Echinaforce Junior Bioavailability Trial

Phase 4

Withdrawn

• Conditions: Common Cold
• Interventions: Drug: Echinaforce junior

• Registration Number: NCT03070314
• Lead Sponsor: A. Vogel AG

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echinaforce junior	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.

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	270 minutes measurement	Peak concentration of tetraen

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	270 minutes measurement	Area of tetraen in plasma versus time curve
Timepoint when Cmax is reached (tmax)	270 minutes measurement	timepoint when maximum tetraen concentration is reached

Trial Locations

Locations (1)

University Children's Hospital (UZH-UCH), Infectiology, University of Zurich; 🇨🇭 Zurich, Switzerland