RecruitingPhase 4NCT05551221

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


Sponsor

Xintian Pharmaceutical

Enrollment

312 participants

Start Date

Jul 18, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for benign prostatic hyperplasia (BPH) — an enlarged prostate that makes it difficult to urinate. The two treatments being tested are silodosin (a medication that relaxes the prostate) used alone, versus silodosin combined with Ningmitai capsules (a traditional Chinese medicine). Researchers want to see which approach is more effective and safer for older men with bothersome urinary symptoms. You may be eligible if: - You are male and between 60 and 80 years old - You have been diagnosed with BPH - Your symptom score (IPSS) is 8 or higher - Your urine flow rate (Qmax) is between 4 and 15 mL/s with adequate urine volume - Your prostate volume is 30 mL or larger by ultrasound You may NOT be eligible if: - You have prostate cancer or any other cancer - Your PSA levels indicate a possible cancer risk - You have bladder, urethral, or nerve-related causes of your urinary symptoms - You have had prostate surgery, microwave therapy, or other invasive procedures - You have taken alpha blockers or certain other prostate medications recently - You have serious heart, liver, kidney, blood, or respiratory disease - You have poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSilodosin 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.

DRUGNingmitai 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.

DRUGTamsulosin

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

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NCT05551221


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