Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

This study has been completed.

First Received on August 28, 2009. Last Updated on November 16, 2011 History of Changes

Sponsor:	Southern California University of Health Sciences
Information provided by (Responsible Party):	Sivarama Vinjamury, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:	NCT00985335

Purpose

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.

Condition	Intervention	Phase
Herpes Simplex	Other: Neem Based External Application Cream	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effectiveness of TheraNeem Lip Therapy of Common Symptoms of Herpes Simplex Labialis A Prospective Experimental Case Series (n=5)

Resource links provided by NLM:

MedlinePlus related topics: Cold Sores Herpes Simplex

U.S. FDA Resources

Further study details as provided by Southern California University of Health Sciences:

Primary Outcome Measures:

Cold Sore Symptom Scale [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	August 2009
Study Completion Date:	March 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: External Application of Neem-based Cream Non Controlled, non-randomized, single group pilot study.	Other: Neem Based External Application Cream Apply externally 3-4 times per day

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participant has signs and symptoms of HSV-1 infection of less than 24 hours duration to the Southern California University of Health Sciences investigators
Participants ages 18-70 years
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
Subjects expressed willingness to comply with protocol
Subject will be willing to have the presenting lesion photographed twice
Subject sign a written informed consent, HIPPA disclosure, Experimental bill of rights

Exclusion Criteria:

History of past or present immunosuppressive condition, or currently taking immunosuppressive medication
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)
Signs of disseminated HSV illness
History of use of oral or topical antiviral agents within 10 days of screening and/or at start of study visit
Pregnancy or lactation
Psychiatric disorder
Inability to understand or follow the instructions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985335

Locations

United States, California
Southern California University of Health Science
Whittier, California, United States, 90604

Sponsors and Collaborators

Southern California University of Health Sciences

Investigators

Principal Investigator:	Melany Meier, DC	Southern California University of Health Sciences
Principal Investigator:	Sivarama Vinjamury, L.Ac	Southern California University of Health Sciences

More Information

No publications provided

Responsible Party:	Sivarama Vinjamury, Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:	NCT00985335 History of Changes
Other Study ID Numbers:	SCU-09-VINJ004
Study First Received:	August 28, 2009
Last Updated:	November 16, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral

Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012