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

Not Applicable

• Conditions: Children
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Joalis Bambi Analerg; Dietary Supplement: Joalis Bambi Bronchi

• Registration Number: NCT01684137
• Lead Sponsor: DSC Services, s.r.o.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-21
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-10
• Last Update Submitted: 2012-09-10
• Study First Posted: 2012-09-12
• Last Update Posted: 2012-09-12
• Primary Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo & Placebo	Placebo	10 days, 2 times per day 2,5/5 ml
Joalis Bambi Bronchi & Joalis Bambi Analerg	Joalis Bambi Analerg	10 days, 2 times per day 2,5/5 ml
Joalis Bambi Bronchi & Joalis Bambi Analerg	Joalis Bambi Bronchi	10 days, 2 times per day 2,5/5 ml

Primary Outcome Measures

Name	Time	Method
Reduction of the total IgE (IU/ml) antibody.	1 year
Improving of vital capacity measured by spirometry (litre).	1 year
Improving of lung volume measured by spirometry (litre).	1 year

Secondary Outcome Measures

Name	Time	Method
Improving of quality of life observed in the visual analogue scale (VAS).	1 year

Trial Locations

Locations (1)

Alergologická ambulance; 🇨🇿 Zlín, Czech Republic