ISRCTN03397663CompletedNot Applicable
Evaluation of the efficacy and safety of a Sheabutter extract on cold sores (herpes simplex labialis)
BSP Pharma A/S (Denmark)0 sites160 target enrollmentStarted: July 5, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects aged 18 and 75 years, in good general health who have a clinical history of recurrent herpes labialis, with at least six self reported episodes of herpes lesion in the past year and at least one recurrance every three months.
Exclusion Criteria
- •1. History of immunodeficiency
- •2. Use of other antiviral agents (including herbal medications), anti-inflammatory medications, steroids or analgesics during the treatment period
- •3. Known allergy to Sheabutter
- •4. Liver function tests greater than 3 times the upper limit of normal at baseline
- •5. Female participants who are lactating, pregnant or planning to become pregnant
- •6. Participants who have participated in another clinical trial in the last 30 days
- •7. Participants unwilling to comply with the study protocol
- •8. Any other condition, which in the opinion of the investigators could compromise the study
Investigators
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