Objective To explore the clinical effects of Qilin Pills（麒麟丸） on irregular menstruation with the kidney and spleen deficiency syndrome and insufficient thoroughfare channel blood syndrome and its effects on ovarian reserve. Methods A total of 120 patients in 10 centers were included. The stratified block method was used to randomly divide them into a treatment group of 60 cases and a control group of 60 cases. The treatment group was given Qilin Pills

and the control group was given Tiaojing Cuyun Pills（调经促孕丸）. Patients in both groups were orally taken blinded packaged drugs twice a day

6 g each time

for a total of 3 menstrual cycles. The clinical efficacy of both groups was observed

and the levels and differences of anti-mullerian hormone（AMH）

basic follicle stimulating hormone（FSH）

basic estradiol（E

2

） and ovarian follicles（AFC） were compared before and after treatment between groups. The safety was evaluated. Results There was no significant difference in the total clinical effective rates between groups at visit 2

visit 3

visit 4

and visit 5（P

>

0.05）

and the effects were similar in the 2 groups. In the treatment group

under the condition of baseline AMH

<

1.4 ng/ml

the value of AMH after treatment was higher than that before treatment（P

<

0.05）. Besides

the change rate of AMH in the treatment group was greater than that in the control group [95%CI（-156.72

-0.26）]. There was no significant differences in AFC

FSH and E

2

levels and change rate（P

>

0.05）. There was no serious adverse reactions in both groups during the treatment. Conclusion Qilin Pills and Tiaojing Cuyun Pills may significantly improve the ovarian reserve function and menstrual condition

with good safety.