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Trial record 5 of 27 for:    Echinacea

Immunologic Effects of Echinacea

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ClinicalTrials.gov Identifier: NCT00860795
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : November 17, 2010
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
James Taylor, University of Washington

Tracking Information
First Submitted Date  ICMJE March 10, 2009
First Posted Date  ICMJE March 12, 2009
Results First Submitted Date  ICMJE September 28, 2010
Results First Posted Date  ICMJE November 17, 2010
Last Update Posted Date May 1, 2018
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
Maximal level of tumor necrosis factor alpha [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT00860795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
  • maximal levels of interferon alpha, interferon gamma, interleukins 2,6,12 [ Time Frame: 30 days ]
  • CD25/69 activation [ Time Frame: 30 days ]
  • Adverse Effects [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunologic Effects of Echinacea
Official Title  ICMJE Study of the Immunologic Effects of Echinacea Purpurea in Adults
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Upper Respiratory Tract Infections
Intervention  ICMJE
  • Biological: Echinacea purpurea
    Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
  • Drug: placebo
    placebo 25 ml daily in 2 divided doses for 10 days
Study Arms  ICMJE
  • Active Comparator: Echinacea
    Intervention: Biological: Echinacea purpurea
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00860795
Other Study ID Numbers  ICMJE 09A1236
5U01AT002400 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Taylor, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: James A Taylor, MD University of Washington
PRS Account University of Washington
Verification Date April 2018

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