Title
Clinical Trial Scheme of Shu Gan yi Yang Capsule
a Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial of Efficacy and Safety of Shu Gan yi Yang Capsule in the Treatment of Depression Associated With Erectile Dysfunction (Stagnation of Liver qi and Kidney Deficiency)
Phase
Phase 4Lead Sponsor
Capital Medical UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Depression With Erectile DysfunctionIntervention/Treatment
shu gan yi yang capsule shu gan yi yang capsule simulation agent ...Study Participants
160Shu gan yi yang capsule is made of traditional Chinese medicine Guizhou Yi Bai pharmaceutical Limited by Share Ltd, for liver and kidney deficiency and liver and kidney deficiency and blood stasis caused by functional impotence and mild arterial insufficiency in impotence, impotence, flaccid penis not hard or lift and not firm, chest deep sigh, chest fullness, soreness and weakness of waist and knees, pale tongue or petechiae, pulse string or string. The choice of depression associated with erectile dysfunction patients, and investigate its effect.In this study, patients with depression and erectile dysfunction were selected and the efficacy was investigated
The study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation
Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
4 capsules / time, 3 times / day, taking 8 weeks
4 capsules / time, 3 times / day, taking 8 weeks
Inclusion Criteria: Meet the diagnostic criteria for Western medicine in depression; MADRS score ≥ 12 points and <30 points; Diagnostic criteria for western medicine in line with erectile dysfunction，IIEF -5≤21points; TCM syndrome differentiation of liver depression and kidney deficiency in accordance with depression and erectile dysfunction; Male subjects, aged 22-65 years old; Patients who have not been treated with antidepressants or have been treated with antidepressants for more than 1 months and have reached treatment doses have no need to adjust their medications and dosages within 2 months; The relationship between patients and sexual partners is stable (at least in the last 6 months); Volunteer to participate in clinical trials, and sign informed consent. Exclusion Criteria: A patient with major depressive disorder with psychotic symptoms or suicidal behavior; A genital anatomical abnormality (such as severe penile fibrosis) or other organic sexual dysfunction with apparent impairment of erection; Erectile dysfunction due to organic disease; Unwilling to stop other patients for depression or erectile dysfunction therapy; A person who has allergies or is sensitive to the ingredients of this test; Combined with severe primary liver and kidney diseases, aspartate aminotransferase , Alanine aminotransferase exceeded 1.5 times the normal value, and creatinine exceeded the normal limit; A patient with severe somatic disease; Patients who have participated in other clinical trials in the past four weeks; A history of drug abuse or alcoholism; The researchers believe that patients who are not eligible for clinical trials are not eligible for clinical trials.
