ISRCTN03397663
Completed
Not 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 enrollmentJuly 5, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Herpes Simplex Labialis
- Sponsor
- BSP Pharma A/S (Denmark)
- Enrollment
- 160
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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