NCT06266000已完成4 期
A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Daily Urinary Frequency Log
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on lower urinary tract symptoms and urinary frequency in 120 generally healthy participants, 45 - 80 years.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged between 45-80
- •Mild to moderate in the IPSS
- •Generally healthy
- •Able to provide informed consent
- •Agree not to participate in another clinical trial while enrolled in this trial
- •Agree not the change their diet or exercise while enrolled in this trial
排除标准
- •Serious illness e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions (A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments)
- •Unstable illness e.g., diabetes and thyroid gland dysfunction (An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity)
- •Have used a drug/natural therapy for LUTS or other urological symptoms within the last 30 days?
- •Have had a urinary infection in the last 30 days or have, chronic urinary tract infections, or diagnosed chronic prostatitis
- •Have had urogenital surgery within the last 6 months.
- •Have had a bladder biopsy and/or cystoscopy and biopsy within the past 30 days.
- •Have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones)
- •Receiving/ prescribed Coumadin (Warfarin) or other anticoagulation therapy
- •Diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics.
- •Diagnosed cancer including prostatic cancer; if suspected by the investigator, refer for medical assessment
- •Active smokers and/or nicotine or drug abuse
- •Chronic alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in investigational, comparator or placebo formula
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participated in any other clinical trial during the past 1 month
研究组 & 干预措施
Saw palmetto extract
Experimental
Saw palmetto extract taken as 2 capsules per day
干预措施: Saw palmetto extract 320mg per day (Drug)
Comparator saw palmetto extract
Active Comparator
Commercial saw palmetto extract taken as 2 capsules per day
干预措施: Commercial Saw palmetto extract 320mg per day (Drug)
Placebo
Placebo Comparator
Palm oil taken as 2 capsules per day
干预措施: Palm Oil capsule (Drug)
结局指标
主要结局
Daily Urinary Frequency Log
时间窗: Baseline for 7 days, Days 21-27, Day 49-55, Day 77-83
Change from baseline to the end of the study period in Daily Urinary Frequency Diary
International Prostate Symptom Score (IPSS)
时间窗: Baseline, Day 28, Day 56, Day 84
Change from baseline to the end of the study period in the International Prostate Symptom Score (IPSS).The total score can range from 0 to 35 i.e. asymptomatic to very symptomatic.
次要结局
- Inflammatory marker - JM27(Baseline, Day 84)
- Liver Function (E/LFT) blood test(Baseline, Day 84)
- Brief Sexual Function Inventory (BSFI)(Baseline, Day 28, Day 56, Day 84)
- Electrolytes (E/LFT) blood test(Baseline, Day 84)
- International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)(Baseline, Day 84)
- Adverse event severity(During enrolment period)
- Blood pressure(Baseline, Day 84)
- Pulse rate(Baseline, Day 84)
- Adverse event frequency(During enrolment period)
- Discontinuation due to adverse events(During enrolment period)
研究者
研究点 (1)
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