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

This study is currently recruiting participants.
Verified September 2012 by DSC Services, s.r.o.
Sponsor:
Information provided by (Responsible Party):
DSC Services, s.r.o.
ClinicalTrials.gov Identifier:
NCT01684137
First received: August 21, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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).


Condition Intervention
Children
 Dietary Supplement: Joalis Bambi Analerg
Dietary Supplement: Joalis Bambi Bronchi
Dietary Supplement: Placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DSC Services, s.r.o.:

Primary Outcome Measures:
  • Reduction of the total IgE (IU/ml) antibody. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improving of vital capacity measured by spirometry (litre). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improving of lung volume measured by spirometry (litre). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improving of quality of life observed in the visual analogue scale (VAS). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Asthma bronchiale, age 9-18 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684137

Contacts
Contact: Karel Chroust, RNDr., Ing., PhD.. +420 777 826 208 chroust@dscservices.cz

Locations
Czech Republic
Alergologická ambulance Recruiting
Zlín, Czech Republic, 760 01
Contact: Albert Drštička, MUDr.     +420 577 225 992     drstickalabert@seznam.cz    
Sponsors and Collaborators
DSC Services, s.r.o.
Investigators
Study Director: Karel Chroust, RNDr., Ing., PhD. DSC Services, s.r.o.
  More Information

No publications provided

Responsible Party: DSC Services, s.r.o.
ClinicalTrials.gov Identifier: NCT01684137     History of Changes
Other Study ID Numbers: KS-2011-05-JOALIS
Study First Received: August 21, 2012
Last Updated: September 10, 2012
Health Authority: Czech Republic: Ethics Committee

Keywords provided by DSC Services, s.r.o.:
Food supplements
Asthma bronchiale

ClinicalTrials.gov processed this record on May 21, 2013