Three Arm Trial of Immune Effects of Echinacea

Study Overview
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Brief Summary
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The goal of this study is to determine if either of two, commercially available, Echinacea purpurea products stimulate the immune system. For the study, 60 healthy adults will be randomized to receive one of the two Echinacea purpurea products 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 either of the Echinacea products will have evidence of immune stimulation and those receiving placebo will not.

Official Title
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3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults

Conditions
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Upper Respiratory Tract Infections

Intervention / Treatment
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* Biological: Echinacea purpurea product
* Biological: Echinacea purpurea product
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult (based on a screening health questionnaire) Speaks and reads English. If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study. No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study. Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study. Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period Exclusion Criteria: Pregnancy or currently breastfeeding. History of autoimmune disease or immune disorders. History of asthma. History of allergic rhinitis. History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash. Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus). Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Echinacea preparation 1<br>Commercially available Echinacea purpurea product | Biological: Echinacea purpurea product<br>* 5 ml by mouth 3 times per day for 10 days<br>|
| Active Comparator: Echinacea preparation 2<br>Commercially available Echinacea purpurea product | Biological: Echinacea purpurea product<br>* 1 ml by mouth 3 times per day for 10 days<br>|
| Placebo Comparator: Placebo<br>Inert liquid that is similar in appearance and taste to the active Echinacea products | Biological: Placebo<br>* either 5 ml or 1 ml by mouth three times per day for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Level of TNF Alpha | Highest level of TNF alpha while taking study medication | 1-10 days after starting study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Level IL-6 | Highest level of IL-6 while taking study medication | 1-10 days after starting study medication | 
| Peak Level Interferon Gamma | Highest level of Interferon gamma while taking study medication | 1-10 days after starting study medication | 
| Peak Level IL-2 | Highest level of IL-2 while taking study medication | 1-10 days after starting study medication | 
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared | 1- 30 days after starting study medication | 

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