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Clinical Study of ''Jieyu Xingyang decoction'' in treating erectile dysfunction caused by antipsychotic

Phase 3
Conditions
Erectile dysfunction due to antipsychotics
Registration Number
ITMCTR2200005913
Lead Sponsor
Affiliated Brain Hospital of Guangzhou Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

Inclusion criteria
(1) Male, aged 22 to 50 years old, with a regular sexual partner and regular sexual life;
(2) Meet the diagnostic criteria for schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) DSM-V;
And meet the DSM-V clinical stereotyped interview (SCID) results of schizophrenia.
(3) IIEF-5 score = 21 points;
(4) Those who have taken risperidone continuously within the past 2 weeks; and have not used drugs for erectile dysfunction in the past week, or have used such drugs and have been discontinued for more than 7 days;
(5) Meet the diagnostic criteria for erectile dysfunction syndrome of liver stagnation and kidney deficiency in the Guidelines for the Diagnosis and Treatment of Erectile Dysfunction (Trial Version);
(6) No language and hearing impairment;
(7) Those who are willing to accept traditional Chinese medicine treatment for 28 days, the subjects are informed, and voluntarily sign the informed consent;
If the answer to any of the above is No, the subject cannot participate.

Exclusion Criteria

Exclusion criteria
(1) Past history of mental illness:
? Other organic or drug-induced secondary mental illnesses cannot be excluded;
? There is a history of severe self-injury, suicidal tendencies and mental disorder;
? Those who have evidence of alcohol or other substance dependence or abuse;
? Patients with mental retardation or intellectual disability.
? Patients who do not cooperate due to excitement, impulsive injury, disorder of words and deeds, etc.
(2) External genital deformity and trauma;
(3) History of other physical diseases:
? One-year recovery period after the operation; ? Those who have had serious physical diseases within one year, such as gastric ulcer, chronic diarrhea and other gastrointestinal diseases, severe heart, lung,
Patients with liver and gallbladder, kidney and other diseases;
? Patients with severe neurological diseases such as epilepsy;
? There is a history of traumatic brain injury or organic diseases.
(4) Those who cannot insist on cooperating with treatment and follow-up.
If the answer to any of the above is yes, the subject cannot participate.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
octurnal Penite Tumescence;
Secondary Outcome Measures
NameTimeMethod
PANSS;Evaluation of syndrome of TCM;International Erectile Function Index-5;PPI;
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