Clinical Trial Scheme of Shu Gan yi Yang Capsule

Phase 4

• Conditions: Depression With Erectile Dysfunction
• Interventions: Drug: shu gan yi yang capsule simulation agent; Drug: shu gan yi yang capsule; Other: Supportive psychotherapy

• Registration Number: NCT03290313
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine

Brief 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

Study Timeline

• Study First Submitted: 2017-08-22
• Status Verified: 2017-09
• Study Start: 2017-09
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

1. Meet the diagnostic criteria for Western medicine in depression;
2. MADRS score ≥ 12 points and <30 points;
3. Diagnostic criteria for western medicine in line with erectile dysfunction，IIEF -5≤21points;
4. TCM syndrome differentiation of liver depression and kidney deficiency in accordance with depression and erectile dysfunction;
5. Male subjects, aged 22-65 years old;
6. 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;
7. The relationship between patients and sexual partners is stable (at least in the last 6 months);
8. Volunteer to participate in clinical trials, and sign informed consent.

Exclusion Criteria

1. A patient with major depressive disorder with psychotic symptoms or suicidal behavior;
2. A genital anatomical abnormality (such as severe penile fibrosis) or other organic sexual dysfunction with apparent impairment of erection;
3. Erectile dysfunction due to organic disease;
4. Unwilling to stop other patients for depression or erectile dysfunction therapy;
5. A person who has allergies or is sensitive to the ingredients of this test;
6. 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;
7. A patient with severe somatic disease;
8. Patients who have participated in other clinical trials in the past four weeks;
9. A history of drug abuse or alcoholism;
10. The researchers believe that patients who are not eligible for clinical trials are not eligible for clinical trials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shu gan yi yang capsule	Supportive psychotherapy	4 capsules / time, 3 times / day, taking 8 weeks
shu gan yi yang capsule capsule simulation agent	shu gan yi yang capsule simulation agent	4 capsules / time, 3 times / day, taking 8 weeks
shu gan yi yang capsule capsule simulation agent	Supportive psychotherapy	4 capsules / time, 3 times / day, taking 8 weeks
shu gan yi yang capsule	shu gan yi yang capsule	4 capsules / time, 3 times / day, taking 8 weeks

Primary Outcome Measures

Name	Time	Method
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.
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)

Secondary Outcome Measures

Name	Time	Method
The change of total score of Hamilton Anxiety Scale (HAMA)	from baseline to endpoint(Week 8)	Each time the follow-up score was based on the contents of the scale，Each item is scored 0-4(0=Asymptomatic，4=extreme）
Change of traditional Chinese medicine syndrome integral	from baseline to endpoint(Week 8)	Each time the follow-up score was based on the contents of the scale，Tongue pulse does not score
A change in the effect of individual symptoms	from baseline to endpoint(Week 8)	Changes in each individual item of the scale were collected at each follow-up visit