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The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
Sponsor: Xintian Pharmaceutical
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.
Official title: 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
Key Details
Gender
MALE
Age Range
60 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2022-07-18
Completion Date
2026-12-31
Last Updated
2022-09-23
Healthy Volunteers
No
Interventions
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.
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.
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.
Locations (8)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Central Hospital Of WUHAN
Wuhan, Hubei, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China