To observe the clinical effects of Zishen Yutai Pill combined with progesterone injection in the treatment of threatened abortion.Methods:A total of 60 cases of 4 to 9 gestational weeks of threatened abortion patients in our hospital were randomly divided into treatment group and control group，with 30 cases in each.The control group was given daily intramuscular injection of progesterone injection 40 mg.The treatment group was given the Chinese herbal medicine Zishen Yutai pill on the basis of the control group.Two groups were 7 days for a course of treatment，with a total of 3 courses.The levels of serum chorionic gonadotropin (β-HCG)，progesterone (P) and estradiol (E2) were measured before and after treatment for 1，2 and 3 weeks.TCM syndromes before and after treatment were compared.The clinical efficacy of different age，gestational age and spontaneous abortion in the treatment group was compared with that in the treatment group.Results:The comprehensive effect of the treatment group and the control group was 90% and 77% respectively.The therapeutic effect of the treatment group was significantly higher than that of the control group (P<0.05).The levels of β-HCG，P and E2 in the serum of the two groups were significantly higher than those before treatment (P<0.01).The subjects in the two groups were significantly higher than those in the control group (P<0.01).The levels of serum β-HCG and E2 were not significantly different between the two groups (P>0.05).After 1，2 and 3 weeks of treatment，the levels of progesterone (P) increased significantly (P<0.01).There was no significant difference in the total effective rate of the subjects with different age groups，gestational age and spontaneous abortion in the treatment group (P>0.05).Conclusion:The clinical curative effect of Zishen Yutai Pill combined with progesterone injection on the treatment of threatened abortion is not significantly correlated with the age，gestational age and spontaneous abortion of pregnant women.The improvement of TCM symptoms is very significant，and the levels of P were significantly increased.