Hsv 1 and 2 Gowey Protocol Versus Placebo
This study has been completed.
Sponsor:
Naturopaths International
Information provided by (Responsible Party):
Dr. Brandie Gowey, NMD, Naturopaths International
ClinicalTrials.gov Identifier:
NCT01477879
First received: November 15, 2011
Last updated: November 19, 2011
Last verified: November 2011
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Purpose
This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes |
Other: Versabase gel with sarracenia purpurea 20% liquid extract Other: placebo (versabase gel only) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Trial of Versabase/Sarracenia Purpurea Versus Placebo |
Further study details as provided by Naturopaths International:
Primary Outcome Measures:
- Pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Pain scale-- subjective
- Size [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Measure lesion size over 2 weeks
Secondary Outcome Measures:
- Appearance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Photo taken of lesion w patient informed consent
| Enrollment: | 33 |
| Study Start Date: | January 2011 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Versabase/20% S. purpurea extract |
Other: Versabase gel with sarracenia purpurea 20% liquid extract
Topical application of gel/plant mix to lesions
|
|
Placebo Comparator: placebo (versabase gel only)
placebo used will be versabase gel alone
|
Other: placebo (versabase gel only)
versabase gel only
|
Detailed Description:
Patients screened for hsv one or two. Patients with herpes given a 1/8 oz of gel. Researcher does not know which is active and which is placebo (placebo is actually just versabase gel). Patent applies gel to lesions every 3-4 hours. Returns to clinic on days 3, 5, and 14 for evaluation. Up to 50 patients may be enrolled.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Hsv 1&2
Exclusion Criteria:
- No active lesions
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Brandie Gowey, NMD, Brandie Gowey, Naturopaths International |
| ClinicalTrials.gov Identifier: | NCT01477879 History of Changes |
| Other Study ID Numbers: | HSV1&2 |
| Study First Received: | November 15, 2011 |
| Last Updated: | November 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013