Immunologic Effects of Echinacea

University of Washington20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Upper Respiratory Tract Infections

Interventions

Echinacea purpureaBIOLOGICAL

Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days

placeboDRUG

placebo 25 ml daily in 2 divided doses for 10 days

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bastyr University

Kenmore, Washington, United States

Outcomes

Primary Outcomes

Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)

tumor necrosis factor alpha NK cells and evidence of CD25/69 activation

Time frame: 10 days

Secondary Outcomes

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.

Time frame: 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

Time frame: 10 days

Adverse Effects

Time frame: 30 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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