A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Lower Urinary Tract Symptoms (LUTS)
研究概览
简要总结
This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.
详细描述
This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.
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, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants aged 40+
- •Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination
- •Difficulty in getting or maintaining an erection
- •Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period
排除标准
- •Recent surgeries or invasive treatments
- •History of prostate or male reproductive cancers
- •Urinary issues caused by neurological conditions
- •Previous surgery on the genitals, prostate, bladder, or urethra
- •Known allergies to product ingredients
- •Diagnosed with chronic health conditions impacting study participation
- •Current substance abuse
- •Participation in other clinical trials
- •Taking medications or supplements targeting LUTS or erectile dysfunction
结局指标
主要结局
Change in Lower Urinary Tract Symptoms (LUTS)
时间窗: Baseline, Day 30, Day 60, and Day 90
Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS).
次要结局
- Change in Sexual Function and Performance(Baseline, Day 30, Day 60, and Day 90)