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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100005426

Enrollment

Unknown

Registered

2021-12-19

Start date

2021-12-20

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Premature Ejaculation

Interventions

Control group:Oral Dapoxetine Hydrochloride, 30mg/time, take 2h before sexual intercourse

Control group:Oral Dapoxetine Hydrochloride, 60mg/time, take 2h before sexual intercourse

Observation group:Oral Zhuangdan Yanshi Decoction, decocted in water and taken twice in the morning and after dinner

Observation group: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.

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) Syndrome differentiation is biliary depression and phlegm disturbance; (3) 18=age=64 years old, the course of disease is more than 1 month; (3) The patient has a regular sex partner and has regular sex lives, and the number of sex lives =4 times per month; (4) Intravaginal ejaculation latency (IELT) <3 min (5) Volunteer to participate in this research.

Exclusion criteria

Exclusion criteria: ? Subjective PE, variability PE; ?Patients with erectile dysfunction (IIEF-5 score =21 points); ?Patients suffering from important diseases such as heart, liver, kidney, diabetes, and hyperthyroidism; ?Patients with urogenital diseases such as prostatitis and urethritis; ? Congenital developmental abnormalities of the reproductive system; ?Persons who have taken other PE drugs within 4 weeks or who have taken other drugs that affect ejaculation; ?Patients with mental illness and HADS=8 points; ? Those who have had a family plan in the past 6 months; ? Others who are not suitable for inclusion in the research.

Design outcomes

Primary

Measure	Time frame
IELT;Premature Ejaculation Efficacy Evaluation Scale;	—

Secondary

Measure	Time frame
PEP;CIPE-5;PEDT;	—

Countries

China

Contacts

Public ContactLiu Jianguo

kukuliushui@163.com15349212858

Outcome results

None listed

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