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)
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 主要终点
- change of Montgomery Depression Rating Scale(MADRS)total score
研究概览
简要总结
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
详细描述
The study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
shu gan yi yang capsule
4 capsules / time, 3 times / day, taking 8 weeks
干预措施: shu gan yi yang capsule (Drug)
shu gan yi yang capsule
4 capsules / time, 3 times / day, taking 8 weeks
干预措施: Supportive psychotherapy (Other)
shu gan yi yang capsule capsule simulation agent
4 capsules / time, 3 times / day, taking 8 weeks
干预措施: shu gan yi yang capsule simulation agent (Drug)
shu gan yi yang capsule capsule simulation agent
4 capsules / time, 3 times / day, taking 8 weeks
干预措施: Supportive psychotherapy (Other)
结局指标
主要结局
change of Montgomery Depression Rating Scale(MADRS)total score
时间窗: from baseline to endpoint(Week 8)
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.
change of The international index of erectile function (IIEF-5) total score
时间窗: from baseline to endpoint(Week 8)
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)
次要结局
- The change of total score of Hamilton Anxiety Scale (HAMA)(from baseline to endpoint(Week 8))
- Change of traditional Chinese medicine syndrome integral(from baseline to endpoint(Week 8))
- A change in the effect of individual symptoms(from baseline to endpoint(Week 8))
研究者
Jie Zhang,BD
Chief physician
Beijing Hospital of Traditional Chinese Medicine