Immunologic Effects of Echinacea
This study has been completed.
Sponsor:
University of Washington
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00860795
First received: March 10, 2009
Last updated: October 20, 2010
Last verified: October 2010
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Purpose
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 | Intervention |
|---|---|
|
Upper Respiratory Tract Infections |
Biological: Echinacea purpurea Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Study of the Immunologic Effects of Echinacea Purpurea in Adults |
Resource links provided by NLM:
MedlinePlus related topics:
Common Cold
Drug Information available for:
Echinacea
U.S. FDA Resources
Further study details as provided by University of Washington:
Primary Outcome Measures:
- Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Secondary Outcome Measures:
- Maximal Levels of Interferon Alpha (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]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 CD25/69 Activation (% of NK CD25/69+ Cells) [ Time Frame: 10 days ] [ Designated as safety issue: No ]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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Maximal Levels of Interleukin 2 (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]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.
- Maximal Levels of Interleukin 6 (pg/ml) [ Time Frame: 10 days ] [ Designated as safety issue: No ]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) [ Time Frame: 10 days ] [ Designated as safety issue: No ]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.
| Enrollment: | 20 |
| Study Start Date: | March 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860795
Locations
| United States, Washington | |
| Bastyr University | |
| Kenmore, Washington, United States, 98028 | |
Sponsors and Collaborators
University of Washington
Investigators
| Principal Investigator: | James A Taylor, MD | University of Washington |
More Information
No publications provided
| Responsible Party: | James A Taylor, MD, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00860795 History of Changes |
| Other Study ID Numbers: | 09A1236, 5U01AT002400 |
| Study First Received: | March 10, 2009 |
| Results First Received: | September 28, 2010 |
| Last Updated: | October 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Washington:
|
Echinacea prevention immune modulation |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Common Cold Infection Respiratory Tract Diseases |
Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013