Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis (Neem)

November 16, 2011 updated by: Sivarama Vinjamury, Southern California University of Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cold Sore Symptom Scale
Time Frame: Baseline and End of Treatment
Baseline and End of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCU-09-VINJ004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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