Abstract： Objective： To observe the clinical effect of the therapy of Modified Huangqi Shoutai Pills combined with Dydrogesterone on threatened abortion of spleen- kidney qi deficiency type. Methods： A total of 62 patients with threatened abortion of spleen- kidney qi deficiency were divided into the control group and the treatment group according to random number table method，with 31 cases in each group. The control group was given Dydrogesterone Tablets for treatment， and the treatment group was additionally treated with Modified Huangqi Shoutai Pills based on the treatment of the control group. Before and after treatment， the traditional Chinese medicine (TCM) syndrome scores， and levels of serum progesterone (P)，β-human chorionic gonadotropin (β-HCG) and estradiol (E2) were compared between the two groups，the clinical effects and incidence of adverse reactions in both groups were evaluated. Results： The total effective rate was 67.74% in the control group，lower than that of 90.32% in the treatment group (P＜0.05). After treatment，the levels of serum P，β-HCG and E2 in the two groups were increased when compared with those before treatment (P＜0.05)， and the TCM syndrome scores were decreased (P＜ 0.05)；the levels of serum P，β-HCG and E2 in the treatment group were higher than those in the control group (P＜0.05)，and the TCM syndrome score was lower than that in the control group (P＜0.05). There was no significant difference being found in the comparison of incidence of adverse reactions between the two groups (P＞0.05). Conclusion： The therapy of Modified Huangqi Shoutai Pills combined with Dydrogesterone has a definite curative effect on threatened abortion of spleen- kidney qi deficiency type， which can effectively increase the levels of endocrine hormones of patients with good safety.