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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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
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
Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
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)
Time frame: 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.
Time frame: from baseline to endpoint(Week 8)
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)
Time frame: from baseline to endpoint(Week 8)
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
Time frame: 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
Time frame: from baseline to endpoint(Week 8)
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