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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014