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Immunologic Effects of Echinacea

Primary Purpose

Upper Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echinacea purpurea
placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Upper Respiratory Tract Infections focused on measuring Echinacea, prevention, immune modulation

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bastyr University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Echinacea

placebo

Arm Description

Outcomes

Primary Outcome Measures

Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation

Secondary Outcome Measures

Maximal Levels of Interferon Alpha (pg/ml)
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)
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
Maximal Levels of Interleukin 2 (pg/ml)
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)
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)
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.

Full Information

First Posted
March 10, 2009
Last Updated
April 29, 2018
Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00860795
Brief Title
Immunologic Effects of Echinacea
Official Title
Study of the Immunologic Effects of Echinacea Purpurea in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
Echinacea, prevention, immune modulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echinacea
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Echinacea purpurea
Intervention Description
Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo 25 ml daily in 2 divided doses for 10 days
Primary Outcome Measure Information:
Title
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
Description
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Maximal Levels of Interferon Alpha (pg/ml)
Description
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.
Time Frame
10 days
Title
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
Description
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
Time Frame
10 days
Title
Adverse Effects
Time Frame
30 days
Title
Maximal Levels of Interleukin 2 (pg/ml)
Description
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.
Time Frame
10 days
Title
Maximal Levels of Interleukin 6 (pg/ml)
Description
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.
Time Frame
10 days
Title
Maximal Levels of Interleukin 12 (pg/ml)
Description
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.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Taylor, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bastyr University
City
Kenmore
State/Province
Washington
ZIP/Postal Code
98028
Country
United States

12. IPD Sharing Statement

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Immunologic Effects of Echinacea

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