NCT01684137

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

August 21, 2012

Last Update Submit

September 10, 2012

Conditions

Children

Keywords

Food supplementsAsthma bronchiale

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Improving of quality of life observed in the visual analogue scale (VAS).

    1 year

Other Outcomes (1)

  • Asthma bronchiale, age 9-18 year

    1 year

Study Arms (2)

Joalis Bambi Bronchi & Joalis Bambi Analerg

ACTIVE COMPARATOR

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

Dietary Supplement: Joalis Bambi AnalergDietary Supplement: Joalis Bambi Bronchi

Placebo & Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Joalis Bambi AnalergDIETARY_SUPPLEMENT
Joalis Bambi Bronchi & Joalis Bambi Analerg
Joalis Bambi BronchiDIETARY_SUPPLEMENT
Joalis Bambi Bronchi & Joalis Bambi Analerg
PlaceboDIETARY_SUPPLEMENT

Sugar pill manufactured to mimic Joalis Bambi Analerg

Placebo & Placebo

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment
  • years
  • signed Infromed Conset

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alergologická ambulance

Zlín, 760 01, Czechia

RECRUITING

Study Officials

  • Karel Chroust, RNDr., Ing., PhD.

    DSC Services, s.r.o.

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+420 777 826 208chroust@dscservices.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2012

First Posted

September 12, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

CZ(1)