<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/NCT02198391</url>
  </required_header>
  <id_info>
    <org_study_id>920158</org_study_id>
    <nct_id>NCT02198391</nct_id>
  </id_info>
  <brief_title>Study of Echinaforce Junior Tablets in Children With Acute Colds</brief_title>
  <official_title>Multicenter Open-label, Randomized Clinical Trial to Assess the Safety and Efficacy of Echinaforce® Junior Tablets in Two Dosages for the Therapy of Common Cold Symptoms in Children (4-12 Years)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>A. Vogel AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>A. Vogel AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two&#xD;
      dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2014</start_date>
  <completion_date type="Actual">August 7, 2015</completion_date>
  <primary_completion_date type="Actual">August 7, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>tolerability assessment by physicians</measure>
    <time_frame>4 months</time_frame>
    <description>Within the observation period of 4 months a maximum of 3 colds can be treated with Echinaforce Junior tablets at the indicated dosage. At the exclusion visit the physicians rate the tolerability of Echinaforce Junior tablets as &quot;very good&quot;, &quot;good&quot;, &quot;moderate&quot; or &quot;bad&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tolerability assessment by parents/child</measure>
    <time_frame>4 months</time_frame>
    <description>The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tolerability assessment by parents/child</measure>
    <time_frame>10 days</time_frame>
    <description>The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy by parents/child</measure>
    <time_frame>4 months</time_frame>
    <description>The acute efficacy of Echinaforce Junior is rated by the parents after every acute treatment period of 10 days as well as after the observation period of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Cold Symptoms during Acute Treatment</measure>
    <time_frame>10 days</time_frame>
    <description>During acute colds parents complete a symptom diary and assess cold-related symptoms (runny and congested nose, sneezing, headache, joint pain, sore-throat, fever, cough, shivering, sleep quality, additional care) in the child</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Respiratory Tract Diseases</condition>
  <arm_group>
    <arm_group_label>3 x 1 tablet per day</arm_group_label>
    <description>Echinaforce Junior tablets (low dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 x 1 tablet per day</arm_group_label>
    <description>Echinaforce Junior tablets (high dose)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        children aged 4 - 12 years recruited in pediatrics practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 4 and 12 years&#xD;
&#xD;
          -  signed informed consent by parents and optionally be the child&#xD;
&#xD;
          -  daily access to computer / internet&#xD;
&#xD;
          -  competence of german language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  13 years or older, younger than 4 years.&#xD;
&#xD;
          -  presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at&#xD;
             inclusion&#xD;
&#xD;
          -  participation in a clinical study in the past 30 days&#xD;
&#xD;
          -  intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing&#xD;
             medicines or bronchovaxom at first treatment period&#xD;
&#xD;
          -  surgical intervention in the 3 months before inclusion or planned intervention during&#xD;
             the observation period&#xD;
&#xD;
          -  Known diabetes mellitus&#xD;
&#xD;
          -  Known and treated allergic rhinitis, atopy or asthma&#xD;
&#xD;
          -  cystic fibrosis, bronchopulmonic dysplasia, COPD&#xD;
&#xD;
          -  immune system disorders, degenerative diseases (e.g. autoimmune disease like AIDS or&#xD;
             leukosis)&#xD;
&#xD;
          -  metabolic or resorptive disorders&#xD;
&#xD;
          -  liver or kidney diseases&#xD;
&#xD;
          -  serious health problems&#xD;
&#xD;
          -  predisposition for complicated cold episodes in the judgement of the physician&#xD;
             (sinusitis, otitis media, bronchitis, pneumonia)&#xD;
&#xD;
          -  known allergy to plants of the compositae family (camomile or dandelion) or any of the&#xD;
             substances of the investigational product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnold Baechler, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. med. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin</name>
      <address>
        <city>St. Gallen</city>
        <state>Saint Gallen</state>
        <zip>9000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02198391
org study id: 920158
nct id: NCT02198391
lead sponsor: 
has dmc: No
This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two
      dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.
observational model: Cohort
time perspective: Prospective
measure: tolerability assessment by physicians
time frame: 4 months
description: Within the observation period of 4 months a maximum of 3 colds can be treated with Echinaforce Junior tablets at the indicated dosage. At the exclusion visit the physicians rate the tolerability of Echinaforce Junior tablets as "very good", "good", "moderate" or "bad"
measure: tolerability assessment by parents/child
time frame: 4 months
description: The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months
measure: tolerability assessment by parents/child
time frame: 10 days
description: The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months
measure: Assessment of efficacy by parents/child
time frame: 4 months
description: The acute efficacy of Echinaforce Junior is rated by the parents after every acute treatment period of 10 days as well as after the observation period of 4 months
measure: Assessment of Cold Symptoms during Acute Treatment
time frame: 10 days
description: During acute colds parents complete a symptom diary and assess cold-related symptoms (runny and congested nose, sneezing, headache, joint pain, sore-throat, fever, cough, shivering, sleep quality, additional care) in the child
arm group label: 3 x 1 tablet per day
description: Echinaforce Junior tablets (low dose)
arm group label: 5 x 1 tablet per day
description: Echinaforce Junior tablets (high dose)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arnold Baechler, Dr. med.
role: Principal Investigator
affiliation: Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases