Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

Herpes Simplex Clinical Trial

— Neem  

Official title:

Effectiveness of TheraNeem Lip Therapy of Common Symptoms of Herpes Simplex Labialis A Prospective Experimental Case Series (n=5)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985335
• Other study ID #: SCU-09-VINJ004
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2009
• Last updated: November 16, 2011
• Start date: August 2009
• Est. completion date: March 2011

Study information

• Verified date: November 2011
• Source: Southern California University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study intends to test the efficacy of the TheraNeem Lip Therapy balm for Herpes Simplex. The study will include a total of 5 people.

Description:

Qualified candidates will be officially enrolled into the study within 24 hours of their subsequent outbreak of Herpes Simplex Labialis. They will be given all of the Neem Therapy products to use, and photographs and questionnaires will be taken to assess their progress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis
• Herpes Simplex

Intervention

Other:
• Neem Based External Application Cream
Apply externally 3-4 times per day

Locations

Country	Name	City	State
United States	Southern California University of Health Science	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold Sore Symptom Scale		Baseline and End of Treatment	No