Immunologic Effects of Echinacea

Upper Respiratory Tract Infections Clinical Trial

Official title:

Study of the Immunologic Effects of Echinacea Purpurea in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860795
• Other study ID #: 09A1236
• Secondary ID: 5U01AT002400
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: August 2009

Study information

• Verified date: April 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

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

Drug:
• placebo
placebo 25 ml daily in 2 divided doses for 10 days

Locations

Country	Name	City	State
United States	Bastyr University	Kenmore	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)	tumor necrosis factor alpha NK cells and evidence of CD25/69 activation	10 days
Secondary	Maximal Levels of Interferon Alpha (pg/ml)	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.	10 days
Secondary	Maximal CD25/69 Activation (% of NK CD25/69+ Cells)	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	10 days
Secondary	Adverse Effects		30 days
Secondary	Maximal Levels of Interleukin 2 (pg/ml)	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.	10 days
Secondary	Maximal Levels of Interleukin 6 (pg/ml)	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.	10 days
Secondary	Maximal Levels of Interleukin 12 (pg/ml)	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.	10 days