Last reviewed · How we verify
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)
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
Details
| Lead sponsor | Beijing Hospital of Traditional Chinese Medicine |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 160 |
| Start date | 2017-09 |
| Completion | 2018-12 |
Conditions
- Depression With Erectile Dysfunction
Interventions
- shu gan yi yang capsule
- shu gan yi yang capsule simulation agent
- Supportive psychotherapy
Primary outcomes
- change of The international index of erectile function (IIEF-5) total score — from baseline to endpoint(Week 8)
Each follow-up according to recent life situation, choose the best option for the 5 question, each item is scored 0-5,the total score of 5-7 divided into severe Erectile dysfunction, 8-11 divided into moderate Erectile dysfunction, 12-21 divided into mild Erectile dysfunction, 22-25 for not suffering from Erectile dysfunction (normal) - change of Montgomery Depression Rating Scale(MADRS)total score — from baseline to endpoint(Week 8)
Montgomery Depression Rating Scale includes 10 items, each item is scored 0-6 , extreme depression: MADRS≥35; severe depression: 35\> MADRS≥30; moderate depression: 30\> MADRS ≥ 22;Mild depression: 22\> MADRS ≥ 12; remission: MADRS \<12.