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| Name | Class |
|---|---|
| Guizhou Yi Bai Pharmaceutical Co., Ltd. | UNKNOWN |
| Peking University Sixth Hospital | OTHER |
| Beijing HuiLongGuan Hospital | OTHER |
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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
The study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| shu gan yi yang capsule | Experimental | 4 capsules / time, 3 times / day, taking 8 weeks |
|
| shu gan yi yang capsule capsule simulation agent | Placebo Comparator | 4 capsules / time, 3 times / day, taking 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shu gan yi yang capsule | Drug | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lili zhang | Contact | 010-58462584 | 1078002120@qq.com | |
| yingbo zhao | Contact | 13517212347 | 61773582@qq.com |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
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| shu gan yi yang capsule simulation agent | Drug | 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 | Other | Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial |
|
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) |
| D000091642 |
| Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |