S4S4BPH/ED: Study of Dr. Pyke's Supplement for Stream (S4S) in Men With Prostatism and ED

Sponsor

Robert E. Pyke (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03681392

Collaborator

(none)

Enrollment

Arms

25.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostatism Erectile Dysfunction	Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice dailyRandomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice daily

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S) Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3 Other Names: S4S
Experimental: 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	Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S) Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3 Other Names: S4S

Arm

Intervention/Treatment

Experimental: 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

Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)

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

Other Names:

S4S

Experimental: 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

Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)

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

Other Names:

S4S

Outcome Measures

Primary Outcome Measures

International Prostate Symptom Score (IPSS) [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 [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

Secondary Outcome Measures

Secondary safety outcome: Adverse event dropouts [1-2 weeks]
Reports from subjects; number and % of patients
International Prostate Symptoms Scale Quality of Life due to urinary symptoms [1-4 weeks]
categorical single-item self-report from "delighted" to "terrible" plus brief write-in; % improving by at least 1 point
Volunteer's Global Impression of Change in Erectile function [1 week]
categorical single-item self-report from "very much improved" to "worse" plus brief write-in; % improvement by at least 1 point
International Index of Erectile Function (IIEF)-5 [1-4 weeks]
5-item cluster on erectile function, score = 5 (worst possible) to 25 (completely normal); mean change and % improving by at least 2 points

Other Outcome Measures

Serious adverse events [2 weeks]
Rate of reported diagnoses from treating physicians if any subjects are hospitalized

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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