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

Recruiting Phase 4 Interventional Study
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 – 80
Sex
Male
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
312 (estimated)
Sponsor
Xintian Pharmaceutical · Industry
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About This Trial
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 Tamsulosi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male Subjects aged 60 ~ 80 years, clinically diagnosed as benign prostatic hyperplasia. 2. Has an IPSS score ≥ 8 points at Screening and Baseline. 3. Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume \> 150 ml. 4. Has a prostate volume (PV) ≥ 30 ml by ultrasound examination. 5. …
Contacts

Peiling Shi

+8619821240029

lc-spl@xtyyoa.com

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