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Tests treatment safety and results for Benign Prostatic Hyperplasia With Lower Urinary Tract...
Official title The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT05551221
What this study is testing
What is Silodosin Capsules?
Silodosin Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for benign prostatic hyperplasia with lower urinary tract symptoms.
Also referred to as Qianweitai.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 80, men only
You may be able to join if
- Male people 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.
- people who can read, understand, and complete the research questionnaire.
You likely can't join if
- people with prostate cancer or other malignant tumors.
- people have serum tPSA \> 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA \< 0.16 times.
- people suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- people have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper...
- people have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive...
- people have residual urine volume (PVR) \> 100ml, or those who may have urinary retention and need catheterization.
See the full eligibility criteria
- Male people 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.
- people who can read, understand, and complete the research questionnaire.
- people willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.
- people with prostate cancer or other malignant tumors.
- people have serum tPSA \> 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA \< 0.16 times.
- people suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- people have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency...
- people have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
- people have residual urine volume (PVR) \> 100ml, or those who may have urinary retention and need catheterization.
- people who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
- people who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
- people who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
- people who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.
- There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) \> 1.5 times of the upper limit of...
- people who are allergic to the drugs or ingredients used in the test definitely.
- Any otherSubjects in the opinion of researchers is not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Wuxi, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 60 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Wuhan, Hubei, China; Suzhou, Jiangsu, China; Wuxi, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.