Evaluation of Atuna Racemosa Toxicity

Bacterial Infections Clinical Trial

Official title:

Evaluation of Atuna Racemosa Toxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318344
• Other study ID #: 170-06
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2006
• Last updated: February 1, 2010
• Start date: April 2006
• Est. completion date: November 2007

Study information

• Verified date: February 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• Atuna Racemosa

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,