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Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

NCT ID: NCT00985335

Last Updated: 2011-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Herpes Simplex

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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External Application of Neem-based Cream

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

Group Type EXPERIMENTAL

Neem Based External Application Cream

Intervention Type OTHER

Apply externally 3-4 times per day

Interventions

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Neem Based External Application Cream

Apply externally 3-4 times per day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern California University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sivarama Vinjamury

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melany Meier, DC

Role: PRINCIPAL_INVESTIGATOR

Southern California University of Health Sciences

Sivarama Vinjamury, L.Ac

Role: PRINCIPAL_INVESTIGATOR

Southern California University of Health Sciences

Locations

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Southern California University of Health Science

Whittier, California, United States

Site Status

Countries

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United States

Other Identifiers

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SCU-09-VINJ004

Identifier Type: -

Identifier Source: org_study_id