Back to resultsEchinacea Junior vs Vitamin C in Children 4-12 Years Old
Primary Purpose
Respiratory Tract Infection Viral
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Echinaforce
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Tract Infection Viral
Eligibility 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
Sites / Locations
- Dr. med. Mercedes Ogal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Echinaforce Junior Tablets
Vitamin C Tablets
Arm Description
Hydroalcoholic extract of Echinacea purpurea herb and radix
synthetically produced ascorbic acid
Outcomes
Primary Outcome Measures
cumulative number of cold days
total number of days with cold symptoms as per diary entries
Secondary Outcome Measures
Occurrence of adverse events
Occurrence of adverse events will be analysed by descriptive methods
Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)
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
Incidence of respiratory tract infections (viral RTIs)
Occurrence of colds and flu episodes
Acceptance in the view of the parents
Parents will judge the acceptance after 4 months (would you use the medicament again?)
Occurrence of adverse drug reactions
Occurrence of adverse drug reactions will be analysed by descriptive methods
Tolerability in view of the physician
physicians will judge tolerability as "bad", "moderate", "good" or "very good"
Tolerability in view of the parents
parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"
Efficacy in the view of the parents/children
Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".
accompanying virus analytics
nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses
effects on the endogenous defense
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")
Concomitant treatment and therapies
Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02971384
Brief Title
Echinacea Junior vs Vitamin C in Children 4-12 Years Old
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 25, 2016 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
July 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A. Vogel AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infection Viral
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Echinaforce Junior Tablets
Arm Type
Experimental
Arm Description
Hydroalcoholic extract of Echinacea purpurea herb and radix
Arm Title
Vitamin C Tablets
Arm Type
Active Comparator
Arm Description
synthetically produced ascorbic acid
Intervention Type
Drug
Intervention Name(s)
Echinaforce
Other Intervention Name(s)
Echinacea purpurea
Primary Outcome Measure Information:
Title
cumulative number of cold days
Description
total number of days with cold symptoms as per diary entries
Time Frame
4 months prevention
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Description
Occurrence of adverse events will be analysed by descriptive methods
Time Frame
4 months prevention
Title
Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)
Description
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
Time Frame
4 months prevention
Title
Incidence of respiratory tract infections (viral RTIs)
Description
Occurrence of colds and flu episodes
Time Frame
4 months prevention
Title
Acceptance in the view of the parents
Description
Parents will judge the acceptance after 4 months (would you use the medicament again?)
Time Frame
4 months prevention
Title
Occurrence of adverse drug reactions
Description
Occurrence of adverse drug reactions will be analysed by descriptive methods
Time Frame
4 months prevention
Title
Tolerability in view of the physician
Description
physicians will judge tolerability as "bad", "moderate", "good" or "very good"
Time Frame
4 months prevention
Title
Tolerability in view of the parents
Description
parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"
Time Frame
After 4 months prevention
Title
Efficacy in the view of the parents/children
Description
Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".
Time Frame
4 months prevention
Title
accompanying virus analytics
Description
nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses
Time Frame
4 months prevention
Title
effects on the endogenous defense
Description
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")
Time Frame
4 months prevention
Title
Concomitant treatment and therapies
Description
Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups
Time Frame
4 months prevention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercedes Ogal, Dr. med.
Organizational Affiliation
Arztpraxis für Kinder und Jugendliche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. med. Mercedes Ogal
City
Brunnen
ZIP/Postal Code
6440
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33832544
Citation
Ogal M, Johnston SL, Klein P, Schoop R. Echinacea reduces antibiotic usage in children through respiratory tract infection prevention: a randomized, blinded, controlled clinical trial. Eur J Med Res. 2021 Apr 8;26(1):33. doi: 10.1186/s40001-021-00499-6.
Results Reference
derived
Learn more about this trial
Echinacea Junior vs Vitamin C in Children 4-12 Years Old
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