Three Arm Trial of Immune Effects of Echinacea

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 67
• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: May 14, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (ESTIMATE): May 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: June 1, 2012

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: 10A1276