To observe the efficacy of Zishen Yutai pill combined with progesterone in the treatment of threatened abortion with luteal insufficiency.Methods:Seventy patients with threatened abortion with luteal insufficiency admitted to the Qingdao Central Hospital Affiliated to Qingdao University from October 2021 to January 2019 were selected and randomly divided into a control group(n=34) and a treatment group(n=36).The control group was treated with progesterone capsules，and the treatment group was additionally given Zishen Yutai pill based on the treatment of the control group.The clinical efficacy，disappearance time of lumbar and abdominal pain，time of vaginal hemostasis，success rate of fetal preservation，levels of serum estradiol(E2)，progesterone(P)，and human chorionic gonadotropin(HCG)，traditional Chinese medicine(TCM) syndrome score，pain score，and adverse reactions were compared between the two groups.Results:After treatment，the effective rate of the treatment group(8696%) was higher than that of the control group(6818%).The time of vaginal hemostasis and the time of lumbar and abdominal pain disappeared in the treatment group were shorter than those in the control group，and the success rate of fetal preservation was higher than that in the control group(P<005).Before treatment，there were no significant differences in TCM syndrome score，pain score，and levels of serum E2，P，and HCG between the two groups(P>005).After treatment，the levels of serum E2，P，and HCG in the two groups were increased，and those in the treatment group were higher than those in the control group.The TCM syndrome score and pain score in the treatment group were lower than those in the control group(P<005).There was no significant difference in adverse reactions between the two groups(P>005).Conclusion:ZishenYutai pill combined with progesterone has an ideal clinical effect on the treatment of threatened abortion with luteal insufficiency，which effectively improves the level of sex hormones，relieves clinical symptoms，and improves pregnancy outcome with high safety.