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

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ClinicalTrials.gov Identifier: NCT03681392
Recruitment Status : Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Robert E. Pyke, drpykessupplements.com

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 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 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 1-4 weeks ]
    standard 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; number of patients with any adverse event, count and % of patients with each type of adverse event


Secondary Outcome Measures :
  1. Secondary safety outcome: Adverse event dropouts [ Time Frame: 1-2 weeks ]
    Reports from subjects; number and % of patients

  2. IPSS 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 ]
    Reports from treating physicians if subject allows sponsor to refer to his doctor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681392


Contacts
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Contact: Robert E Pyke, MD, PhD 2033992390 pykonsult@gmail.com
Contact: William R Pyke, B.A. 2033120257 robertepyke@gmail.com

Sponsors and Collaborators
Robert E. Pyke
Investigators
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Study Director: Robert E Pyke, MD, PhD Pykonsult LLC

Publications:
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Responsible Party: Robert E. Pyke, Trial Investigator, drpykessupplements.com
ClinicalTrials.gov Identifier: NCT03681392     History of Changes
Other Study ID Numbers: Pykonsult 2001
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet decided

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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:
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Erectile Dysfunction
Lower Urinary Tract Symptoms
Prostatism
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Urological Manifestations
Signs and Symptoms