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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
May 14, 2010
May 24, 2010
May 4, 2012
June 5, 2012
June 21, 2012
May 2010
March 2011   (Final data collection date for primary outcome measure)
Peak Level of TNF Alpha [ Time Frame: 1-10 days after starting study medication ]
Highest level of TNF alpha while taking study medication
Peak Level of TNF Alpha [ Time Frame: 1-10 days after starting study medication ]
Complete list of historical versions of study NCT01129128 on ClinicalTrials.gov Archive Site
  • 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
  • Peak levels of IL-2, IL-6, and interferon gamma [ Time Frame: 1-10 days after starting 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
Not Provided
Not Provided
 
Three Arm Trial of Immune Effects of Echinacea
3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Upper Respiratory Tract Infections
  • Biological: Echinacea purpurea product
    5 ml by mouth 3 times per day for 10 days
  • Biological: Echinacea purpurea product
    1 ml by mouth 3 times per day for 10 days
  • Biological: Placebo
    either 5 ml or 1 ml by mouth three times per day for 10 days
  • Active Comparator: Echinacea preparation 1
    Commercially available Echinacea purpurea product
    Intervention: Biological: Echinacea purpurea product
  • Active Comparator: Echinacea preparation 2
    Commercially available Echinacea purpurea product
    Intervention: Biological: Echinacea purpurea product
  • Placebo Comparator: Placebo
    Inert liquid that is similar in appearance and taste to the active Echinacea products
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01129128
10A1276
No
Not Provided
Not Provided
James Taylor, University of Washington
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: James A Taylor, MD University of Washington
University of Washington
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP