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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Recruitment Status : Withdrawn (no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.)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

Tracking Information
First Submitted Date  ICMJE February 22, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE February 20, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
Peak Plasma Concentration (Cmax) [ Time Frame: 270 minutes measurement ]
Peak concentration of tetraen
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 270 minutes measurement ]
    Area of tetraen in plasma versus time curve
  • Timepoint when Cmax is reached (tmax) [ Time Frame: 270 minutes measurement ]
    timepoint when maximum tetraen concentration is reached
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Echinaforce Junior Bioavailability Trial
Official Title  ICMJE Bioavailability of an Echinacea Product (Echinaforce® Junior) in Children With a Common Cold, Aged 4-12 Years After Intake of a Daily Dosage
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Common Cold
Intervention  ICMJE Drug: Echinaforce junior
Echinacea Purpurea Extract Pill, sweetened and with orange flavour
Study Arms  ICMJE 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.
Intervention: Drug: Echinaforce junior
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 17, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
18
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070314
Other Study ID Numbers  ICMJE 5000121
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bioforce AG
Study Sponsor  ICMJE Bioforce AG
Collaborators  ICMJE University Children's Hospital, Zurich
Investigators  ICMJE Not Provided
PRS Account Bioforce AG
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP