Skip to main content
OpenTrials
Completed

NCT Number: NCT00985335

Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Southern California University of Health Science

Whittier, California, 90604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neem Based External Application Cream

Other

Apply externally 3-4 times per day

Primary outcomes

  1. Cold Sore Symptom Scale

    Time frame: Baseline and End of Treatment

Sponsors and collaborators

Lead sponsor

Southern California University of Health Sciences

Other

Registry information

Official study title

Effectiveness of TheraNeem Lip Therapy of Common Symptoms of Herpes Simplex Labialis A Prospective Experimental Case Series (n=5)

Acronym: Neem

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2009
Registry last updated
Nov 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.