Echinaforce Junior Bioavailability Trial

NCT03070314 | Withdrawn Phase 4 DMC

• 1 other identifier: 5000121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Keywords

Echinacea; bioavailability; children

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax)

  Peak concentration of tetraen

  270 minutes measurement

Secondary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC)

  270 minutes measurement

• Timepoint when Cmax is reached (tmax)

  270 minutes measurement

Study Arms (1)

Echinaforce junior

EXPERIMENTAL

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.

Drug: Echinaforce junior

Interventions

Echinaforce junior DRUG

Echinacea Purpurea Extract Pill, sweetened and with orange flavour

Echinaforce junior

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A. Vogel AG: lead
• University Children's Hospital, Zurich: collaborator

Study Sites (1)

University Children's Hospital (UZH-UCH), Infectiology, University of Zurich

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: February 20, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)