A Phase 2 Open-label Randomized Crossover Dose-finding Study of the Efficacy, Safety, and Tolerability of Dr. Pyke's Supplement for Stream (S4S) in Older Men With Lower Urinary Tract Symptoms and/or Sexual Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- International Prostate Symptom Score (IPSS)
研究概览
简要总结
This is the first clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3, to investigate its effects on prostatism and erections, and its tolerability, when taken daily and twice-daily for 2 weeks.
详细描述
This is a 2-week clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrullline, beta-sitosterol and vitamin D3, investigating its lower urinary tract effects, sexual effects, and tolerability in two dose regimens-daily for a week and twice daily for a week--in men who have Lower Urinary Tract Symptoms (LUTS) and may have erectile dysfunction (ED). No clinic visits are required. Subjects will be consented, screened, supplied with S4S, and tested via the Internet. Subset analyses will evaluate effects in three populations: men with at least moderate lower urinary tract symptoms (LUTS), according to standard score cutoff; men with at least moderate Erectile Dysfunction (ED, according to standard score cutoff; and all men dissatisfied with their urinary function and meeting minimal criteria for inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Inclusion requirements for all subjects
- •Men at least 40 years of age
- •Screening IPSS QoL must be 4-6:
- •If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6)
- •Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations
- •Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment
- •Required for target efficacy subset
- •Meets criterion for at least moderate ED: IIEF-5 (erectile function) score <13 - or:
- •Meets criterion for at least moderate Lower urinary tract symptoms (LUTS): IPSS score at least 20
排除标准
- •Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil.
- •Current severe side effects from any drug
- •Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study.
研究组 & 干预措施
Once daily then twice daily
One 6.5 cc scoop of S4S once a day for 7 days, then one 6.5 cc scoop of S4S twice a day for 7 days
干预措施: Dr. Pyke's Supplement for Stream (S4S) (Dietary Supplement)
Twice daily then once daily
One 6.5 cc scoop of S4S twice a day for 7 days, then one 6.5 cc scoop of S4S once a day for 7 days
干预措施: Dr. Pyke's Supplement for Stream (S4S) (Dietary Supplement)
结局指标
主要结局
International Prostate Symptom Score (IPSS)
时间窗: 1-4 weeks
measure of lower urinary tract symptoms in men with prostatism, total score; 0=best possible (no symptoms); 35 = worst possible; mean change and number of patients 50% improved
Primary safety outcome: adverse events
时间窗: 1 week
Reports from subjects of new or worse symptoms; number of patients with any adverse event, count and % of patients with each type of such adverse events
次要结局
- Volunteer's Global Impression of Change in Erectile function(1 week)
- International Prostate Symptoms Scale Quality of Life due to urinary symptoms(1-4 weeks)
- Secondary safety outcome: Adverse event dropouts(1-2 weeks)
- International Index of Erectile Function (IIEF)-5(1-4 weeks)
研究者
Robert E. Pyke
Trial Investigator
drpykessupplements.com