Respiratory Tract Infection ViralPhase 3NCT02971384
Echinacea Junior vs Vitamin C in Children 4-12 Years Old
A Phase 3 study testing Echinaforce in people with Respiratory Tract Infection Viral, run by A. Vogel AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infection Viral
- What is being tested?
- Echinaforce
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Nov 2016to 3 Jul 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-12 years
- written informed consent by parents and optionally by child
- daily Access to computer/email
- german language skills
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Respiratory Tract Infection Viral
- Being tested
- Echinaforce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchinaforceDrug
Also called Echinacea purpurea
| Study group | Role | What they receive |
|---|---|---|
| Echinaforce Junior Tablets | Experimental | Hydroalcoholic extract of Echinacea purpurea herb and radix Receives: Drug: Echinaforce |
| Vitamin C Tablets | Active comparator | synthetically produced ascorbic acid Receives: Drug: Echinaforce |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative number of cold days
total number of days with cold symptoms as per diary entries
Measured: 4 months prevention
Secondary outcomes (11)
Occurrence of adverse events
Occurrence of adverse events will be analysed by descriptive methods
Measured: 4 months prevention
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
Measured: 4 months prevention
Incidence of respiratory tract infections (viral RTIs)
Occurrence of colds and flu episodes
Measured: 4 months prevention
Acceptance in the view of the parents
Parents will judge the acceptance after 4 months (would you use the medicament again?)
Measured: 4 months prevention
Occurrence of adverse drug reactions
Occurrence of adverse drug reactions will be analysed by descriptive methods
Measured: 4 months prevention
Tolerability in view of the physician
physicians will judge tolerability as "bad", "moderate", "good" or "very good"
Measured: 4 months prevention
Tolerability in view of the parents
parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"
Measured: After 4 months prevention
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".
Measured: 4 months prevention
accompanying virus analytics
nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses
Measured: 4 months prevention
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")
Measured: 4 months prevention
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
Measured: 4 months prevention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start25 Nov 2016
- Primary completion3 Aug 2017
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract Infection ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mercedes Ogal, Dr. med., Principal investigator, Arztpraxis für Kinder und Jugendliche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971384
- Sponsor's protocol ID
- 5000120
- Status last verified
- Dec 2017
- First submitted
- 16 Nov 2016
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33832544
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02971384
- Acronym / sponsor ID
- 5000120
- Conditions
- Respiratory Tract Infection Viral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echinaforce Junior Tablets | Experimental | Drug: EchinaforceHydroalcoholic extract of Echinacea purpurea herb and radix |
| Vitamin C Tablets | Active comparator | Drug: Echinaforcesynthetically produced ascorbic acid |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 4-12 years
- written informed consent by parents and optionally by child
- daily Access to computer/email
- german language skills
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchinaforceAlso: Echinacea purpurea | Drug | Echinaforce Junior Tablets, Vitamin C Tablets |
Primary outcome
cumulative number of cold days
Time frame: 4 months prevention
total number of days with cold symptoms as per diary entries
11 secondary outcomes
Occurrence of adverse events
Time frame: 4 months prevention
Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)
Time frame: 4 months prevention
Incidence of respiratory tract infections (viral RTIs)
Time frame: 4 months prevention
Acceptance in the view of the parents
Time frame: 4 months prevention
Occurrence of adverse drug reactions
Time frame: 4 months prevention
Tolerability in view of the physician
Time frame: 4 months prevention
Tolerability in view of the parents
Time frame: After 4 months prevention
Efficacy in the view of the parents/children
Time frame: 4 months prevention
accompanying virus analytics
Time frame: 4 months prevention
effects on the endogenous defense
Time frame: 4 months prevention
Concomitant treatment and therapies
Time frame: 4 months prevention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Derived from this study: PubMed 33832544Ogal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercedes Ogal, Dr. med. principal investigator
Arztpraxis für Kinder und Jugendliche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Echinaforce in people with Respiratory Tract Infection Viral, run by A. Vogel AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative number of cold days (time frame: 4 months prevention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.