Depression With Erectile Dysfunction Clinical Trial
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)
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
| Status | Not yet recruiting |
| Enrollment | 160 |
| Est. completion date | December 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 22 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Hospital of Traditional Chinese Medicine | Beijing HuiLongGuan Hospital, Guizhou Yi Bai Pharmaceutical Co., Ltd., Peking University Sixth Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Secondary | 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) | |
| Secondary | Change of traditional Chinese medicine syndrome integral | 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) | |
| Secondary | 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) |