Evaluation of Atuna Racemosa Toxicity

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00318344
First received: April 24, 2006
Last updated: February 1, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Drug: Atuna Racemosa
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Atuna Racemosa Toxicity

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 20
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  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: NCT00318344

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Eric J. Buenz Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00318344     History of Changes
Other Study ID Numbers: 170-06
Study First Received: April 24, 2006
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on July 28, 2014