Echinaforce Junior Bioavailability Trial

NCT ID: NCT03070314

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2018-06-30

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.

Conditions

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Common Cold

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Echinaforce junior

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.

Group Type EXPERIMENTAL

Echinaforce junior

Intervention Type DRUG

Echinacea Purpurea Extract Pill, sweetened and with orange flavour

Interventions

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Echinaforce junior

Echinacea Purpurea Extract Pill, sweetened and with orange flavour

Intervention Type DRUG

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role collaborator

A. Vogel AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Children's Hospital (UZH-UCH), Infectiology, University of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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5000121

Identifier Type: -

Identifier Source: org_study_id

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