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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3
International Prostate Symptom Score (IPSS)
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
Time frame: 1-4 weeks
Primary safety outcome: adverse events
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
Time frame: 1 week
Secondary safety outcome: Adverse event dropouts
Reports from subjects; number and % of patients
Time frame: 1-2 weeks
International Prostate Symptoms Scale Quality of Life due to urinary symptoms
categorical single-item self-report from "delighted" to "terrible" plus brief write-in; % improving by at least 1 point
Time frame: 1-4 weeks
Volunteer's Global Impression of Change in Erectile function
categorical single-item self-report from "very much improved" to "worse" plus brief write-in; % improvement by at least 1 point
Time frame: 1 week
International Index of Erectile Function (IIEF)-5
5-item cluster on erectile function, score = 5 (worst possible) to 25 (completely normal); mean change and % improving by at least 2 points
Time frame: 1-4 weeks
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