Trial record 6 of 8 for:    Echinacea | NCCAM

Immunologic Effects of Echinacea

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00860795
First received: March 10, 2009
Last updated: October 20, 2010
Last verified: October 2010
  Purpose

The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.


Condition Intervention
Upper Respiratory Tract Infections
Biological: Echinacea purpurea
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of the Immunologic Effects of Echinacea Purpurea in Adults

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    tumor necrosis factor alpha NK cells and evidence of CD25/69 activation


Secondary Outcome Measures:
  • Maximal Levels of Interferon Alpha (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

  • Maximal CD25/69 Activation (% of NK CD25/69+ Cells) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation

  • Adverse Effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Maximal Levels of Interleukin 2 (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

  • Maximal Levels of Interleukin 6 (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

  • Maximal Levels of Interleukin 12 (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.


Enrollment: 20
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Echinacea Biological: Echinacea purpurea
Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
Placebo Comparator: placebo Drug: placebo
placebo 25 ml daily in 2 divided doses for 10 days

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults 21-65 years old
  • If female of child-bearing potential, willing to use contraception to prevent pregnancy
  • Speaks and reads English
  • No use of any medication (other than multivitamins, essential fatty acids or probiotics)
  • Willing to abstain from ingesting edible mushrooms throughout study
  • Willing to eat less than 2 garlic cloves per day throughout study

Exclusion Criteria:

  • Positive pregnancy test or currently breastfeeding
  • History of autoimmune disease
  • History of allergic rhinitis
  • History of physician diagnosed eczema
  • Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus)
  • Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A
  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: NCT00860795

Locations
United States, Washington
Bastyr University
Kenmore, Washington, United States, 98028
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: James A Taylor, MD University of Washington
  More Information

No publications provided

Responsible Party: James A Taylor, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00860795     History of Changes
Other Study ID Numbers: 09A1236, 5U01AT002400
Study First Received: March 10, 2009
Results First Received: September 28, 2010
Last Updated: October 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Echinacea
prevention
immune modulation

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014