Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

NCT00985335 | Completed Phase 1

• 1 other identifier: SCU-09-VINJ004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Simplex

Outcome Measures

Primary Outcomes (1)

• Cold Sore Symptom Scale

  Baseline and End of Treatment

Study Arms (1)

External Application of Neem-based Cream

EXPERIMENTAL

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

Other: Neem Based External Application Cream

Interventions

Neem Based External Application Cream OTHER

Apply externally 3-4 times per day

External Application of Neem-based Cream

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern California University of Health Sciences: lead

Study Sites (1)

Southern California University of Health Science

Whittier, California, 90604, United States

Location

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Melany Meier, DC

  Southern California University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Sivarama Vinjamury, L.Ac

  Southern California University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: September 28, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 18, 2011

Record last verified: 2011-11

Locations

US (1)