Clinical Trial Scheme of Shu Gan yi Yang Capsule

NCT03290313 | Unknown Phase 4

• 1 other identifier: DHZD-SGYY
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Conditions

Depression With Erectile Dysfunction

Keywords

Depression; erectile dysfunction; shu gan yi yang

Outcome Measures

Primary Outcomes (2)

• 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)

  from baseline to endpoint(Week 8)

• 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.

  from baseline to endpoint(Week 8)

Secondary Outcomes (3)

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

  from baseline to endpoint(Week 8)

• Change of traditional Chinese medicine syndrome integral

  from baseline to endpoint(Week 8)

• A change in the effect of individual symptoms

  from baseline to endpoint(Week 8)

Study Arms (2)

shu gan yi yang capsule

EXPERIMENTAL

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

Drug: shu gan yi yang capsule; Other: Supportive psychotherapy

shu gan yi yang capsule capsule simulation agent

PLACEBO COMPARATOR

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

Drug: shu gan yi yang capsule simulation agent; Other: Supportive psychotherapy

Interventions

shu gan yi yang capsule DRUG

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

shu gan yi yang capsule

shu gan yi yang capsule simulation agent DRUG

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

shu gan yi yang capsule capsule simulation agent

Supportive psychotherapy OTHER

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

shu gan yi yang capsule; shu gan yi yang capsule capsule simulation agent

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead
• Guizhou Yi Bai Pharmaceutical Co., Ltd.: collaborator
• Peking University Sixth Hospital: collaborator
• Beijing HuiLongGuan Hospital: collaborator

MeSH Terms

Conditions

Depression; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

lili zhang

CONTACT

010-58462584; 1078002120@qq.com

yingbo zhao

CONTACT

13517212347; 61773582@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: September 21, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 25, 2017

Record last verified: 2017-09