Echinaforce Junior Bioavailability Trial
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|ClinicalTrials.gov Identifier: NCT03070314|
Recruitment Status : Withdrawn (no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.)
First Posted : March 3, 2017
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Common Cold||Drug: Echinaforce junior||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Primary Purpose:||Basic Science|
|Official Title:||Bioavailability of an Echinacea Product (Echinaforce® Junior) in Children With a Common Cold, Aged 4-12 Years After Intake of a Daily Dosage|
|Actual Study Start Date :||February 20, 2017|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 2018|
Experimental: 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.
Drug: Echinaforce junior
Echinacea Purpurea Extract Pill, sweetened and with orange flavour
- Peak Plasma Concentration (Cmax) [ Time Frame: 270 minutes measurement ]Peak concentration of tetraen
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 270 minutes measurement ]Area of tetraen in plasma versus time curve
- Timepoint when Cmax is reached (tmax) [ Time Frame: 270 minutes measurement ]timepoint when maximum tetraen concentration is reached
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070314
|University Children's Hospital (UZH-UCH), Infectiology, University of Zurich|
|Zurich, Switzerland, 8032|