Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg

Children Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01684137
• Other study ID #: KS-2011-05-JOALIS
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2012
• Last updated: September 10, 2012
• Start date: August 2012

Study information

• Verified date: September 2012
• Source: DSC Services, s.r.o.
• Contact: Karel Chroust, RNDr., Ing., PhD..
• Phone: +420 777 826 208
• Email: chroust[@]dscservices.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Children

Intervention

Dietary Supplement:
• Joalis Bambi Analerg

• Joalis Bambi Bronchi

• Placebo
Sugar pill manufactured to mimic Joalis Bambi Analerg
• Placebo
Sugar pill manufactured to mimic Joalis Bambi Bronchi

Locations

Country	Name	City	State
Czech Republic	Alergologická ambulance	Zlín

Sponsors (1)

Lead Sponsor	Collaborator
DSC Services, s.r.o.

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Asthma bronchiale, age 9-18 year		1 year	No
Primary	Reduction of the total IgE (IU/ml) antibody.		1 year	No
Primary	Improving of vital capacity measured by spirometry (litre).		1 year	No
Primary	Improving of lung volume measured by spirometry (litre).		1 year	No
Secondary	Improving of quality of life observed in the visual analogue scale (VAS).		1 year	No