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

September 10, 2012 updated by: DSC Services, s.r.o.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Joalis Bambi Bronchi & Joalis Bambi Analerg
10 days, 2 times per day 2,5/5 ml
Dietary supplement: Joalis Bambi Analerg
Dietary supplement: Joalis Bambi Bronchi
Placebo Comparator: Placebo & Placebo
10 days, 2 times per day 2,5/5 ml
Dietary supplement: Placebo
Sugar pill manufactured to mimic Joalis Bambi Analerg
Dietary supplement: Placebo
Sugar pill manufactured to mimic Joalis Bambi Bronchi

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Improving of quality of life observed in the visual analogue scale (VAS).
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Asthma bronchiale, age 9-18 year
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DSC Services, s.r.o.

Investigators

  • Study Director: Karel Chroust, RNDr., Ing., PhD., DSC Services, s.r.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KS-2011-05-JOALIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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