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Clinical Trial Scheme of Shu Gan yi Yang Capsule

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ClinicalTrials.gov Identifier: NCT03290313
Recruitment Status : Not yet recruiting
First Posted : September 21, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
Guizhou Yi Bai Pharmaceutical Co., Ltd.
Peking University Sixth Hospital
Beijing HuiLongGuan Hospital
Information provided by (Responsible Party):
Jie Zhang,BD, 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

Condition or disease Intervention/treatment Phase
Depression With Erectile Dysfunction Drug: shu gan yi yang capsule Drug: shu gan yi yang capsule simulation agent Other: Supportive psychotherapy Phase 4

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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
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

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




Primary Outcome Measures :
  1. change of The international index of erectile function (IIEF-5) total score [ Time Frame: 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)

  2. change of Montgomery Depression Rating Scale(MADRS)total score [ Time Frame: 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.


Secondary Outcome Measures :
  1. The change of total score of Hamilton Anxiety Scale (HAMA) [ Time Frame: 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)

  2. Change of traditional Chinese medicine syndrome integral [ Time Frame: 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

  3. A change in the effect of individual symptoms [ Time Frame: from baseline to endpoint(Week 8) ]
    Changes in each individual item of the scale were collected at each follow-up visit



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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290313


Contacts
Contact: lili zhang 010-58462584 1078002120@qq.com
Contact: yingbo zhao 13517212347 61773582@qq.com

Sponsors and Collaborators
Beijing Hospital of Traditional Chinese Medicine
Guizhou Yi Bai Pharmaceutical Co., Ltd.
Peking University Sixth Hospital
Beijing HuiLongGuan Hospital

Responsible Party: Jie Zhang,BD, Chief physician, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03290313     History of Changes
Other Study ID Numbers: DHZD-SGYY
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jie Zhang,BD, Beijing Hospital of Traditional Chinese Medicine:
Depression
erectile dysfunction
shu gan yi yang

Additional relevant MeSH terms:
Depression
Depressive Disorder
Erectile Dysfunction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological