Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT03681392
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT03681392
Study Brief:
Protocol Section:
NCT03681392