Trial | NCT03681392  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Jan 01
2021
Anticipated
Primary Completion
Dec 31
2022
Anticipated
Study Completion
Mar 31
2023
Anticipated
Last Update
Dec 20
2021

Dietary Supplement Dr. Pyke's Supplement for Stream (S4S) [citrulline, sitosterol, beta-, vitamin d3, ginseng]

Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3

  • Other names: S4S

Once daily then twice daily Experimental

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

Twice daily then once daily Experimental

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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.
Women
No Results Posted