Immunologic Effects of Echinacea

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Immunologic Effects of Echinacea Purpurea in Adults

Conditions
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Upper Respiratory Tract Infections

Intervention / Treatment
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* Biological: Echinacea purpurea
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Adverse Effects |  | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echinacea, prevention, immune modulation