Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
160 participants
INTERVENTIONAL
2017-09-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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shu gan yi yang capsule
4 capsules / time, 3 times / day, taking 8 weeks
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
Supportive psychotherapy
Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
shu gan yi yang capsule capsule simulation agent
4 capsules / time, 3 times / day, taking 8 weeks
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
Supportive psychotherapy
Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
Interventions
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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
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
Supportive psychotherapy
Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
65 Years
MALE
No
Sponsors
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Guizhou Yi Bai Pharmaceutical Co., Ltd.
UNKNOWN
Peking University Sixth Hospital
OTHER
Beijing HuiLongGuan Hospital
OTHER
Beijing Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Jie Zhang,BD
Chief physician
Central Contacts
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Other Identifiers
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DHZD-SGYY
Identifier Type: -
Identifier Source: org_study_id