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Three Arm Trial of Immune Effects of Echinacea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129128
First Posted: May 24, 2010
Last Update Posted: June 21, 2012
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 (Responsible Party):
James Taylor, University of Washington
  Purpose
The goal of this study is to determine if either of two, commercially available, Echinacea purpurea products stimulate the immune system. For the study, 60 healthy adults will be randomized to receive one of the two Echinacea purpurea products 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 either of the Echinacea products will have evidence of immune stimulation and those receiving placebo will not.

Condition Intervention
Upper Respiratory Tract Infections Biological: Echinacea purpurea product Biological: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults

Resource links provided by NLM:


Further study details as provided by James Taylor, University of Washington:

Primary Outcome Measures:
  • Peak Level of TNF Alpha [ Time Frame: 1-10 days after starting study medication ]
    Highest level of TNF alpha while taking study medication


Secondary Outcome Measures:
  • Peak Level IL-6 [ Time Frame: 1-10 days after starting study medication ]
    Highest level of IL-6 while taking study medication

  • Peak Level Interferon Gamma [ Time Frame: 1-10 days after starting study medication ]
    Highest level of Interferon gamma while taking study medication

  • Peak Level IL-2 [ Time Frame: 1-10 days after starting study medication ]
    Highest level of IL-2 while taking study medication

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1- 30 days after starting study medication ]
    Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared


Enrollment: 67
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Echinacea preparation 1
Commercially available Echinacea purpurea product
Biological: Echinacea purpurea product
5 ml by mouth 3 times per day for 10 days
Active Comparator: Echinacea preparation 2
Commercially available Echinacea purpurea product
Biological: Echinacea purpurea product
1 ml by mouth 3 times per day for 10 days
Placebo Comparator: Placebo
Inert liquid that is similar in appearance and taste to the active Echinacea products
Biological: Placebo
either 5 ml or 1 ml by mouth three times per day 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 adult (based on a screening health questionnaire)
  • Speaks and reads English.
  • If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study.
  • No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study.
  • Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study.
  • Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period

Exclusion Criteria:

  • Pregnancy or currently breastfeeding.
  • History of autoimmune disease or immune disorders.
  • History of asthma.
  • History of allergic rhinitis.
  • History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash.
  • Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus).
  • Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits
  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): NCT01129128


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 Taylor, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01129128     History of Changes
Other Study ID Numbers: 10A1276
First Submitted: May 14, 2010
First Posted: May 24, 2010
Results First Submitted: May 4, 2012
Results First Posted: June 5, 2012
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by James Taylor, University of Washington:
Echinacea
immune modulation
prevention

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