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Effects of Echinacea in Children

This study has been withdrawn prior to enrollment.
(Decided to conduct study in adults first)
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00773435
First received: October 14, 2008
Last updated: December 10, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention
Upper Respiratory Infections
 Biological: Echinacea purpurea 100 mg/ml in liquid formulation
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children

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:
  • TNF levels [ Time Frame: During first course of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD25/CD69 activation [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • specific and general adverse events [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Echinacea purpurea Biological: Echinacea purpurea 100 mg/ml in liquid formulation
10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods
Placebo Comparator: 2. placebo Other: placebo
10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods

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.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773435

Sponsors and Collaborators
University of Washington
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: James A Taylor University of Washington
  More Information

No publications provided

Responsible Party: James A. Taylor, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00773435     History of Changes
Other Study ID Numbers: A41256, 5U01AT002400
Study First Received: October 14, 2008
Last Updated: December 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Upper respiratory tract infections
Children
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