To observe the efficacy and safety of Shugan Yiyang capsule on emotion,erectile function,TCM syndromes and symptoms of depression patients with erectile dysfunction.Methods:A total of 154 outpatients in the department of psychiatry or psychosomatic medicine in 7 hospitals including Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University from November 2017 to November 2019 were randomly divided into an study group of 115 and a control group of 39 according to the ratio of 3:1.The study group was treated with Shugan Yiyang capsule,and the control group was treated with placebo,both for 8 weeks.Patients' mood,erectile function,TCM syndrome and safety were observed.Results:After treatment,the total effective rate of depression in study group was higher than that in the control group(P<0.05),and the total effective rate of anxiety was higher than that in the control group(P<0.05).The total effective rate of TCM syndrome curative effect in the study group was higher than that in the control group(P<0.05).The improvement of single symptom curative effect grades in depression,chest distress,soreness of waist and knee,and dizziness and tinnitus were higher than those in the control group(P<0.05).The disappearance rate of single symptom in soreness of waist and knee,dizziness and tinnitus was higher than that in the control group(P<0.05).There were no statistically significant adverse events between the two groups.Conclusion:Shugan Yiyang capsule can significantly improve depression and anxiety in patients with depression and erectile dysfunction,and significantly alleviate the TCM syndromes of liver depression and kidney deficiency,depression,chest tightness and excessive breath,soreness of waist and knee,dizziness and tinnitus with good clinical safety.