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

• ClinicalTrials.gov Identifier: NCT03681392
• Recruitment Status: Withdrawn
• First Posted: September 24, 2018
• Last Update Posted: December 20, 2021
• Sponsor: Robert E. Pyke
• Information provided by (Responsible Party): Robert E. Pyke, drpykessupplements.com

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)	Not Applicable

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 (Clinical Trial)
• 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 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
• Estimated Study Start Date: January 1, 2021
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: March 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 Name: 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 Name: S4S

Outcome Measures

Primary Outcome Measures :

1. International Prostate Symptom Score (IPSS) [ Time Frame: 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
2. Primary safety outcome: adverse events [ Time Frame: 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 :

1. Secondary safety outcome: Adverse event dropouts [ Time Frame: 1-2 weeks ]
   Reports from subjects; number and % of patients
2. International Prostate Symptoms Scale Quality of Life due to urinary symptoms [ Time Frame: 1-4 weeks ]
   categorical single-item self-report from "delighted" to "terrible" plus brief write-in; % improving by at least 1 point
3. Volunteer's Global Impression of Change in Erectile function [ Time Frame: 1 week ]
   categorical single-item self-report from "very much improved" to "worse" plus brief write-in; % improvement by at least 1 point
4. International Index of Erectile Function (IIEF)-5 [ Time Frame: 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:

1. Serious adverse events [ Time Frame: 2 weeks ]
   Rate of reported diagnoses from treating physicians if any subjects are hospitalized

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male prostate gland dysfunction is required
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Inclusion requirements for all subjects

1. Men at least 40 years of age

2. 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)

3. Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations
4. 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:

1. Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil.
2. Current severe side effects from any drug
3. Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study.
4. Women

Contacts and Locations

Sponsors and Collaborators

Robert E. Pyke

Investigators

• Study Director: Robert E Pyke, MD, PhD; Pykonsult LLC

More Information

Publications:

Pyke RE. Exo-Clinical Trials of Nutritional Supplements for Sexual Dysfunction: Precedents, Principles, and Protocols. Sex Med Rev. 2019 Apr;7(2):251-258. doi: 10.1016/j.sxmr.2018.07.002. Epub 2018 Oct 6. Review.

• Responsible Party: Robert E. Pyke, Trial Investigator, drpykessupplements.com
• ClinicalTrials.gov Identifier: NCT03681392
• Other Study ID Numbers: Pykonsult 2001
• First Posted: September 24, 2018
• Last Update Posted: December 20, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert E. Pyke, drpykessupplements.com:

Benign Prostatic Hypertrophy; Erectile Dysfunction; Nutritional Supplements; Prostatism; Lower Urinary Tract Symptoms, male

Additional relevant MeSH terms:

Erectile Dysfunction; Lower Urinary Tract Symptoms; Prostatism; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Urological Manifestations