Actively Recruiting
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms
Led by Xintian Pharmaceutical · Updated on 2022-09-23
312
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Ningmitai Capsules combined with Silodosin Capsules compared to Tamsulosin Hydrochloride Sustained Release Capsules in treating men aged 60 to 80 years with Benign Prostatic Hyperplasia (BPH) accompanied by Lower Urinary Tract Symptoms (LUTS). This is a multicenter, prospective, randomized, double-blind, positive controlled clinical study involving 312 participants. The study aims to better understand treatment options for BPH with LUTS by comparing these therapies. Participants are divided into three groups for 12 weeks of treatment. Group A receives oral Tamsulosin Hydrochloride Capsules once daily plus a placebo matching Ningmitai Capsules. Group B takes Silodosin Capsules twice daily after meals plus a placebo matching Ningmitai Capsules. Group C receives both Silodosin Capsules twice daily and Ningmitai Capsules three times daily. Each treatment follows specified dosages and schedules, with placebos used to maintain blinding. During the trial, participants will undergo assessments including the International Prostate Symptom Score (IPSS) at multiple intervals up to 12 weeks. Other measurements include quality of life scores, urinary flow rates, prostate volume, residual urine volume, prostate specific antigen levels, and clinical progression rates. These evaluations will help monitor symptoms, treatment response, and safety. The study includes careful monitoring and informed consent to ensure participant well-being throughout the trial period.
CONDITIONS
Brief 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 a 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 confirmed by ultrasound.
- Ability to read, understand, and complete research questionnaires.
- Willingness to participate voluntarily and provide signed informed consent.
You will not qualify if you...
- Presence of 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/total PSA ratio less than 0.16.
- Other causes of urinary difficulties, such as bladder neck spasm, urethral stricture, or neurogenic bladder dysfunction.
- History of acute urinary retention, gross hematuria, urinary tract infection, bladder stones, upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency, or surgical indications.
- Previous prostate surgery, microwave therapy, urethral dilatation, acute urinary retention catheterization, or other invasive procedures.
- Residual urine volume above 100 ml or risk of urinary retention requiring 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 to take prohibited drugs or treatments during the study.
- Severe cardiovascular, cerebrovascular, respiratory, blood, liver, or kidney diseases.
- Significant clinical or laboratory abnormalities such as elevated liver enzymes, creatinine, or poor blood sugar control.
- Known allergies to study drugs or ingredients.
- Any other condition deemed unsuitable by researchers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive assigned capsules (Silodosin, Ningmitai, Tamsulosin, or placebos) to treat benign prostatic hyperplasia. They take medications daily according to their assigned group.
Visits at Weeks 1, 2, 4, 8, and 12 for assessments
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
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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