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

NCT ID: NCT01684137

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Brief Summary

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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

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Conditions

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Children

Keywords

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Food supplements Asthma bronchiale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Joalis Bambi Bronchi & Joalis Bambi Analerg

10 days, 2 times per day 2,5/5 ml

Group Type ACTIVE_COMPARATOR

Joalis Bambi Analerg

Intervention Type DIETARY_SUPPLEMENT

Joalis Bambi Bronchi

Intervention Type DIETARY_SUPPLEMENT

Placebo & Placebo

10 days, 2 times per day 2,5/5 ml

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Sugar pill manufactured to mimic Joalis Bambi Analerg

Placebo

Intervention Type DIETARY_SUPPLEMENT

Sugar pill manufactured to mimic Joalis Bambi Bronchi

Interventions

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Joalis Bambi Analerg

Intervention Type DIETARY_SUPPLEMENT

Joalis Bambi Bronchi

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sugar pill manufactured to mimic Joalis Bambi Analerg

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sugar pill manufactured to mimic Joalis Bambi Bronchi

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DSC Services, s.r.o.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karel Chroust, RNDr., Ing., PhD.

Role: STUDY_DIRECTOR

DSC Services, s.r.o.

Locations

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Alergologická ambulance

Zlín, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Karel Chroust, RNDr., Ing., PhD..

Role: CONTACT

Phone: +420 777 826 208

Email: [email protected]

Facility Contacts

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Albert Drštička, MUDr.

Role: primary

Other Identifiers

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KS-2011-05-JOALIS

Identifier Type: -

Identifier Source: org_study_id