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

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.

Study Overview

• Status: Withdrawn
• Conditions: Erectile Dysfunction; Prostatism
• Intervention / Treatment: Dietary supplement: Dr. Pyke's Supplement for Stream (S4S)

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary safety outcome: Adverse event dropouts	Reports from subjects; number and % of patients	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	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	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	1-4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Rate of reported diagnoses from treating physicians if any subjects are hospitalized	2 weeks

Collaborators and Investigators

• Sponsor: Robert E. Pyke
• Investigators: Study Director: Robert E Pyke, MD, PhD, Pykonsult LLC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 4, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Benign Prostatic Hypertrophy; Nutritional Supplements; Prostatism; Lower Urinary Tract Symptoms, male
• Additional Relevant MeSH Terms: Mental Disorders; Urological Manifestations; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Lower Urinary Tract Symptoms; Erectile Dysfunction; Prostatism
• Other Study ID Numbers: Pykonsult 2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No