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Completed

NCT Number: NCT00860795

Immunologic Effects of Echinacea

The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea 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 the Echinacea will have evidence of immune stimulation and those receiving placebo will not.

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Key information

Conditions

Upper Respiratory Tract Infections Infections Respiratory Tract Diseases Respiratory Tract Infections

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 adults 21-65 years old
  • If female of child-bearing potential, willing to use contraception to prevent pregnancy
  • Speaks and reads English
  • No use of any medication (other than multivitamins, essential fatty acids or probiotics)
  • Willing to abstain from ingesting edible mushrooms throughout study
  • Willing to eat less than 2 garlic cloves per day throughout study

Exclusion criteria

  • Positive pregnancy test or currently breastfeeding
  • History of autoimmune disease
  • History of allergic rhinitis
  • History of physician diagnosed eczema
  • Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus)
  • Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A

Treatment and study plan

Echinacea purpurea

Biological

Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days

Placebo

Drug

placebo 25 ml daily in 2 divided doses for 10 days

Primary outcomes

  1. Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)

    Time frame: 10 days

    tumor necrosis factor alpha NK cells and evidence of CD25/69 activation

Secondary outcomes

  1. Maximal Levels of Interferon Alpha (pg/ml)

    Time frame: 10 days

    interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

  2. Maximal CD25/69 Activation (% of NK CD25/69+ Cells)

    Time frame: 10 days

    NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation

  3. Adverse Effects

    Time frame: 30 days

  4. Maximal Levels of Interleukin 2 (pg/ml)

    Time frame: 10 days

    interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

  5. Maximal Levels of Interleukin 6 (pg/ml)

    Time frame: 10 days

    interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

  6. Maximal Levels of Interleukin 12 (pg/ml)

    Time frame: 10 days

    interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Study of the Immunologic Effects of Echinacea Purpurea in Adults

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 12, 2009
Registry last updated
May 1, 2018

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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