Effectiveness of TheraNeem Lip Therapy for Herpes Simplex... | NCT00985335

Studies
Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

NCT00985335

Sponsor

Southern California University of Health Sciences

Status

Completed

Last Update Posted

Nov 18, 2011Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Herpes Simplex

Interventions

Neem Based External Application Cream

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Aug 28, 2009

First Submission Date that Met QC Criteria

Sep 25, 2009

First Posted Date

Sep 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2011

Last Update Posted Date

Nov 18, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
External Application of Neem-based Cream	Experimental	Non Controlled, non-randomized, single group pilot study.	Other: Neem Based External Application Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neem Based External Application Cream	Other	Apply externally 3-4 times per day	External Application of Neem-based Cream

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern California University of Health Science		Whittier	California	90604	United States

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections