ChildrenNCT01684137
Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg
A study testing Joalis Bambi Analerg and Joalis Bambi Bronchi in people with Children, run by DSC Services, s.r.o. at 1 site in Czechia.
Trial summary
Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry. Improving quality of life observed in the visual analogue scale (VAS). Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Children
- What is being tested?
- Joalis Bambi Analerg and Joalis Bambi Bronchi
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment
- 9-18 years
- signed Infromed Conset
Who cannot join
- subjects who have previously used a food suplemts Joalis
- subjects with known intolerance or hypersensitivity to the components of food supplements
- subjects with alcohol abuse or drugs at the time of recruitment into the study
- subjects enrolled in another clinical trial in the last 1 month before enrollment in this study
- subjects in a situation which in the opinion of a doctor may interfere with optimal participation in the study or can pose a risk to the subjects
- pregnant girls, lactating girls and girls of childbearing age without adequate contraception
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Alergologická ambulance
Zlín, 760 01
Albert Drštička, MUDr., +420 577 225 992, drstickalabert@seznam.cz
About this study
Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry.
Improving quality of life observed in the visual analogue scale (VAS).
- Conditions
- Children
- Being tested
- Joalis Bambi Analerg, Joalis Bambi Bronchi, Placebo
- Keywords
- Food supplements, Asthma bronchiale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joalis Bambi AnalergDietary supplement
Joalis Bambi BronchiDietary supplement
PlaceboDietary supplement
Sugar pill manufactured to mimic Joalis Bambi Analerg
PlaceboDietary supplement
Sugar pill manufactured to mimic Joalis Bambi Bronchi
| Study group | Role | What they receive |
|---|---|---|
| Joalis Bambi Bronchi & Joalis Bambi Analerg | Active comparator | 10 days, 2 times per day 2,5/5 ml Receives: Dietary Supplement: Joalis Bambi Analerg; Dietary Supplement: Joalis Bambi Bronchi |
| Placebo & Placebo | Placebo comparator | 10 days, 2 times per day 2,5/5 ml Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the total IgE (IU/ml) antibody.
Measured: 1 year
Improving of vital capacity measured by spirometry (litre).
Measured: 1 year
Improving of lung volume measured by spirometry (litre).
Measured: 1 year
Secondary outcomes (1)
Improving of quality of life observed in the visual analogue scale (VAS).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DSC Services, s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karel Chroust, RNDr., Ing., PhD., Study director, DSC Services, s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684137
- Sponsor's protocol ID
- KS-2011-05-JOALIS
- Status last verified
- Sep 2012
- First submitted
- 21 Aug 2012
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg
- ClinicalTrials.gov ID
- NCT01684137
- Acronym / sponsor ID
- KS-2011-05-JOALIS
- Conditions
- Children
- Keywords
- Food supplements, Asthma bronchiale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DSC Services, s.r.o.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 12 Sep 2012 (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.
Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry.
Improving quality of life observed in the visual analogue scale (VAS).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joalis Bambi Bronchi & Joalis Bambi Analerg | Active comparator | Dietary Supplement: Joalis Bambi Analerg, Dietary Supplement: Joalis Bambi Bronchi10 days, 2 times per day 2,5/5 ml |
| Placebo & Placebo | Placebo comparator | Dietary Supplement: Placebo10 days, 2 times per day 2,5/5 ml |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment
- 9-18 years
- signed Infromed Conset
Key exclusion criteria (6 listed)
- subjects who have previously used a food suplemts Joalis
- subjects with known intolerance or hypersensitivity to the components of food supplements
- subjects with alcohol abuse or drugs at the time of recruitment into the study
- subjects enrolled in another clinical trial in the last 1 month before enrollment in this study
- subjects in a situation which in the opinion of a doctor may interfere with optimal participation in the study or can pose a risk to the subjects
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 |
|---|---|---|
| Joalis Bambi Analerg | Dietary supplement | Joalis Bambi Bronchi & Joalis Bambi Analerg |
| Joalis Bambi Bronchi | Dietary supplement | Joalis Bambi Bronchi & Joalis Bambi Analerg |
| PlaceboSugar pill manufactured to mimic Joalis Bambi Analerg | Dietary supplement | Placebo & Placebo |
| PlaceboSugar pill manufactured to mimic Joalis Bambi Bronchi | Dietary supplement | Placebo & Placebo |
Primary outcome
Reduction of the total IgE (IU/ml) antibody.
Time frame: 1 year
Improving of vital capacity measured by spirometry (litre).
Time frame: 1 year
Improving of lung volume measured by spirometry (litre).
Time frame: 1 year
1 secondary outcome
Improving of quality of life observed in the visual analogue scale (VAS).
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
Related trials for Children
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
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.
Karel Chroust, RNDr., Ing., PhD. study director
DSC Services, s.r.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joalis Bambi Analerg and Joalis Bambi Bronchi in people with Children, run by DSC Services, s.r.o. at 1 site in Czechia.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Sep 2012. 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 Czechia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karel Chroust, RNDr., Ing., PhD.. (+420 777 826 208, chroust@dscservices.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the total IgE (IU/ml) antibody. (time frame: 1 year). The study lists 3 primary outcomes in all. 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 12 Sep 2012.