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

NCT ID: NCT03681392

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Prostatism Erectile Dysfunction

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dr. Pyke's Supplement for Stream (S4S)

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

Dr. Pyke's Supplement for Stream (S4S)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Dr. Pyke's Supplement for Stream (S4S)

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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S4S

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Robert E. Pyke

INDUSTRY

Sponsor Role lead

Responsible Party

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Robert E. Pyke

Trial Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert E Pyke, MD, PhD

Role: STUDY_DIRECTOR

Pykonsult LLC

References

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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.

Reference Type BACKGROUND
PMID: 30301704 (View on PubMed)

Other Identifiers

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Pykonsult 2001

Identifier Type: -

Identifier Source: org_study_id