- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01477879
Hsv 1 and 2 Gowey Protocol Versus Placebo
November 19, 2011 updated by: Dr. Brandie Gowey, NMD, Naturopaths International
Phase II Clinical Trial of Versabase/Sarracenia Purpurea Versus Placebo
This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Flagstaff, Arizona, United States, 86001
- Naturopaths international
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hsv 1&2
Exclusion Criteria:
- No active lesions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Versabase/20% S. purpurea extract
|
Topical application of gel/plant mix to lesions
|
Placebo Comparator: placebo (versabase gel only)
placebo used will be versabase gel alone
|
versabase gel only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 2 weeks
|
Pain scale-- subjective
|
2 weeks
|
Size
Time Frame: 2 weeks
|
Measure lesion size over 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appearance
Time Frame: 2 weeks
|
Photo taken of lesion w patient informed consent
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 15, 2011
First Submitted That Met QC Criteria
November 19, 2011
First Posted (Estimate)
November 23, 2011
Study Record Updates
Last Update Posted (Estimate)
November 23, 2011
Last Update Submitted That Met QC Criteria
November 19, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- HSV1&2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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