Effects of Echinacea in Children

November 30, 2015 updated by: James Taylor, University of Washington

Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TNF levels
Time Frame: During first course of study medication
During first course of study medication

Secondary Outcome Measures

Outcome Measure
Time Frame
CD25/CD69 activation
Time Frame: 120 days
120 days
IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels
Time Frame: 120 days
120 days
specific and general adverse events
Time Frame: 120 days
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

May 1, 2009

Study Completion (ANTICIPATED)

August 1, 2009

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (ESTIMATE)

October 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A41256
  • 5U01AT002400 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Upper Respiratory Infections

Clinical Trials on Echinacea purpurea 100 mg/ml in liquid formulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe