Status:
UNKNOWN
Clinical Trial Scheme of Shu Gan yi Yang Capsule
Lead Sponsor:
Beijing Hospital of Traditional Chinese Medicine
Collaborating Sponsors:
Guizhou Yi Bai Pharmaceutical Co., Ltd.
Peking University Sixth Hospital
Conditions:
Depression With Erectile Dysfunction
Eligibility:
MALE
22-65 years
Phase:
PHASE4
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 cau...
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
- 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
- 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.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03290313
Start Date
September 1 2017
End Date
December 1 2018
Last Update
September 25 2017
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