The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study
Xintian Pharmaceutical
312 participants
Jul 18, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Male Subjects 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.
- Subjects who can read, understand, and complete the research questionnaire.
- Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.
Exclusion Criteria13
- Subjects with prostate cancer or other malignant tumors.
- Subjects have serum tPSA \> 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA \< 0.16 times.
- Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- Subjects 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 and other Subjects that researchers believe meet the surgical indications.
- Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
- Subjects have residual urine volume (PVR) \> 100ml, or those who may have urinary retention and need catheterization.
- Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
- Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
- Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
- Subjects 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 reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L).
- Subjects 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner.
Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.
Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05551221