Three Arm Trial of Immune Effects of Echinacea

University of Washington

Status: Completed

Conditions: Upper Respiratory Tract Infections

Treatments: Biological: Placebo; Biological: Echinacea purpurea product

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01129128

10A1276

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 3 patient groups, including a placebo group

Echinacea preparation 1

Active Comparator group

Description:

Commercially available Echinacea purpurea product

Treatment:

Biological: Echinacea purpurea product

Biological: Echinacea purpurea product

Echinacea preparation 2

Active Comparator group

Description:

Commercially available Echinacea purpurea product

Treatment:

Biological: Echinacea purpurea product

Biological: Echinacea purpurea product

Placebo

Placebo Comparator group

Description:

Inert liquid that is similar in appearance and taste to the active Echinacea products

Treatment:

Biological: Placebo