We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Echinacea Junior vs Vitamin C in Children 4-12 Years Old

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: NCT02971384
Recruitment Status : Completed
First Posted : November 23, 2016
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
A. Vogel AG

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg) in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract infections.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infection Viral Drug: Echinaforce Phase 3

Detailed Description:

200 children aged 4-12 years are recruited by pediatricians and general practitioners and are allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C. Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment break and an intermediate study visit (V2). Thereafter children continue with preventive Treatment for another 2 months, followed by exclusion visit (V3).

Parents are required to contact a study coordinator at the occurrence of acute respiratory Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode parents will sample nasal secretion, which will be analysed for common respiratory agents.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Controlled, Randomized, Double-blind, Multicentre Study on Efficacy and Safety of Echinaforce Junior Tablets in Comparison With Vitamin C for the Prevention of Viral Respiratory Tract Infections in Children (4-12 Years)
Actual Study Start Date : November 25, 2016
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : July 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Echinaforce Junior Tablets
Hydroalcoholic extract of Echinacea purpurea herb and radix
 Drug: Echinaforce
Other Name: Echinacea purpurea
Active Comparator: Vitamin C Tablets
synthetically produced ascorbic acid
 Drug: Echinaforce
Other Name: Echinacea purpurea


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. cumulative number of cold days [ Time Frame: 4 months prevention ]
    total number of days with cold symptoms as per diary entries


Secondary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: 4 months prevention ]
    Occurrence of adverse events will be analysed by descriptive methods

  2. Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score) [ Time Frame: 4 months prevention ]
    Patients will rate respiratory symptoms in a diary at occurrence of acute respiratory tract infections and the entries will be analysed descriptively for the two treatment groups

  3. Incidence of respiratory tract infections (viral RTIs) [ Time Frame: 4 months prevention ]
    Occurrence of colds and flu episodes

  4. Acceptance in the view of the parents [ Time Frame: 4 months prevention ]
    Parents will judge the acceptance after 4 months (would you use the medicament again?)

  5. Occurrence of adverse drug reactions [ Time Frame: 4 months prevention ]
    Occurrence of adverse drug reactions will be analysed by descriptive methods

  6. Tolerability in view of the physician [ Time Frame: 4 months prevention ]
    physicians will judge tolerability as "bad", "moderate", "good" or "very good"

  7. Tolerability in view of the parents [ Time Frame: After 4 months prevention ]
    parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"

  8. Efficacy in the view of the parents/children [ Time Frame: 4 months prevention ]
    Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".

  9. accompanying virus analytics [ Time Frame: 4 months prevention ]
    nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses

  10. effects on the endogenous defense [ Time Frame: 4 months prevention ]
    Question will be asked " do you think that the prevention had the follwing effects on the endogenous defense in your child?" (unchanged; improved; significantly improved")

  11. Concomitant treatment and therapies [ Time Frame: 4 months prevention ]
    Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 4-12 years
  • written informed consent by parents and optionally by child
  • daily Access to computer/email
  • german language skills

Exclusion Criteria:

  • 13 years or older, younger than 4 years
  • participation in a clinical study during past 30 days
  • intake of antimicrobial, antiviral, immunosuppressive substances, salicylic medicaments (like Aspirin)
  • surgical intervention 3 months Prior to inclusion or planned intervention during the observation period
  • known Diabetes mellitus
  • known and treated atopy or Asthma
  • cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD)
  • diseases of the immunosystem (like autoimmune disorders, degenerative illnesses (like AIDS or leucosis))
  • Metabolic or Resorption disorders
  • Liver or kidney diseases
  • Serious health Problems (e.g. neurological Problems)
  • known allergies against compositae (e.g. camomile or dandelion) or any of the substances of the investigational product
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02971384


Locations
Layout table for location information
Switzerland
Dr. med. Mercedes Ogal
Brunnen, Switzerland, 6440
Sponsors and Collaborators
A. Vogel AG
Investigators
Layout table for investigator information
Principal Investigator: Mercedes Ogal, Dr. med. Arztpraxis für Kinder und Jugendliche
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: A. Vogel AG
ClinicalTrials.gov Identifier: NCT02971384    
Other Study ID Numbers: 5000120
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Respiratory Tract Infections
Virus Diseases
Respiratory Tract Diseases