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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT00985335
Eligibility Criteria:
Inclusion Criteria:
1. Participant has signs and symptoms of HSV-1 infection of less than 24 hours duration to the Southern California University of Health Sciences investigators
2. Participants ages 18-70 years
3. Confirmation of oral-circumoral herpes lesion will be made by a clinician in the presence of oral-circumoral lesion assumed to be HSV-1 for purposes of study
4. Subjects expressed willingness to comply with protocol
5. Subject will be willing to have the presenting lesion photographed twice
6. Subject sign a written informed consent, HIPPA disclosure, Experimental bill of rights
Exclusion Criteria:
1. History of past or present immunosuppressive condition, or currently taking immunosuppressive medication
2. History of adverse effects or allergies to any Neem based product or containing any of the other ingredients TheraNeem Lip Therapy: Organic Coconut Oil, Organic Beeswax, Organic Jojoba Oil, Shea Butter, Sesame Oil, Organic Neem Oil, , Essential Oil of Peppermint, Vitamin E (Tocopherol)
3. Signs of disseminated HSV illness
4. History of use of oral or topical antiviral agents within 10 days of screening and/or at start of study visit
5. Pregnancy or lactation
6. Psychiatric disorder
7. Inability to understand or follow the instructions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00985335
Study Brief:
Protocol Section:
NCT00985335