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

NCT03681392 | Withdrawn

• 1 other identifier: Pykonsult 2001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatism; Erectile Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (4)

• Secondary safety outcome: Adverse event dropouts

  1-2 weeks

• International Prostate Symptoms Scale Quality of Life due to urinary symptoms

  1-4 weeks

• Volunteer's Global Impression of Change in Erectile function

  1 week

• International Index of Erectile Function (IIEF)-5

  1-4 weeks

Other Outcomes (1)

• Serious adverse events

  2 weeks

Study Arms (2)

Once daily then twice daily

EXPERIMENTAL

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)

Twice daily then once daily

EXPERIMENTAL

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)

Interventions

Dr. Pyke's Supplement for Stream (S4S) DIETARY_SUPPLEMENT

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

Also known as: S4S

Once daily then twice daily; Twice daily then once daily

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Male prostate gland dysfunction is required
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert E. Pyke: lead

Related 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.

  PMID: 30301704 BACKGROUND

MeSH Terms

Conditions

Prostatism; Erectile Dysfunction; Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Rivers

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Geological Phenomena; Physical Phenomena; Fresh Water; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Robert E Pyke, MD, PhD

  Pykonsult LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trial Investigator

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

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: December 20, 2021

Record last verified: 2021-12