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

Официальное название

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

Обзор

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.

Подробное описание

Sample size: 312

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• International Prostate Symptom Score（IPSS） [Срок оценки: 12 week]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 8 центров

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

Идентификаторы

NCT: NCT05551221 · TREC2022-17

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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