Overview

Echinaforce Junior Bioavailability Trial

Status:
Withdrawn
Trial end date:
2018-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
A. Vogel AG
Bioforce AG
Collaborator:
University Children's Hospital, Zurich
Criteria
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