NCT03681392

Study of Dr. Pyke's Supplement for Stream (S4S) in Men With Prostatism and ED

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Robert E. Pyke · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatism
• Erectile Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dr. Pyke's Supplement for Stream (S4S)	Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2018-09-24
• Last updated: 2021-12-20