Immunologic Effects of Echinacea

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infections
• Interventions: Biological: Echinacea purpurea; Drug: placebo

• Registration Number: NCT00860795
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-09-28
• Results First Submitted QC: 2010-10-20
• Results First Posted: 2010-11-17
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-29
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Echinacea	Echinacea purpurea	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)	10 days	tumor necrosis factor alpha NK cells and evidence of CD25/69 activation

Secondary Outcome Measures

Name	Time	Method
Maximal Levels of Interferon Alpha (pg/ml)	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.
Maximal Levels of Interleukin 6 (pg/ml)	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.
Maximal Levels of Interleukin 12 (pg/ml)	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.
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)	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
Adverse Effects	30 days
Maximal Levels of Interleukin 2 (pg/ml)	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.

Trial Locations

Locations (1)

Bastyr University; 🇺🇸 Kenmore, Washington, United States