<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01684137</url>
  </required_header>
  <id_info>
    <org_study_id>KS-2011-05-JOALIS</org_study_id>
    <nct_id>NCT01684137</nct_id>
  </id_info>
  <brief_title>Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>DSC Services, s.r.o.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DSC Services, s.r.o.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reduction of the total IgE antibody, improved vital capacity and lung volume measured by&#xD;
      spirometry.&#xD;
&#xD;
      Improving quality of life observed in the visual analogue scale (VAS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of the total IgE (IU/ml) antibody.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Improving of vital capacity measured by spirometry (litre).</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Improving of lung volume measured by spirometry (litre).</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improving of quality of life observed in the visual analogue scale (VAS).</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Asthma bronchiale, age 9-18 year</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Joalis Bambi Bronchi &amp; Joalis Bambi Analerg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 days, 2 times per day 2,5/5 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>10 days, 2 times per day 2,5/5 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Joalis Bambi Analerg</intervention_name>
    <arm_group_label>Joalis Bambi Bronchi &amp; Joalis Bambi Analerg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Joalis Bambi Bronchi</intervention_name>
    <arm_group_label>Joalis Bambi Bronchi &amp; Joalis Bambi Analerg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sugar pill manufactured to mimic Joalis Bambi Analerg</description>
    <arm_group_label>Placebo &amp; Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sugar pill manufactured to mimic Joalis Bambi Bronchi</description>
    <arm_group_label>Placebo &amp; Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with&#xD;
             other allergic symptoms treating with classic pharmacological treatment&#xD;
&#xD;
          -  9-18 years&#xD;
&#xD;
          -  signed Infromed Conset&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who have previously used a food suplemts Joalis&#xD;
&#xD;
          -  subjects with known intolerance or hypersensitivity to the components of food&#xD;
             supplements&#xD;
&#xD;
          -  subjects with alcohol abuse or drugs at the time of recruitment into the study&#xD;
&#xD;
          -  subjects enrolled in another clinical trial in the last 1 month before enrollment in&#xD;
             this study&#xD;
&#xD;
          -  subjects in a situation which in the opinion of a doctor may interfere with optimal&#xD;
             participation in the study or can pose a risk to the subjects&#xD;
&#xD;
          -  pregnant girls, lactating girls and girls of childbearing age without adequate&#xD;
             contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karel Chroust, RNDr., Ing., PhD.</last_name>
    <role>Study Director</role>
    <affiliation>DSC Services, s.r.o.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karel Chroust, RNDr., Ing., PhD..</last_name>
    <phone>+420 777 826 208</phone>
    <email>chroust@dscservices.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alergologická ambulance</name>
      <address>
        <city>Zlín</city>
        <zip>760 01</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Albert Drštička, MUDr.</last_name>
      <phone>+420 577 225 992</phone>
      <email>drstickalabert@seznam.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czech Republic</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food supplements</keyword>
  <keyword>Asthma bronchiale</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684137
org study id: KS-2011-05-JOALIS
nct id: NCT01684137
lead sponsor: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Reduction of the total IgE (IU/ml) antibody.
time frame: 1 year
measure: Improving of vital capacity measured by spirometry (litre).
time frame: 1 year
measure: Improving of lung volume measured by spirometry (litre).
time frame: 1 year
measure: Improving of quality of life observed in the visual analogue scale (VAS).
time frame: 1 year
measure: Asthma bronchiale, age 9-18 year
time frame: 1 year
arm group label: Joalis Bambi Bronchi & Joalis Bambi Analerg
arm group type: Active Comparator
description: 10 days, 2 times per day 2,5/5 ml
arm group label: Placebo & Placebo
arm group type: Placebo Comparator
description: 10 days, 2 times per day 2,5/5 ml
intervention type: Dietary Supplement
intervention name: Joalis Bambi Analerg
arm group label: Joalis Bambi Bronchi & Joalis Bambi Analerg
intervention type: Dietary Supplement
intervention name: Joalis Bambi Bronchi
arm group label: Joalis Bambi Bronchi & Joalis Bambi Analerg
intervention type: Dietary Supplement
intervention name: Placebo
description: Sugar pill manufactured to mimic Joalis Bambi Analerg
arm group label: Placebo & Placebo
intervention type: Dietary Supplement
intervention name: Placebo
description: Sugar pill manufactured to mimic Joalis Bambi Bronchi
arm group label: Placebo & Placebo
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
healthy volunteers: No
last name: Karel Chroust, RNDr., Ing., PhD.
role: Study Director
affiliation: DSC Services, s.r.o.
last name: Karel Chroust, RNDr., Ing., PhD..
phone: +420 777 826 208
email: chroust@dscservices.cz
facility: 
status: Recruiting
contact: 
country: Czech Republic
responsible party type: Sponsor