NCT05227508Unknown不适用
A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improved index in the IPSS test
研究概览
简要总结
A randomized, placebo controlled double-blind, 12-week treatment trial in men with moderate to severe symptoms of benign prostatic hyperplasia. The trail is about to examine the effect of Brizo® on reduction of BPH related symptoms.
详细描述
- Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia.
- 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients)
- Duration - 12 weeks with 3 visits: 0,6,12 weeks
- The following procedures are utilized:
- Physical exams - visit 1,3.
- Drugs/food supplement usage questionnaire - visit 1.
- Product supply Control - visit 1,2.3
- Clinical laboratory tests : psa, cbc, bun - visit 1,3.
- Uroflowmetry test visit - visit 1,3.
- IPSS- International Prostate Symptom Score - questionnaire - visit 1, 3.
- IIEF questionnaire - visit 1, 3.
- dosage: 1 capsule twice daily (morning & evening) can be taken with or without food
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia
排除标准
- •Inability to complete the questionnaire.
- •Patients with or suspected of having prostate cancer.
- •Patients who have undergone a surgical procedure in the past year and / or who have taken medications or supplements in the past six months to treat BPH.
- •Patients treated with drugs for kidney / urinary tract problems.
- •Allergy to soy.
研究组 & 干预措施
Brizo SC012
Experimental
A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING.
干预措施: BRIZO (Dietary Supplement)
PLACEBO
Placebo Comparator
A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING.
干预措施: placebo (Other)
结局指标
主要结局
Improved index in the IPSS test
时间窗: 12 weeks
Improvement by 3 points and with a significance of P\< 0.05.
次要结局
- Improve UROFLOWMETRY test(12 WEEKS)
研究者
研究点 (1)
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