Three Arm Trial of Immune Effects of Echinacea

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infections
• Interventions: Biological: Echinacea purpurea product; Biological: Placebo

• Registration Number: NCT01129128
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-24
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-05-04
• Results First Submitted QC: 2012-05-04
• Status Verified: 2012-06
• Results First Posted: 2012-06-05
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Echinacea preparation 1	Echinacea purpurea product	Commercially available Echinacea purpurea product
Echinacea preparation 2	Echinacea purpurea product	Commercially available Echinacea purpurea product
Placebo	Placebo	Inert liquid that is similar in appearance and taste to the active Echinacea products

Primary Outcome Measures

Name	Time	Method
Peak Level of TNF Alpha	1-10 days after starting study medication	Highest level of TNF alpha while taking study medication

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bastyr University; 🇺🇸 Kenmore, Washington, United States