The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia

Official title

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

Overview

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.

Detailed description

Sample size: 312

Interventions

• Drug Silodosin Capsules
  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.
• Drug Ningmitai capsule
  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.
• Drug Tamsulosin
  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.

Primary outcome measures

• International Prostate Symptom Score（IPSS） [Time frame: 12 week]

Secondary outcome measures (11)

• International Prostate Symptom Score（IPSS） total score [Time frame: 1, 2, 4 and 8 weeks]
• IPSS Stimulus score [Time frame: 1, 2, 4 ,8 and 12 weeks]
• IPSS obstruction score [Time frame: 1, 2, 4 ,8 and 12 weeks]
• IPSS total score severity [Time frame: 12 week]
• Quality of life (QoL) score [Time frame: 4, 8 and 12 weeks]
• Maximum urinary flow rate (Qmax) [Time frame: 12 weeks]
• Residual urine volume (PVR) [Time frame: 12 weeks]
• Prostate specific antigen (PSA) [Time frame: 12 weeks]
• Prostate volume (PV) [Time frame: 12 weeks]
• Patient response rate [Time frame: 12 weeks]
• Proportion of patients with BPH clinical progression [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 8 centers

• Beijing Tiantan Hospital, Capital Medical University — Beijing
• Beijing Tongren Hospital, Capital Medical University — Beijing
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
• Peking University Shenzhen Hospital — Shenzhen
• The Central Hospital Of WUHAN — Wuhan
• Wuhan No.1 Hospital — Wuhan
• The Second Affiliated Hospital of Soochow University — Suzhou
• Wuxi No.2 People's Hospital — Wuxi

Identifiers

NCT: NCT05551221 · TREC2022-17

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗