drugset / Trial / NCT05551221

The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia

NCT05551221

Phase 4 Recruiting 312 enrolled Xintian Pharmaceutical
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Objective: To evaluate the efficacy and safety of Ningmitai Capsules and Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Study design: A multicenter, prospective, randomized, double-blind, positive controlled clinical study. Interventions: Group A: Oral Tamsulosin Hydrochloride Capsules and Ningmitai Capsules placebo for 12 weeks. Group B: Oral l Silodosin Capsules and Ningmitai Capsules placebo for 12 weeks. Group C: Oral l Silodosin Capsules and Ningmitai Capsules for 12 weeks.

Timeline

Start
2022-07-18
Primary completion
2023-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ningmitai Traditional medicine (herbal / TCM) 0.38 g Oral
Subject Silodosin Unknown 4 mg Oral
Comparator Tamsulosin Other / unclassified Oral