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Echinaforce Junior Bioavailability Trial

Primary Purpose

Common Cold

Status
Withdrawn
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Echinaforce junior
Sponsored by
A. Vogel AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Common Cold focused on measuring Echinacea, bioavailability, children

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echinaforce junior

Arm 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.

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)
Peak concentration of tetraen

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC)
Area of tetraen in plasma versus time curve
Timepoint when Cmax is reached (tmax)
timepoint when maximum tetraen concentration is reached

Full Information

First Posted
February 22, 2017
Last Updated
July 17, 2018
Sponsor
A. Vogel AG
Collaborators
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03070314
Brief Title
Echinaforce Junior Bioavailability 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A. Vogel AG
Collaborators
University Children's Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Echinacea, bioavailability, children

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echinaforce junior
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Echinaforce junior
Intervention Description
Echinacea Purpurea Extract Pill, sweetened and with orange flavour
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Peak concentration of tetraen
Time Frame
270 minutes measurement
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Description
Area of tetraen in plasma versus time curve
Time Frame
270 minutes measurement
Title
Timepoint when Cmax is reached (tmax)
Description
timepoint when maximum tetraen concentration is reached
Time Frame
270 minutes measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Children's Hospital (UZH-UCH), Infectiology, University of Zurich
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Echinaforce Junior Bioavailability Trial

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