (TCM) syndrome scores, sex hormone levels, and ovarian ultrasound examination indicators between the two groups before and after treatment, and evaluated the clinical efficacy and incidence of adverse reactions between the two groups. Results:The total effective rate was 91.67% in the treatment group,which was higher than that of 76.67% in the control group (P<0.05). After treatment,the menstrual symptom scores,TCM syndrome scores,ovarian artery resistance index (RI), serum follicle stimulating hormone (FSH), and luteinizing hormone (LH) levels in both groups were decreased when compared with those before treatment (P<0.05),and the peak systolic flow velocity (PSV) of ovarian artery blood flow,serum estradiol (E2),and anti Mullerian hormone (AMH) levels were increased (P<0.05), and the numbers of sinus follicles were increased (P<0.05); the menstrual symptom score, TCM syndrome score,RI,and serum FSH and LH levels in the treatment group were lower than those in the control group (P<0.05), E2, AMH, and PSV levels were higher than those in the control group (P< 0.05), and the number of antral follicles was more than that in the control group (P<0.05). During the treatment period, the incidence of adverse reactions was 3.33% in the control group, and 5.00% in the treatment group, there being no significant difference between the two groups (P>0.05). Conclusion: Tiaojing Cuyun Pills combined with western medicine has a definite therapeutic effect on POI with kidney yang deficiency syndrome, which can regulate the patient's sex hormone levels, improve ovarian blood supply,and is relatively safe.