Abstract: Objective: To observe the curative effect of the therapy of Yangxue Danggui Capsules combined with Dydrogesterone on irregular menstruation and its influence on hormone levels. Methods:A total of 122 patients with irregular menstruation were selected and divided into the control group and the observation group by random number table method, with 61 cases in each group. The control group was treated with Dydrogesterone,and the observation group was treated with Dydrogesterone combined with Yangxue Danggui Capsules. The clinical effects and incidence of adverse reactions were compared between the two groups,and the changes of traditional Chinese medicine (TCM) syndrome scores,hormone levels, including luteinizing hormone (LH),follicle maturation hormone (FSH),estradiol (E2) and progesterone (P), menstrual condition, scores of Chinese Quality of Life (ChQOL) and scores of Pictorial Blood Loss Assessment Chart (PBAC) were compared before and after treatment between the two groups. Results: After six months of treatment,the total effective rate was 98.36 in the observation group,and 86.89% in the control group, the difference being significant (P<0.05). After treatment, the scores of main symptoms and secondary symptoms of TCM syndromes in the two groups were decreased when compared with those before treatment; after treatment, the scores of main symptoms and secondary symptoms of TCM syndromes in the observation group were lower than those in the control group (P< 0.05). After treatment,the levels of LH and FSH in the two groups were decreased when compared with those before treatment (P<0.05), and the levels of E2 and P were increased when compared with those before treatment (P<0.05);the levels of LH and FSH in the observation group were lower than those in the control group (P<0.05),and the levels of E2 and P were higher than those in the control group (P<0.05). After treatment, the menstruation volume and menstruation duration in patients with shortened menstruation and decreased menstruation volume in the two groups were increased when compared with those before treatment (P<0.05),and the menstruation volume and menstruation duration in patients with prolonged menstruation and increased menstruation volume in the two groups were decreased when compared with those before treatment (P<0.05); after treatment, the menstruation volume and menstruation duration in patients with shortened menstruation and decreased menstruation volume in the observation group were higher than those in the control group (P<0.05),and the menstruation volume and menstruation duration in patients with prolonged menstruation and increased menstruation volume in the two groups were lower than those in the control group (P<0.05). After treatment, the ChQOL scores in both groups were increased when compared with those before treatment (P<0.05),and the PBAC scores were decreased when compared with those before treatment (P<0.05); the ChQOL score in the observation group was higher than that in the control group (P<0.05),and the PBAC score was lower than that in the control group (P<0.05). During the treatment,the incidence of adverse reactions was 6.56% in the observation group and 3.28% in the control group,there being no significant difference in the incidence of adverse reactions between the two groups (P>0.05). Conclusion: The therapy of Yangxue Danggui Capsules combined with Dydrogesterone for irregular menstruation can improve clinical effects and quality of life, enhance hormone levels, promote the recovery of menstruation period, cycle and volume and improve menstrual status,with great medication safety.