Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sivarama Vinjamury, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00985335
First received: August 28, 2009
Last updated: November 16, 2011
Last verified: November 2011

August 28, 2009
November 16, 2011
August 2009
February 2011   (final data collection date for primary outcome measure)
Cold Sore Symptom Scale [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00985335 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis
Effectiveness of TheraNeem Lip Therapy of Common Symptoms of Herpes Simplex Labialis A Prospective Experimental Case Series (n=5)

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Herpes Simplex
Other: Neem Based External Application Cream
Apply externally 3-4 times per day
Experimental: External Application of Neem-based Cream
Non Controlled, non-randomized, single group pilot study.
Intervention: Other: Neem Based External Application Cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
March 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00985335
SCU-09-VINJ004
No
Sivarama Vinjamury, Southern California University of Health Sciences
Southern California University of Health Sciences
Not Provided
Principal Investigator: Melany Meier, DC Southern California University of Health Sciences
Principal Investigator: Sivarama Vinjamury, L.Ac Southern California University of Health Sciences
Southern California University of Health Sciences
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP