Actively Recruiting
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
Led by Xintian Pharmaceutical · Updated on 2022-09-23
312
Participants Needed
8
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 60 to 80 years with clinical diagnosis of benign prostatic hyperplasia
- International Prostate Symptom Score (IPSS) of 8 points or higher at screening and baseline
- Maximum urinary flow rate (Qmax) between 4 and 15 ml/s with urination volume over 150 ml
- Prostate volume of 30 ml or more by ultrasound
- Ability to read, understand, and complete study questionnaires
- Willingness to participate voluntarily and provide signed informed consent
You will not qualify if you...
- Prostate cancer or other malignant tumors
- Serum total PSA over 10 ng/ml, or total PSA between 4 and 10 ng/ml with free PSA to total PSA ratio below 0.16
- Other diseases causing difficulty urinating such as bladder neck spasm, urethral stricture, or neurogenic bladder dysfunction
- Acute urinary retention or complications like gross hematuria, urinary tract infection, bladder stones, upper urinary tract hydronephrosis, urinary incontinence, or renal insufficiency
- History of prostate surgery, microwave therapy, urethral dilatation, acute urinary retention catheterization, or other invasive procedures
- Post-void residual urine volume greater than 100 ml or risk of urinary retention needing catheterization
- Use of alpha receptor blockers, traditional Chinese medicine, or botanical drugs for BPH within two weeks before the trial
- Use of 5-alpha reductase inhibitors or other antiandrogen therapies within six months before the trial
- Need for prohibited drugs or treatments during the study
- Severe cardiovascular, cerebrovascular, respiratory, blood, liver, or kidney diseases
- Significant abnormalities in clinical or lab tests such as elevated liver enzymes, creatinine, or poor blood glucose control
- Known allergy to the study drugs or their ingredients
- Any other condition deemed unsuitable for participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
3
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
4
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
5
The Central Hospital Of WUHAN
Wuhan, Hubei, China
Not Yet Recruiting
6
Wuhan No.1 Hospital
Wuhan, Hubei, China
Not Yet Recruiting
7
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
8
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
Not Yet Recruiting
Research Team
P
Peiling Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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