Evaluation of Atuna Racemosa Toxicity

NCT ID: NCT00318344

Last Updated: 2010-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-11-30

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.

Conditions

Bacterial Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Atuna Racemosa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

The subjects will be 20 healthy male and non-pregnant, non-lactating, female volunteers of ages 18 - 65.

Exclusion Criteria

No subject will be excluded based on minority status.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Eric J. Buenz

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

170-06

Identifier Type: -

Identifier Source: org_study_id