Immunologic Effects of Echinacea

• ClinicalTrials.gov Identifier: NCT00860795
• Recruitment Status: Completed
• First Posted: March 12, 2009
• Results First Posted: November 17, 2010
• Last Update Posted: May 1, 2018
• Sponsor: University of Washington
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): James Taylor, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Upper Respiratory Tract Infections	Biological: Echinacea purpurea; Drug: placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Study of the Immunologic Effects of Echinacea Purpurea in Adults
• Study Start Date: March 2009
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Echinacea	Biological: Echinacea purpurea; Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
Placebo Comparator: placebo	Drug: placebo; placebo 25 ml daily in 2 divided doses for 10 days

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Washington

Bastyr University

Kenmore, Washington, United States, 98028

Sponsors and Collaborators

University of Washington

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: James A Taylor, MD; University of Washington

More Information

• Responsible Party: James Taylor, School of Medicine: Pediatrics, University of Washington
• ClinicalTrials.gov Identifier: NCT00860795
• Other Study ID Numbers: 09A1236; 5U01AT002400 ( U.S. NIH Grant/Contract )
• First Posted: March 12, 2009
• Results First Posted: November 17, 2010
• Last Update Posted: May 1, 2018
• Last Verified: April 2018

Keywords provided by James Taylor, University of Washington:

Echinacea; prevention; immune modulation

Additional relevant MeSH terms:

Respiratory Tract Infections; Infections; Respiratory Tract Diseases