Effects of Echinacea in Children

Upper Respiratory Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00773435
• Other study ID #: A41256
• Secondary ID: 5U01AT002400
• Status: Withdrawn
• Phase: N/A
• First received: October 14, 2008
• Last updated: November 30, 2015
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: December 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Infections

Intervention

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

Other:
• placebo
10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Complementary and Integrative Health (NCCIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNF levels		During first course of study medication	No
Secondary	CD25/CD69 activation		120 days	No
Secondary	IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels		120 days	No
Secondary	specific and general adverse events		120 days	Yes