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