Echinaforce Junior Bioavailability Trial

NCT03070314 — Phase 4, Withdrawn, A. Vogel AG

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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

Registry	NCT03070314
Status	Withdrawn - no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, basic science
Sponsor	A. Vogel AG (Industry); collaborators: University Children's Hospital, Zurich
Conditions	Common Cold
Interventions	Echinaforce junior (Drug)
Dates	start 2017-02-20, primary completion 2018-06-30, completion 2018-06-30, first posted 2017-03-03, last updated 2018-07-18
Locations	1 site in Switzerland

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Echinaforce junior	Experimental	Drug: 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.

Echinaforce junior (Drug): Echinacea Purpurea Extract Pill, sweetened and with orange flavour

+Outcome measures

Primary outcomes

Peak Plasma Concentration (Cmax) [270 minutes measurement]: Peak concentration of tetraen

Secondary outcomes

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

+Eligibility

Sex: All, ages: 4 Years to 12 Years

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

+Locations (1)

Facility	City	Country	Status
University Children's Hospital (UZH-UCH), Infectiology, University of Zurich	Zurich	Switzerland