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Clinical Trial 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.


Clinical Trial Description

Sample size: 214 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06064448
Study type Interventional
Source Xintian Pharmaceutical
Contact
Status Completed
Phase Phase 4
Start date March 19, 2019
Completion date December 22, 2022

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