Back to results

Clinical Trial Scheme of Shu Gan yi Yang Capsule

Primary Purpose

Depression With Erectile Dysfunction

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

shu gan yi yang capsule

shu gan yi yang capsule simulation agent

Supportive psychotherapy

About this trial

This is an interventional treatment trial for Depression With Erectile Dysfunction focused on measuring Depression, erectile dysfunction, shu gan yi yang

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

shu gan yi yang capsule

shu gan yi yang capsule capsule simulation agent

Arm Description

4 capsules / time, 3 times / day, taking 8 weeks

Outcomes

Primary Outcome Measures

change of The international index of erectile function (IIEF-5) total score

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

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.

Secondary Outcome Measures

The change of total score of Hamilton Anxiety Scale (HAMA)

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

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

Changes in each individual item of the scale were collected at each follow-up visit

Full Information

NCT ID

NCT03290313

First Posted

August 22, 2017

Last Updated

September 21, 2017

Sponsor

Beijing Hospital of Traditional Chinese Medicine

Collaborators

Guizhou Yi Bai Pharmaceutical Co., Ltd., Peking University Sixth Hospital, Beijing HuiLongGuan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03290313

Brief Title

Clinical Trial Scheme of Shu Gan yi Yang Capsule

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2017 (Anticipated)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Hospital of Traditional Chinese Medicine

Collaborators

Guizhou Yi Bai Pharmaceutical Co., Ltd., Peking University Sixth Hospital, Beijing HuiLongGuan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression With Erectile Dysfunction

Keywords

Depression, erectile dysfunction, shu gan yi yang

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

shu gan yi yang capsule

Arm Type

Experimental

Arm Description

4 capsules / time, 3 times / day, taking 8 weeks

Arm Title

shu gan yi yang capsule capsule simulation agent

Arm Type

Placebo Comparator

Arm Description

4 capsules / time, 3 times / day, taking 8 weeks

Intervention Type

Drug

Intervention Name(s)

shu gan yi yang capsule

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

shu gan yi yang capsule simulation agent

Intervention Description

Intervention Type

Other

Intervention Name(s)

Supportive psychotherapy

Intervention Description

Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial

Primary Outcome Measure Information:

Title

change of The international index of erectile function (IIEF-5) total score

Description

Time Frame

from baseline to endpoint(Week 8)

Title

change of Montgomery Depression Rating Scale(MADRS)total score

Description

Time Frame

from baseline to endpoint(Week 8)

Secondary Outcome Measure Information:

Title

The change of total score of Hamilton Anxiety Scale (HAMA)

Description

Each time the follow-up score was based on the contents of the scale，Each item is scored 0-4(0=Asymptomatic，4=extreme）

Time Frame

from baseline to endpoint(Week 8)

Title

Change of traditional Chinese medicine syndrome integral

Description

Each time the follow-up score was based on the contents of the scale，Tongue pulse does not score

Time Frame

from baseline to endpoint(Week 8)

Title

A change in the effect of individual symptoms

Description

Changes in each individual item of the scale were collected at each follow-up visit

Time Frame

from baseline to endpoint(Week 8)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

lili zhang

Phone

010-58462584

1078002120@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

yingbo zhao

Phone

13517212347

61773582@qq.com

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial Scheme of Shu Gan yi Yang Capsule

We'll reach out to this number within 24 hrs