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
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Male
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:
• Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
• Has an IPSS score ≥ 8 points at Screening and Baseline.
• Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume \> 150 ml.
• Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
• Subjects who can read, understand, and complete the research questionnaire.
• Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.
Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The Central Hospital Of WUHAN
NOT_YET_RECRUITING
Wuhan
Wuhan No.1 Hospital
NOT_YET_RECRUITING
Wuhan
Wuxi No.2 People's Hospital
NOT_YET_RECRUITING
Wuxi
Contact Information
Primary
Peiling Shi
lc-spl@xtyyoa.com
+8619821240029
Time Frame
Start Date:2022-07-18
Estimated Completion Date:2026-12-31
Participants
Target number of participants:312
Treatments
Active_comparator: Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo
Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid.)
Experimental: Silodosin Capsules combine with Ningmitai Capsules placebo
Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid).
Experimental: Silodosin Capsules combine with Ningmitai Capsules
Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) and Ningmitai capsules (Ningmitai®, 0.38 g/capsule, 4 capsules/time, tid).