Back to resultsThree Arm Trial of Immune Effects of Echinacea
Primary Purpose
Upper Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echinacea purpurea product
Echinacea purpurea product
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Upper Respiratory Tract Infections focused on measuring Echinacea, immune modulation, prevention
Eligibility Criteria
Inclusion Criteria:
- Healthy adult (based on a screening health questionnaire)
- Speaks and reads English.
- If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study.
- No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study.
- Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study.
- Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period
Exclusion Criteria:
- Pregnancy or currently breastfeeding.
- History of autoimmune disease or immune disorders.
- History of asthma.
- History of allergic rhinitis.
- History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash.
- Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus).
- Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits
Sites / Locations
- Bastyr University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Echinacea preparation 1
Echinacea preparation 2
Placebo
Arm Description
Commercially available Echinacea purpurea product
Commercially available Echinacea purpurea product
Inert liquid that is similar in appearance and taste to the active Echinacea products
Outcomes
Primary Outcome Measures
Peak Level of TNF Alpha
Highest level of TNF alpha while taking study medication
Secondary Outcome Measures
Peak Level IL-6
Highest level of IL-6 while taking study medication
Peak Level Interferon Gamma
Highest level of Interferon gamma while taking study medication
Peak Level IL-2
Highest level of IL-2 while taking study medication
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared
Full Information
NCT ID
NCT01129128
First Posted
May 14, 2010
Last Updated
June 14, 2012
Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01129128
Brief Title
Three Arm Trial of Immune Effects of Echinacea
Official Title
3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to determine if either of two, commercially available, Echinacea purpurea products stimulate the immune system. For the study, 60 healthy adults will be randomized to receive one of the two Echinacea purpurea products 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 either of the Echinacea products will have evidence of immune stimulation and those receiving placebo will not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
Echinacea, immune modulation, prevention
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Echinacea preparation 1
Arm Type
Active Comparator
Arm Description
Commercially available Echinacea purpurea product
Arm Title
Echinacea preparation 2
Arm Type
Active Comparator
Arm Description
Commercially available Echinacea purpurea product
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inert liquid that is similar in appearance and taste to the active Echinacea products
Intervention Type
Biological
Intervention Name(s)
Echinacea purpurea product
Intervention Description
5 ml by mouth 3 times per day for 10 days
Intervention Type
Biological
Intervention Name(s)
Echinacea purpurea product
Intervention Description
1 ml by mouth 3 times per day for 10 days
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
either 5 ml or 1 ml by mouth three times per day for 10 days
Primary Outcome Measure Information:
Title
Peak Level of TNF Alpha
Description
Highest level of TNF alpha while taking study medication
Time Frame
1-10 days after starting study medication
Secondary Outcome Measure Information:
Title
Peak Level IL-6
Description
Highest level of IL-6 while taking study medication
Time Frame
1-10 days after starting study medication
Title
Peak Level Interferon Gamma
Description
Highest level of Interferon gamma while taking study medication
Time Frame
1-10 days after starting study medication
Title
Peak Level IL-2
Description
Highest level of IL-2 while taking study medication
Time Frame
1-10 days after starting study medication
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared
Time Frame
1- 30 days after starting study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult (based on a screening health questionnaire)
Speaks and reads English.
If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study.
No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study.
Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study.
Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period
Exclusion Criteria:
Pregnancy or currently breastfeeding.
History of autoimmune disease or immune disorders.
History of asthma.
History of allergic rhinitis.
History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash.
Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus).
Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Taylor, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bastyr University
City
Kenmore
State/Province
Washington
ZIP/Postal Code
98028
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Three Arm Trial of Immune Effects of Echinacea
We'll reach out to this number within 24 hrs