<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/NCT02971384</url>
  </required_header>
  <id_info>
    <org_study_id>5000120</org_study_id>
    <nct_id>NCT02971384</nct_id>
  </id_info>
  <brief_title>Echinacea Junior vs Vitamin C in Children 4-12 Years Old</brief_title>
  <official_title>Controlled, Randomized, Double-blind, Multicentre Study on Efficacy and Safety of Echinaforce Junior Tablets in Comparison With Vitamin C for the Prevention of Viral Respiratory Tract Infections 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>
      Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg)&#xD;
      in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract&#xD;
      infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      200 children aged 4-12 years are recruited by pediatricians and general practitioners and are&#xD;
      allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C.&#xD;
      Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment&#xD;
      break and an intermediate study visit (V2). Thereafter children continue with preventive&#xD;
      Treatment for another 2 months, followed by exclusion visit (V3).&#xD;
&#xD;
      Parents are required to contact a study coordinator at the occurrence of acute respiratory&#xD;
      Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode&#xD;
      parents will sample nasal secretion, which will be analysed for common respiratory agents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2016</start_date>
  <completion_date type="Actual">July 3, 2018</completion_date>
  <primary_completion_date type="Actual">August 3, 2017</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cumulative number of cold days</measure>
    <time_frame>4 months prevention</time_frame>
    <description>total number of days with cold symptoms as per diary entries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Occurrence of adverse events will be analysed by descriptive methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Patients will rate respiratory symptoms in a diary at occurrence of acute respiratory tract infections and the entries will be analysed descriptively for the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of respiratory tract infections (viral RTIs)</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Occurrence of colds and flu episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance in the view of the parents</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Parents will judge the acceptance after 4 months (would you use the medicament again?)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse drug reactions</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Occurrence of adverse drug reactions will be analysed by descriptive methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability in view of the physician</measure>
    <time_frame>4 months prevention</time_frame>
    <description>physicians will judge tolerability as &quot;bad&quot;, &quot;moderate&quot;, &quot;good&quot; or &quot;very good&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability in view of the parents</measure>
    <time_frame>After 4 months prevention</time_frame>
    <description>parents will judge the tolerability after 2 and 4 months treatment as &quot;bad&quot;, &quot;moderate&quot;, &quot;good&quot; or &quot;very good&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy in the view of the parents/children</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Parents/children will give their subjective impression of efficacy by ratings &quot;bad&quot;, &quot;moderate&quot;, &quot;good&quot; or &quot; very good&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>accompanying virus analytics</measure>
    <time_frame>4 months prevention</time_frame>
    <description>nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects on the endogenous defense</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Question will be asked &quot; do you think that the prevention had the follwing effects on the endogenous defense in your child?&quot; (unchanged; improved; significantly improved&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant treatment and therapies</measure>
    <time_frame>4 months prevention</time_frame>
    <description>Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Respiratory Tract Infection Viral</condition>
  <arm_group>
    <arm_group_label>Echinaforce Junior Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydroalcoholic extract of Echinacea purpurea herb and radix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin C Tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>synthetically produced ascorbic acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Echinaforce</intervention_name>
    <arm_group_label>Echinaforce Junior Tablets</arm_group_label>
    <arm_group_label>Vitamin C Tablets</arm_group_label>
    <other_name>Echinacea purpurea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4-12 years&#xD;
&#xD;
          -  written informed consent by parents and optionally by child&#xD;
&#xD;
          -  daily Access to computer/email&#xD;
&#xD;
          -  german language skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  13 years or older, younger than 4 years&#xD;
&#xD;
          -  participation in a clinical study during past 30 days&#xD;
&#xD;
          -  intake of antimicrobial, antiviral, immunosuppressive substances, salicylic&#xD;
             medicaments (like Aspirin)&#xD;
&#xD;
          -  surgical intervention 3 months Prior to inclusion or planned intervention during the&#xD;
             observation period&#xD;
&#xD;
          -  known Diabetes mellitus&#xD;
&#xD;
          -  known and treated atopy or Asthma&#xD;
&#xD;
          -  cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease&#xD;
             (COPD)&#xD;
&#xD;
          -  diseases of the immunosystem (like autoimmune disorders, degenerative illnesses (like&#xD;
             AIDS or leucosis))&#xD;
&#xD;
          -  Metabolic or Resorption disorders&#xD;
&#xD;
          -  Liver or kidney diseases&#xD;
&#xD;
          -  Serious health Problems (e.g. neurological Problems)&#xD;
&#xD;
          -  known allergies against compositae (e.g. 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>Mercedes Ogal, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arztpraxis für Kinder und Jugendliche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. med. Mercedes Ogal</name>
      <address>
        <city>Brunnen</city>
        <zip>6440</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</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>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02971384
org study id: 5000120
nct id: NCT02971384
lead sponsor: 
has dmc: No
Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg)
      in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract
      infections.
200 children aged 4-12 years are recruited by pediatricians and general practitioners and are
      allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C.
      Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment
      break and an intermediate study visit (V2). Thereafter children continue with preventive
      Treatment for another 2 months, followed by exclusion visit (V3).

      Parents are required to contact a study coordinator at the occurrence of acute respiratory
      Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode
      parents will sample nasal secretion, which will be analysed for common respiratory agents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: cumulative number of cold days
time frame: 4 months prevention
description: total number of days with cold symptoms as per diary entries
measure: Occurrence of adverse events
time frame: 4 months prevention
description: Occurrence of adverse events will be analysed by descriptive methods
measure: Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)
time frame: 4 months prevention
description: Patients will rate respiratory symptoms in a diary at occurrence of acute respiratory tract infections and the entries will be analysed descriptively for the two treatment groups
measure: Incidence of respiratory tract infections (viral RTIs)
time frame: 4 months prevention
description: Occurrence of colds and flu episodes
measure: Acceptance in the view of the parents
time frame: 4 months prevention
description: Parents will judge the acceptance after 4 months (would you use the medicament again?)
measure: Occurrence of adverse drug reactions
time frame: 4 months prevention
description: Occurrence of adverse drug reactions will be analysed by descriptive methods
measure: Tolerability in view of the physician
time frame: 4 months prevention
description: physicians will judge tolerability as "bad", "moderate", "good" or "very good"
measure: Tolerability in view of the parents
time frame: After 4 months prevention
description: parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"
measure: Efficacy in the view of the parents/children
time frame: 4 months prevention
description: Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".
measure: accompanying virus analytics
time frame: 4 months prevention
description: nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses
measure: effects on the endogenous defense
time frame: 4 months prevention
description: Question will be asked " do you think that the prevention had the follwing effects on the endogenous defense in your child?" (unchanged; improved; significantly improved")
measure: Concomitant treatment and therapies
time frame: 4 months prevention
description: Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups
arm group label: Echinaforce Junior Tablets
arm group type: Experimental
description: Hydroalcoholic extract of Echinacea purpurea herb and radix
arm group label: Vitamin C Tablets
arm group type: Active Comparator
description: synthetically produced ascorbic acid
intervention type: Drug
intervention name: Echinaforce
arm group label: Echinaforce Junior Tablets
arm group label: Vitamin C Tablets
other name: Echinacea purpurea
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mercedes Ogal, Dr. med.
role: Principal Investigator
affiliation: Arztpraxis für Kinder und Jugendliche
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Infections
mesh term: Respiratory Tract Infections
mesh term: Virus Diseases
sharing ipd: No