Clinical trial NCT03681392: Study of Dr. Pyke's Supplement for Stream (S4S) in Men With Prostatism and 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostatism
Erectile Dysfunction
Keywords: Benign Prostatic Hypertrophy
Erectile Dysfunction
Nutritional Supplements
Prostatism
Lower Urinary Tract Symptoms, male
Lead sponsor: drpykessupplements.com
Sponsor class: INDUSTRY
First posted: 2018-09-24
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice daily
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 1-4 weeks
measure: Primary safety outcome: adverse events
timeFrame: 1 week
Secondary outcomes:
measure: Secondary safety outcome: Adverse event dropouts
timeFrame: 1-2 weeks
measure: International Prostate Symptoms Scale Quality of Life due to urinary symptoms
timeFrame: 1-4 weeks
measure: Volunteer's Global Impression of Change in Erectile function
timeFrame: 1 week
measure: International Index of Erectile Function (IIEF)-5
timeFrame: 1-4 weeks
Other outcomes:
measure: Serious adverse events
timeFrame: 2 weeks
Locations:
Study officials:
affiliation: Pykonsult LLC
name: Robert E Pyke, MD, PhD
role: STUDY_DIRECTOR
References:
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.