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.
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. …
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