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A multicenter study to observe the clinical efficacy of "Da Jing" combined with tadalafil in the treatment of patients with moderate to severe erectile dysfunction

A multicenter study to observe the clinical efficacy of "Da Jing" combined with tadalafil in the treatment of patients with moderate to severe erectile dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089539
Enrollment
Unknown
Registered
2024-09-10
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Erectile dysfunction

Interventions

Test group:"Da Jing" (3 capsules/day) combined with PDE5I (tadalafil) treatment
Control groups:"Placebo" (3 capsules/day) + PDE5I (tadalafil) monotherapy.

Sponsors

Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) 20 years = age = 60 years; (2) IIEF-5 = 11; (3) Meets the western medical diagnosis (persistent inability of the penis to achieve or maintain an erection sufficient to accomplish a satisfactory sexual life); (4) Having a stable partner and regular sexual life; (5) Not taking drugs that affect this clinical study within 1 month; (6) Those who voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) ED due to spinal cord injury, history of radical prostatectomy, or trauma; (2) Those with penile deformity or genital dysplasia; (3) Those with a combination of severe cardiovascular or cerebrovascular diseases or other organ diseases; (4) People with mental disorder diseases; (5) People with contraindications or allergies to the study drug; (6) Those who have inflammation or stones in the genitourinary system; (7) Those who are receiving tumor chemotherapy, anti-androgen therapy; (8) Participating in other drug experiments at the same time or poor compliance.

Design outcomes

Primary

MeasureTime frame
Brief International Erectile Function Questionnaire (IIEF-5);Erectile Hardness Scale (EHS);

Secondary

MeasureTime frame
Anxiety Symptoms Screening Scale (GAD-7);PHQ-9 Depression Screening Scale;

Countries

China

Contacts

Public ContactKaifeng Liu

Northern Jiangsu People's Hospital Affiliated to Yangzhou University

18051062336@yzu.edu.cn+86 180 5106 2336

Outcome results

None listed

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