NCT06064448

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

A Prospective, Multicenter, Randomized, Parallel and Positive Drug-controlled Clinical Study of Ningbitai Capsule in the Treatment of Chronic Pelvic Pain Syndrome With Erectile Dysfunction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Xintian Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Sample size: 214

Conditions

• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Erectile Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-19
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2023-10-03
• Last updated: 2023-10-12

Locations

1 site across 1 country: China