Echinaforce Junior Bioavailability Trial

A. Vogel AG

Status and phase: Withdrawn; Phase 4

Conditions: Common Cold

Treatments: Drug: Echinaforce junior

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03070314

5000121

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Echinaforce junior

Experimental group

Description:

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.

Treatment:

Drug: Echinaforce junior