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Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction

NCT06064448 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2023-10-12

No results posted yet for this study

Summary

Objective: The purpose of this study was to evaluate the clinical efficacy and safety of Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in the treatment of CP/CPPS with erectile dysfunction.

Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical study design was adopted.

Interventions:

① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.

② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals for 4 weeks continuously.

③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken continuously for 4 weeks.

Conditions

Interventions

DRUG

Sildenafil

Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.

DRUG

Ningmitai capsule

The subjects took Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, after meals, and continued to treat for 4 weeks.

DRUG

Ningbitai capsule + sildenafil

The subjects took Ningmitai capsule orally, 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals. Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.

Sponsors & Collaborators

  • Xintian Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Deng Chunhua, Doctor · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2022-12-22
Completion
2022-12-22

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06064448 on ClinicalTrials.gov