Respiratory Tract DiseasesNCT02198391
Study of Echinaforce Junior Tablets in Children With Acute Colds
An observational study of Respiratory Tract Diseases, run by A. Vogel AG at 1 site in Switzerland.
Trial summary
This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds. 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 Diseases
- Type of treatment
- Pill or oral medicine
- How many people
- 79 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Oct 2014to 7 Aug 2015
- Phase
- Observational
- 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
Study population: children aged 4 - 12 years recruited in pediatrics practice
Who may be able to join
- age between 4 and 12 years
- signed informed consent by parents and optionally be the child
- daily access to computer / internet
- competence of german language
Who cannot join
- 13 years or older, younger than 4 years.
- presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at inclusion
- participation in a clinical study in the past 30 days
- intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing medicines or bronchovaxom at first treatment period
- surgical intervention in the 3 months before inclusion or planned intervention during the observation period
- Known diabetes mellitus
Show all 14Show fewer
- Known and treated allergic rhinitis, atopy or asthma
- cystic fibrosis, bronchopulmonic dysplasia, COPD
- immune system disorders, degenerative diseases (e.g. autoimmune disease like AIDS or leukosis)
- metabolic or resorptive disorders
- liver or kidney diseases
- serious health problems
- predisposition for complicated cold episodes in the judgement of the physician (sinusitis, otitis media, bronchitis, pneumonia)
- known allergy to plants of the compositae family (camomile or dandelion) or any of the substances of the investigational product
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dr. med. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin
Sankt Gallen, Canton of St. Gallen, 9000
About this study
Official title: Multicenter Open-label, Randomized Clinical Trial to Assess the Safety and Efficacy of Echinaforce® Junior Tablets in Two Dosages for the Therapy of Common Cold Symptoms in Children (4-12 Years)
This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.
- Conditions
- Respiratory Tract Diseases
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3 x 1 tablet per day | Echinaforce Junior tablets (low dose) | |
| 5 x 1 tablet per day | Echinaforce Junior tablets (high dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerability assessment by physicians
Within the observation period of 4 months a maximum of 3 colds can be treated with Echinaforce Junior tablets at the indicated dosage. At the exclusion visit the physicians rate the tolerability of Echinaforce Junior tablets as "very good", "good", "moderate" or "bad"
Measured: 4 months
Secondary outcomes (4)
tolerability assessment by parents/child
The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months
Measured: 4 months
tolerability assessment by parents/child
The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months
Measured: 10 days
Assessment of efficacy by parents/child
The acute efficacy of Echinaforce Junior is rated by the parents after every acute treatment period of 10 days as well as after the observation period of 4 months
Measured: 4 months
Assessment of Cold Symptoms during Acute Treatment
During acute colds parents complete a symptom diary and assess cold-related symptoms (runny and congested nose, sneezing, headache, joint pain, sore-throat, fever, cough, shivering, sleep quality, additional care) in the child
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study start15 Oct 2014
- Primary completion7 Aug 2015
- Study completion7 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnold Baechler, Dr. med., Principal investigator, Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198391
- Sponsor's protocol ID
- 920158
- Status last verified
- May 2021
- First submitted
- 22 Jul 2014
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
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
- Multicenter Open-label, Randomized Clinical Trial to Assess the Safety and Efficacy of Echinaforce® Junior Tablets in Two Dosages for the Therapy of Common Cold Symptoms in Children (4-12 Years)
- ClinicalTrials.gov ID
- NCT02198391
- Acronym / sponsor ID
- 920158
- Conditions
- Respiratory Tract Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 7 Aug 2015 (actual)
- Study completion
- 7 Aug 2015 (actual)
- First posted
- 23 Jul 2014 (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.
This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 x 1 tablet per day | – | –Echinaforce Junior tablets (low dose) |
| 5 x 1 tablet per day | – | –Echinaforce Junior tablets (high dose) |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children aged 4 - 12 years recruited in pediatrics practice
Key inclusion criteria (4 listed)
- age between 4 and 12 years
- signed informed consent by parents and optionally be the child
- daily access to computer / internet
- competence of german language
Key exclusion criteria (14 listed)
- 13 years or older, younger than 4 years.
- presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at inclusion
- participation in a clinical study in the past 30 days
- intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing medicines or bronchovaxom at first treatment period
- surgical intervention in the 3 months before inclusion or planned intervention during the observation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tolerability assessment by physicians
Time frame: 4 months
Within the observation period of 4 months a maximum of 3 colds can be treated with Echinaforce Junior tablets at the indicated dosage. At the exclusion visit the physicians rate the tolerability of Echinaforce Junior tablets as "very good", "good", "moderate" or "bad"
4 secondary outcomes
tolerability assessment by parents/child
Time frame: 4 months
tolerability assessment by parents/child
Time frame: 10 days
Assessment of efficacy by parents/child
Time frame: 4 months
Assessment of Cold Symptoms during Acute Treatment
Time frame: 10 days
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.
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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.
Arnold Baechler, Dr. med. principal investigator
Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Diseases, 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 14 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.
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?
tolerability assessment by physicians (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.