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CompletedNCT00985335NeemUpdated Nov 18, 2011

Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

A Phase 1 interventional study of Neem Based External Application Cream in Herpes Simplex, sponsored by Southern California University of Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-11-18.

Sponsored by Southern California University of Health Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Herpes Simplex
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 5 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Southern California University of Health Sciences is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    External Application of Neem-based Cream

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

    Other: Neem Based External Application Cream

Interventions

  • OtherNeem Based External Application Cream

    Apply externally 3-4 times per day

06

What researchers measure

Primary outcomes

  1. Cold Sore Symptom Scale

    Time frame: Baseline and End of Treatment

07

Study locations

1 site
  • Southern California University of Health Science
    Whittier, California 90604, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00985335
Lead sponsor
Southern California University of Health Sciences
Responsible party
Sivarama Vinjamury (Professor, Southern California University of Health Sciences) — Principal investigator
First posted
Sep 28, 2009
Start date
Aug 2009
Primary completion
Feb 2011
Completion
Mar 2011
Last update
Nov 18, 2011

Study contacts

Melany Meier, DC
principal investigator · Southern California University of Health Sciences
Sivarama Vinjamury, L.Ac
principal investigator · Southern California University of Health Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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