Hsv 1 and 2 Gowey Protocol Versus Placebo

This study has been completed.
Sponsor:
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
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477879

Locations
United States, Arizona
Naturopaths international
Flagstaff, Arizona, United States, 86001
Sponsors and Collaborators
Naturopaths International
  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 April 15, 2014