NCT03290313

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Beijing Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: Male
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Shu 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

Detailed description

The study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation

Conditions

• Depression With Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	shu gan yi yang capsule	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
DRUG	shu gan yi yang capsule simulation agent	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
OTHER	Supportive psychotherapy	Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2017-09-21
• Last updated: 2017-09-25