Back to resultsEvaluation of Atuna Racemosa Toxicity
Primary Purpose
Bacterial Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atuna Racemosa
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Infections
Eligibility Criteria
The subjects will be 20 healthy male and non-pregnant, non-lactating, female volunteers of ages 18 - 65. No subject will be excluded based on minority status.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00318344
Brief Title
Evaluation of Atuna Racemosa Toxicity
Official Title
Evaluation of Atuna Racemosa Toxicity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
5. Study Description
Brief Summary
For thousands of years people in the South Pacific have used Atuna racemosa extract as a topical anti-inflammatory. We, the researchers at the Mayo Clinic, have shown this extract to also have antibacterial properties. While this extract has been used for decades in the South Pacific, a controlled clinical trial to evaluate toxicity has never been performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atuna Racemosa
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The subjects will be 20 healthy male and non-pregnant, non-lactating, female volunteers of ages 18 - 65. No subject will be excluded based on minority status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J. Buenz
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Atuna Racemosa Toxicity
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