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Immunologic Effects of Echinacea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860795
First Posted: March 12, 2009
Last Update Posted: November 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
University of Washington
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    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 ]
  • Maximal Levels of Interleukin 2 (pg/ml) [ Time Frame: 10 days ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860795


Locations
United States, Washington
Bastyr University
Kenmore, Washington, United States, 98028
Sponsors and Collaborators
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: James A Taylor, MD University of Washington
  More Information

Responsible Party: James A Taylor, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00860795     History of Changes
Other Study ID Numbers: 09A1236
5U01AT002400 ( U.S. NIH Grant/Contract )
First Submitted: March 10, 2009
First Posted: March 12, 2009
Results First Submitted: September 28, 2010
Results First Posted: November 17, 2010
Last Update Posted: November 17, 2010
Last Verified: October 2010

Keywords provided by University of Washington:
Echinacea
prevention
immune modulation

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