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a Random, Double-blind, Double-simulation, Multicenter study of Chinese Herbal Compound Jinji Granules (CJG) for treatment Primary Premature Ejaculation: (Gan depression an Shen deficiency syndrome)

Not Applicable
Recruiting
Conditions
Premature ejaculation
Registration Number
ITMCTR2200005688
Lead Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

(1)Meet the diagnostic criteria of Western medicine for premature ejaculation;
(2)Meet the standard of TCM syndrome differentiation.
(3)The course of disease is more than 1 year.
(4)23=age=50.
(5)Sexual frequency=1 time/week, at least 6 times a month.
(6)At least in the last 3 months and during the course of this study, the subject had stable marital relationship or stable adult female sexual partner.
(7)Normal erectile function, IIEF-5 score > 21 [20-23].
(8)Subjects agree not to use any other drugs for premature ejaculation during the study period, including 5-HT inhibitors, Chinese herbal medicines (including decoction and proprietary Chinese medicine), or devices used for PE treatment.
(9)Subjects (including partners) guarantee that they have no birth plan and voluntarily use appropriate contraceptive measures during the study period up to 3 months after the last medication.
(10)The subject voluntarily signs the informed consent.

Exclusion Criteria

(1)Patients with urinary and reproductive tract infection, such as urethritis, prostatitis, etc.;
(2)Patients with diabetes and neurological diseases;
(3)Patients with cardiovascular diseases;
(4)Patients with liver and kidney dysfunction;
(5)Persons who abuse psychotropic drugs;
(6)Patients with other sexual dysfunction;
(7)Patients who are being treated with other drugs.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intravaginal ejaculatory latency time(IELT);
Secondary Outcome Measures
NameTimeMethod
Premature ejaculation Profile(PEP);Traditional Chinese medicine syndrome score;clinical global impression (CGI) of change;
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