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

Erectile Dysfunction Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03681392
• Other study ID #: Pykonsult 2001
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 2023

Study information

• Verified date: December 2021
• Source: drpykessupplements.com
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Lower Urinary Tract Symptoms
• Prostatism

Intervention

Dietary Supplement:
• Dr. Pyke's Supplement for Stream (S4S)
Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Robert E. Pyke

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serious adverse events	Rate of reported diagnoses from treating physicians if any subjects are hospitalized	2 weeks
Primary	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	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	Secondary safety outcome: Adverse event dropouts	Reports from subjects; number and % of patients	1-2 weeks
Secondary	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
Secondary	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
Secondary	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