Echinaforce Junior Bioavailability Trial

Study Overview
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Brief Summary
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In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.

Detailed Description
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In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets. Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and thereafter the bioavailability is measured and calculated.

Official Title
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Bioavailability of an Echinacea Product (Echinaforce® Junior) in Children With a Common Cold, Aged 4-12 Years After Intake of a Daily Dosage

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Echinaforce junior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children in the age group 4-12 years with an uncomplicated common cold (upper respiratory tract infection) First symptoms appeared within the last 72 hours Written consent given by the parents and verbal consent of children who are capable of judgement Exclusion Criteria: Not able to fast 2 hours prior to the treatment intake of another preparation containing echinacea within the last 24 hours Participation in a clinical trial within the last 30 days any progressive systemic illness, including tuberculosis, leukemia, connective tissue diseases, multiple sclerosis, or other autoimmune diseases; or history of relevant allergy, including allergy to Compositae plants

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: The study participants take 5 tablets Echinaforce junior at once one after another per os. registered in Switzerland for children from age of 4 -12 years Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and then analyzed on the amount of tetraen. Bioavailability parameters will thereafter be calculated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echinaforce junior<br>Echinaforce is an ethanolic extract from Echinacea purpurea fresh plant and root. The product is registered in Switzerland for children from age 4 years on for Treatment and prevention of respiratory tract infections. | Drug: Echinaforce junior<br>* Echinacea Purpurea Extract Pill, sweetened and with orange flavour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Peak concentration of tetraen | 270 minutes measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) | Area of tetraen in plasma versus time curve | 270 minutes measurement | 
| Timepoint when Cmax is reached (tmax) | timepoint when maximum tetraen concentration is reached | 270 minutes measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echinacea, bioavailability, children