drugset / Trial / NCT06064448

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

NCT06064448

Phase 4 Completed 254 enrolled Xintian Pharmaceutical
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Ningmitai capsule Traditional medicine (herbal / TCM) 0.38 g Oral
Comparator Sildenafil Unknown 25 mg Oral