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

Study Overview
=================
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.

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

Conditions
-----------------
Prostatism, Erectile Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion requirements for all subjects 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice daily
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once daily then twice daily<br>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)<br>* Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3<br>* Other names: S4S;|
| Experimental: Twice daily then once daily<br>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)<br>* Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3<br>* Other names: S4S;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary safety outcome: Adverse event dropouts | Reports from subjects; number and % of patients | 1-2 weeks | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatism, Benign Prostatic Hypertrophy, Erectile Dysfunction, Nutritional Supplements, Lower Urinary Tract Symptoms, male