Common Cold
Conditions
Keywords
Echinacea, bioavailability, children
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.
Interventions
DRUGEchinaforce junior
Echinacea Purpurea Extract Pill, sweetened and with orange flavour
Sponsors
University Children's Hospital, Zurich
A. Vogel AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 270 minutes measurement | Peak concentration of tetraen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed