search
Back to results

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

Primary Purpose

Herpes Simplex

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neem Based External Application Cream
Sponsored by
Southern California University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern California University of Health Science

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

External Application of Neem-based Cream

Arm Description

Non Controlled, non-randomized, single group pilot study.

Outcomes

Primary Outcome Measures

Cold Sore Symptom Scale

Secondary Outcome Measures

Full Information

First Posted
August 28, 2009
Last Updated
November 16, 2011
Sponsor
Southern California University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00985335
Brief Title
Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis
Acronym
Neem
Official Title
Effectiveness of TheraNeem Lip Therapy of Common Symptoms of Herpes Simplex Labialis A Prospective Experimental Case Series (n=5)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Application of Neem-based Cream
Arm Type
Experimental
Arm Description
Non Controlled, non-randomized, single group pilot study.
Intervention Type
Other
Intervention Name(s)
Neem Based External Application Cream
Intervention Description
Apply externally 3-4 times per day
Primary Outcome Measure Information:
Title
Cold Sore Symptom Scale
Time Frame
Baseline and End of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melany Meier, DC
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sivarama Vinjamury, L.Ac
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California University of Health Science
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

We'll reach out to this number within 24 hrs