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Completed

NCT Number: NCT01129128

Three Arm Trial of Immune Effects of Echinacea

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bastyr University

Kenmore, Washington, 98028, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echinacea purpurea product

Biological

5 ml by mouth 3 times per day for 10 days

Placebo

Biological

either 5 ml or 1 ml by mouth three times per day for 10 days

Primary outcomes

  1. Peak Level of TNF Alpha

    Time frame: 1-10 days after starting study medication

    Highest level of TNF alpha while taking study medication

Secondary outcomes

  1. Peak Level IL-6

    Time frame: 1-10 days after starting study medication

    Highest level of IL-6 while taking study medication

  2. Peak Level Interferon Gamma

    Time frame: 1-10 days after starting study medication

    Highest level of Interferon gamma while taking study medication

  3. Peak Level IL-2

    Time frame: 1-10 days after starting study medication

    Highest level of IL-2 while taking study medication

  4. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 24, 2010
Registry last updated
Jun 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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