Clinical trial NCT03290313: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depression With Erectile Dysfunction
Keywords: Depression
erectile dysfunction
shu gan yi yang
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guizhou Yi Bai Pharmaceutical Co., Ltd.
name: Peking University Sixth Hospital
name: Beijing HuiLongGuan Hospital
First posted: 2017-09-21
Enrollment: 160
Sex: MALE
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: change of The international index of erectile function (IIEF-5) total score
timeFrame: from baseline to endpoint(Week 8)
measure: change of Montgomery Depression Rating Scale(MADRS)total score
timeFrame: from baseline to endpoint(Week 8)
Secondary outcomes:
measure: The change of total score of Hamilton Anxiety Scale (HAMA)
timeFrame: from baseline to endpoint(Week 8)
measure: Change of traditional Chinese medicine syndrome integral
timeFrame: from baseline to endpoint(Week 8)
measure: A change in the effect of individual symptoms
timeFrame: from baseline to endpoint(Week 8)
Other outcomes:
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Study officials:
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