Clinical trial NCT01129128: Three Arm Trial of Immune Effects of Echinacea
Official title: 3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Keywords: Echinacea
immune modulation
prevention
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-05-24
Enrollment: 67
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak Level of TNF Alpha
timeFrame: 1-10 days after starting study medication
Secondary outcomes:
measure: Peak Level IL-6
timeFrame: 1-10 days after starting study medication
measure: Peak Level Interferon Gamma
timeFrame: 1-10 days after starting study medication
measure: Peak Level IL-2
timeFrame: 1-10 days after starting study medication
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1- 30 days after starting study medication
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: University of Washington
name: James A Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: