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Clinical observation of Zhuangdan Yanshi Decoction combined with dapoxetine in the treatment of premature ejaculation

Clinical observation of Zhuangdan Yanshi Decoction combined with dapoxetine in the treatment of premature ejaculation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054538
Enrollment
Unknown
Registered
2021-12-19
Start date
2021-12-20
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

Interventions

Control group1:Oral Dapoxetine Hydrochloride, 30mg/time, take 2h before sexual intercourse
Experimental group1:Oral Zhuangdan Yanshi Decoction, decocted in water and taken twice in the morning and after dinner
Control group2:Oral Dapoxetine Hydrochloride, 60mg/time, take 2h before sexual intercourse
Experimental group2:Oral Zhuangdan Yanshi Decoction, decocted twice in the morning and evening, and after dinner, plus Dapoxetine Hydrochloride, 60 mg/time, taken 2 hours before sexual intercourse.

Sponsors

Shaanxi Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for premature ejaculation; 2. Diagnosis of gallbladder depression and phlegm disturbance; 3. Aged 18 to 64 years, the course of disease is more than 1 month; 4. The patient has a fixed sexual partner and has regular sexual life, and the number of sexual life is >= 4 times per month; 5. Intravaginal ejaculation latency time (IELT) < 3 min; 6. Voluntary participation in this study.

Exclusion criteria

Exclusion criteria: 1. Subjective PE, variable PE; 2. Patients with erectile dysfunction (IIEF-5 score = 8 points; 8. Those who have had family planning in the past 6 months; 9. Others are not suitable for inclusion in the researcher.

Design outcomes

Primary

MeasureTime frame
intravaginal ejaculation latency;Premature Ejaculation Efficacy Evaluation Scale;

Secondary

MeasureTime frame
Premature Ejaculation Diagnostic Scale;5 items of sexual function evaluation of Chinese premature ejaculation patients;Premature Ejaculation Assessment Scale;

Countries

China

Contacts

Public ContactLiu Jianguo

Shaanxi Provincial Hospital of Traditional Chinese Medicine

kukuliushui@163.com+86 15349212858

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026