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NCT03070314 Clinical Trial

Echinaforce Junior Bioavailability Trial

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03070314
Other study ID # 5000121
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date February 20, 2017
Est. completion date June 30, 2018

Study information
Verified date July 2018
Source Bioforce AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland University Children's Hospital (UZH-UCH), Infectiology, University of Zurich Zurich

Sponsors (2)
Lead Sponsor Collaborator
Bioforce AG University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax) Peak concentration of tetraen 270 minutes measurement
Secondary Area under the plasma concentration versus time curve (AUC) Area of tetraen in plasma versus time curve 270 minutes measurement
Secondary Timepoint when Cmax is reached (tmax) timepoint when maximum tetraen concentration is reached 270 minutes measurement
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