Clinical Trial Scheme of Shu Gan yi Yang Capsule

Beijing Hospital of Traditional Chinese Medicine

Status and phase: Unknown; Phase 4

Conditions: Depression With Erectile Dysfunction

Treatments: Drug: shu gan yi yang capsule; Other: Supportive psychotherapy; Drug: shu gan yi yang capsule simulation agent

Study type: Interventional

Funder types: Other

Identifiers

NCT03290313

DHZD-SGYY

Details and patient eligibility

About

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

Full description

The study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation

Enrollment: 160 estimated patients

Sex: Male

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

shu gan yi yang capsule

Experimental group

Description:

4 capsules / time, 3 times / day, taking 8 weeks

Treatment:

Other: Supportive psychotherapy

Drug: shu gan yi yang capsule

shu gan yi yang capsule capsule simulation agent

Placebo Comparator group

Description:

4 capsules / time, 3 times / day, taking 8 weeks

Treatment:

Other: Supportive psychotherapy

Drug: shu gan yi yang capsule simulation agent