We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by DSC Services, s.r.o..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684137
First Posted: September 12, 2012
Last Update Posted: September 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DSC Services, s.r.o.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)

Resource links provided by NLM:


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 ]
  • Improving of vital capacity measured by spirometry (litre). [ Time Frame: 1 year ]
  • Improving of lung volume measured by spirometry (litre). [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Improving of quality of life observed in the visual analogue scale (VAS). [ Time Frame: 1 year ]

Other Outcome Measures:
  • Asthma bronchiale, age 9-18 year [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: DSC Services, s.r.o.
ClinicalTrials.gov Identifier: NCT01684137     History of Changes
Other Study ID Numbers: KS-2011-05-JOALIS
First Submitted: August 21, 2012
First Posted: September 12, 2012
Last Update Posted: September 12, 2012
Last Verified: September 2012

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