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Trial record 19 of 27 for:    Echinacea

Echinaforce Junior Bioavailability Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03070314
Recruitment Status : Withdrawn (no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.)
First Posted : March 3, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
University Children's Hospital, Zurich
Information provided by (Responsible Party):
Bioforce AG

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.

Condition or disease Intervention/treatment Phase
Common Cold Drug: Echinaforce junior Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold
Drug Information available for: Echinacea

Arm Intervention/treatment
Experimental: Echinaforce junior
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
Echinacea Purpurea Extract Pill, sweetened and with orange flavour




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 270 minutes measurement ]
    Peak concentration of tetraen


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 270 minutes measurement ]
    Area of tetraen in plasma versus time curve

  2. Timepoint when Cmax is reached (tmax) [ Time Frame: 270 minutes measurement ]
    timepoint when maximum tetraen concentration is reached



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070314


Locations
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Switzerland
University Children's Hospital (UZH-UCH), Infectiology, University of Zurich
Zurich, Switzerland, 8032
Sponsors and Collaborators
Bioforce AG
University Children's Hospital, Zurich

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Responsible Party: Bioforce AG
ClinicalTrials.gov Identifier: NCT03070314     History of Changes
Other Study ID Numbers: 5000121
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bioforce AG:
Echinacea
bioavailability
children

Additional relevant MeSH terms:
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Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases