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)

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

Study Overview

• Status: Unknown
• Conditions: Depression With Erectile Dysfunction
• Intervention / Treatment: Drug: shu gan yi yang capsule; Other: Supportive psychotherapy; Drug: shu gan yi yang capsule simulation agent

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: shu gan yi yang capsule; 4 capsules / time, 3 times / day, taking 8 weeks	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; Other: Supportive psychotherapy; Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
PLACEBO_COMPARATOR: shu gan yi yang capsule capsule simulation agent; 4 capsules / time, 3 times / day, taking 8 weeks	Other: Supportive psychotherapy; Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）	from baseline to endpoint(Week 8)
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	from baseline to endpoint(Week 8)
A change in the effect of individual symptoms	Changes in each individual item of the scale were collected at each follow-up visit	from baseline to endpoint(Week 8)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (ACTUAL): September 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Depression; erectile dysfunction; shu gan yi yang
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Depression; Depressive Disorder; Erectile Dysfunction
• Other Study ID Numbers: DHZD-SGYY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No