Back to resultsEffects of Echinacea in Children
Primary Purpose
Upper Respiratory Infections
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Echinacea purpurea 100 mg/ml in liquid formulation
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Upper Respiratory Infections focused on measuring Upper respiratory tract infections, Children, Echinacea, Prevention, Immune modulation
Eligibility Criteria
Inclusion Criteria:
- Healthy children 6-11 years old
- Parent/Caregiver who can read and speak English
- One child per family
Exclusion Criteria:
- History of allergic reaction to Echinacea or related species
- History of asthma
- History of allergic rhinitis
- History of autoimmune disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1. Echinacea purpurea
2. placebo
Arm Description
Outcomes
Primary Outcome Measures
TNF levels
Secondary Outcome Measures
CD25/CD69 activation
IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels
specific and general adverse events
Full Information
NCT ID
NCT00773435
First Posted
October 14, 2008
Last Updated
November 30, 2015
Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00773435
Brief Title
Effects of Echinacea in Children
Official Title
Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Withdrawn
Why Stopped
Decided to conduct study in adults first
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)
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
Yes
5. Study Description
Brief Summary
The goal of the this study is to determine if Echinacea purpurea stimulates the immune system in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be obtained in the children just before starting study medication, during the first course of medication and either just prior to starting the second course of medication or 50 days following the last of the three courses of medication. Markers of immune activity in children receiving Echinacea or placebo will be compared.
Detailed Description
This is an application to study the biologic activity of a specific formulation of Echinacea purpurea in children 6-11 years old. The goal of the study is to determine if Echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (TNF), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (IL-2, IL-6, and IL-12), as well CD25 and CD69 activation. A total of 40 study children will be randomized to receive either the Echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. Blood samples will be obtained at baseline, at the time of "peak" TNF activity, and either 30 or 120 days after beginning the study medication. Prior to beginning this pediatric study "peak" TNF activity will be determined by administering the Echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. If it is demonstrated that this formulation of E purpurea has biologic activity, a large randomized controlled trial is planned to determine if E purpurea can prevent upper respiratory tract infection (URI) in children 2-11 years old.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Infections
Keywords
Upper respiratory tract infections, Children, Echinacea, Prevention, Immune modulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Echinacea purpurea
Arm Type
Active Comparator
Arm Title
2. placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Echinacea purpurea 100 mg/ml in liquid formulation
Intervention Description
10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods
Primary Outcome Measure Information:
Title
TNF levels
Time Frame
During first course of study medication
Secondary Outcome Measure Information:
Title
CD25/CD69 activation
Time Frame
120 days
Title
IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels
Time Frame
120 days
Title
specific and general adverse events
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy children 6-11 years old
Parent/Caregiver who can read and speak English
One child per family
Exclusion Criteria:
History of allergic reaction to Echinacea or related species
History of asthma
History of allergic rhinitis
History of autoimmune disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Taylor
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of Echinacea in Children
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