NCT05551221

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

The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Xintian Pharmaceutical · Industry
• Sex: Male
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Sample size: 312

Conditions

• Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	Silodosin Capsules	Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner.
DRUG	Ningmitai capsule	Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.
DRUG	Tamsulosin	Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.

Timeline

• Start date: 2022-07-18
• Primary completion: 2023-12-31
• Completion: 2026-12-31
• First posted: 2022-09-22
• Last updated: 2022-09-23

Locations

8 sites across 1 country: China