Immunologic Effects of Echinacea

Study of the Immunologic Effects of Echinacea Purpurea in Adults

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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infections
• Intervention / Treatment: Biological: Echinacea purpurea; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kenmore, Washington, United States, 98028
      • Bastyr University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; placebo 25 ml daily in 2 divided doses for 10 days
Active Comparator: Echinacea	Biological: Echinacea purpurea; Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)	tumor necrosis factor alpha NK cells and evidence of CD25/69 activation	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Effects		30 days
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.	10 days
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	10 days
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.	10 days
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.	10 days
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.	10 days

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 11, 2009
• First Posted (Estimate): March 12, 2009

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: prevention; immune modulation; Echinacea
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 09A1236; 5U01AT002400 (U.S. NIH Grant/Contract)