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

Primary Purpose

Prostatism, Erectile Dysfunction

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dr. Pyke's Supplement for Stream (S4S)

About this trial

This is an interventional supportive care trial for Prostatism focused on measuring Benign Prostatic Hypertrophy, Erectile Dysfunction, Nutritional Supplements, Prostatism, Lower Urinary Tract Symptoms, male

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Once daily then twice daily

Twice daily then once daily

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Secondary safety outcome: Adverse event dropouts

Reports from subjects; number and % of patients

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

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

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

Full Information

NCT ID

NCT03681392

First Posted

September 20, 2018

Last Updated

December 4, 2021

Sponsor

Robert E. Pyke

1. Study Identification

Unique Protocol Identification Number

NCT03681392

Brief Title

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

Acronym

S4S4BPH/ED

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Robert E. Pyke

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatism, Erectile Dysfunction

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Once daily then twice daily

Arm Type

Experimental

Arm Description

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

Arm Title

Twice daily then once daily

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Dr. Pyke's Supplement for Stream (S4S)

Other Intervention Name(s)

S4S

Intervention Description

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

Primary Outcome Measure Information:

Title

International Prostate Symptom Score (IPSS)

Description

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

Time Frame

1-4 weeks

Title

Primary safety outcome: adverse events

Description

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

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Secondary safety outcome: Adverse event dropouts

Description

Reports from subjects; number and % of patients

Time Frame

1-2 weeks

Title

International Prostate Symptoms Scale Quality of Life due to urinary symptoms

Description

categorical single-item self-report from "delighted" to "terrible" plus brief write-in; % improving by at least 1 point

Time Frame

1-4 weeks

Title

Volunteer's Global Impression of Change in Erectile function

Description

categorical single-item self-report from "very much improved" to "worse" plus brief write-in; % improvement by at least 1 point

Time Frame

1 week

Title

International Index of Erectile Function (IIEF)-5

Description

5-item cluster on erectile function, score = 5 (worst possible) to 25 (completely normal); mean change and % improving by at least 2 points

Time Frame

1-4 weeks

Other Pre-specified Outcome Measures:

Title

Serious adverse events

Description

Rate of reported diagnoses from treating physicians if any subjects are hospitalized

Time Frame

2 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male prostate gland dysfunction is required

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert E Pyke, MD, PhD

Organizational Affiliation

Pykonsult LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Yes

Citations:

PubMed Identifier

30301704

Citation

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.

Results Reference

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

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