<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/NCT03812900</url>
  </required_header>
  <id_info>
    <org_study_id>5'000'155</org_study_id>
    <nct_id>NCT03812900</nct_id>
  </id_info>
  <brief_title>Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections</brief_title>
  <official_title>Comparative, Conceptual, Randomized Clinical Study to Investigate Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Acute Symptoms of Respiratory Tract Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>A. Vogel AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cantonal Hospital of St. Gallen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Labormedizinisches Zentrum Dr. Risch</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>A. Vogel AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a comparative, conceptual, randomized clinical study to investigate newly developed&#xD;
      over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract&#xD;
      infections. 400 adults will be recruited, of which approximately 300 will develop a common&#xD;
      cold or a influenza-like infection. Two newly developed and two existing Echinacea&#xD;
      formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal&#xD;
      3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days&#xD;
      or until symptom resolution. Nasopharynx samples will be collected for analysis of common&#xD;
      viral respiratory agents throughout treatment. Safety and efficacy variables will be&#xD;
      assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The monocentre trial compares two newly developed pharmaceutical forms of Echinacea (extract&#xD;
      from Echinacea purpurea Herba and Radix; lozenges or spray) with two basic and authorised&#xD;
      pharmaceutical forms (tablets or drops; comparator groups) for the treatment of acute&#xD;
      symptoms of the common cold and/or influenza-like illness (ILI) in adults. Trial subjects are&#xD;
      preventatively screened and included in the study (n = 400). If they show acute symptoms of a&#xD;
      common cold or ILI during the study period, they are instructed to call the study centre to&#xD;
      have confirmed the indication for treatment and begin with the treatment, they are randomized&#xD;
      to (1:1:1:1 randomization into one of four groups). The primary endpoint is the time until&#xD;
      remission of respiratory symptoms with the new pharmaceutical forms compared to the basic&#xD;
      forms during the first episode. Secondary endpoints include remission of all treated episodes&#xD;
      (max. 3 episodes), remission times comparison between different pharmaceutical forms (e.g.&#xD;
      lozenges vs. spray, lozenges vs. drops etc), reduction of viral load on day 5 and 9 compared&#xD;
      to day 1 of treatment (nasopharyngeal swabs), differences in safety (blood parameters before&#xD;
      and during treatment), differences in number of adverse events, tolerance and efficacy&#xD;
      assessed by the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">June 7, 2019</completion_date>
  <primary_completion_date type="Actual">June 5, 2019</primary_completion_date>
  <phase>Phase 2/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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to remission from initial episodes</measure>
    <time_frame>maximally 10 days</time_frame>
    <description>duration until respiratory symptoms are solved</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to remission from overall episodes</measure>
    <time_frame>maximally 10 days</time_frame>
    <description>duration until respiratory symptoms are solved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cross-comparison of remissions between formulations</measure>
    <time_frame>maximally 10 days</time_frame>
    <description>duration until respiratory symptoms are solved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of single respiratory symptoms</measure>
    <time_frame>maximally 10 days</time_frame>
    <description>Comparison of respiratory symptom scores between formulations, adapted Jackson Score [0-3, 0=absent, 3=severe]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of respiratory symptom sum score</measure>
    <time_frame>maximally 10 days</time_frame>
    <description>Comparison of symptom sum scores between formulations, adapted Jackson Score [0-27, each 0=absent, 3=severe]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absence from School/Work</measure>
    <time_frame>during acute respiratory episodes, 7 days each</time_frame>
    <description>Number of days absent from work or school</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of viral load in nasopharyngeal samples</measure>
    <time_frame>day 1, day 5, day 9</time_frame>
    <description>Comparison of virus titer at day 5 and 9 i.c. to day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of efficacy by patient</measure>
    <time_frame>At end of treatment cycle of 10 days</time_frame>
    <description>Comparisons of subjective efficacy assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood safety (red and white cell count)</measure>
    <time_frame>At Inclusion visit and day 5 of infection</time_frame>
    <description>Change of blood parameters before (V1) and after treatment (V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood safety (creatinin [umol/l])</measure>
    <time_frame>At Inclusion visit and day 5 of infection</time_frame>
    <description>Change of blood parameters before (V1) and after treatment (V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood safety (ALT [ukat/l])</measure>
    <time_frame>At Inclusion visit and day 5 of infection</time_frame>
    <description>Change of blood parameters before (V1) and after treatment (V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood safety (AST [ukat/l])</measure>
    <time_frame>At Inclusion visit and day 5 of infection</time_frame>
    <description>Change of blood parameters before (V1) and after treatment (V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood safety (Bilirubin [umol/l])</measure>
    <time_frame>At Inclusion visit and day 5 of infection</time_frame>
    <description>Change of blood parameters before (V1) and after treatment (V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of treatment</measure>
    <time_frame>At end of treatment cycle of 10 days</time_frame>
    <description>Question:&quot;would you use the medicament again?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant medication and -therapy</measure>
    <time_frame>during acute respiratory episodes of 10 days</time_frame>
    <description>Incidence of concomitant medication and -therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>during acute respiratory episodes, from day 1 until follow up at day 17 - 21</time_frame>
    <description>occurrence of adverse events during treatment with Echinacea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of tolerability by patient</measure>
    <time_frame>At day 10 of every treatment cycle</time_frame>
    <description>Comparisons of subjective tolerability assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re tolerability.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">246</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Formulation A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Echinacea purpurea alcoholic extract lozenges (novel formulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Echinacea purpurea alcoholic extract spray (novel formulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Echinacea purpurea alcoholic extract tablet (basic formulation, reference)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Echinacea purpurea alcoholic extract, drops (basic formulation, reference)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Echinacea purpurea alcoholic extract</intervention_name>
    <description>Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)</description>
    <arm_group_label>Formulation A</arm_group_label>
    <arm_group_label>Formulation B</arm_group_label>
    <arm_group_label>Formulation C</arm_group_label>
    <arm_group_label>Formulation D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years&#xD;
&#xD;
          -  Participation in another clinical study in the past 30 days&#xD;
&#xD;
          -  Permanent intake of antimicrobial, antiviral, immune suppressive substances&#xD;
&#xD;
          -  Surgical intervention in the 3 months prior to inclusion or planned surgery during&#xD;
             period of observation&#xD;
&#xD;
          -  Known diabetes melitus&#xD;
&#xD;
          -  Known and treated atopy or asthma bronchiale&#xD;
&#xD;
          -  Cystic fibrosis, bronchopulmonale dysplasia, COPD&#xD;
&#xD;
          -  Known diseases of the immune system, degenerative illnesses (e.g. auto-immune&#xD;
             disorders like AIDS or leukemia, myeloma)&#xD;
&#xD;
          -  Known metabolic or resorptive disorders&#xD;
&#xD;
          -  Known chronic liver diseases (chronic hepatitis, liver cirrhosis)&#xD;
&#xD;
          -  Known chronic kidney insufficiency&#xD;
&#xD;
          -  Serious health issues (reduced health status, autoimmune illness, tumorous illness)&#xD;
&#xD;
          -  Known allergy to plants of compositae family (camomille, dandelion) or to any&#xD;
             substances of the investigational product&#xD;
&#xD;
          -  At inclusion known pregnancy or planned pregnancy during period of investigation&#xD;
             (required: active contraception for women of childbearing year)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cantonal Hospital St. Gallen</name>
      <address>
        <city>Saint Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</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>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</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/NCT03812900
org study id: 5'000'155
nct id: NCT03812900
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a comparative, conceptual, randomized clinical study to investigate newly developed
      over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract
      infections. 400 adults will be recruited, of which approximately 300 will develop a common
      cold or a influenza-like infection. Two newly developed and two existing Echinacea
      formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal
      3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days
      or until symptom resolution. Nasopharynx samples will be collected for analysis of common
      viral respiratory agents throughout treatment. Safety and efficacy variables will be
      assessed.
The monocentre trial compares two newly developed pharmaceutical forms of Echinacea (extract
      from Echinacea purpurea Herba and Radix; lozenges or spray) with two basic and authorised
      pharmaceutical forms (tablets or drops; comparator groups) for the treatment of acute
      symptoms of the common cold and/or influenza-like illness (ILI) in adults. Trial subjects are
      preventatively screened and included in the study (n = 400). If they show acute symptoms of a
      common cold or ILI during the study period, they are instructed to call the study centre to
      have confirmed the indication for treatment and begin with the treatment, they are randomized
      to (1:1:1:1 randomization into one of four groups). The primary endpoint is the time until
      remission of respiratory symptoms with the new pharmaceutical forms compared to the basic
      forms during the first episode. Secondary endpoints include remission of all treated episodes
      (max. 3 episodes), remission times comparison between different pharmaceutical forms (e.g.
      lozenges vs. spray, lozenges vs. drops etc), reduction of viral load on day 5 and 9 compared
      to day 1 of treatment (nasopharyngeal swabs), differences in safety (blood parameters before
      and during treatment), differences in number of adverse events, tolerance and efficacy
      assessed by the patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time to remission from initial episodes
time frame: maximally 10 days
description: duration until respiratory symptoms are solved
measure: Time to remission from overall episodes
time frame: maximally 10 days
description: duration until respiratory symptoms are solved
measure: Cross-comparison of remissions between formulations
time frame: maximally 10 days
description: duration until respiratory symptoms are solved
measure: Development of single respiratory symptoms
time frame: maximally 10 days
description: Comparison of respiratory symptom scores between formulations, adapted Jackson Score [0-3, 0=absent, 3=severe]
measure: Development of respiratory symptom sum score
time frame: maximally 10 days
description: Comparison of symptom sum scores between formulations, adapted Jackson Score [0-27, each 0=absent, 3=severe]
measure: Absence from School/Work
time frame: during acute respiratory episodes, 7 days each
description: Number of days absent from work or school
measure: Reduction of viral load in nasopharyngeal samples
time frame: day 1, day 5, day 9
description: Comparison of virus titer at day 5 and 9 i.c. to day 1
measure: Subjective assessment of efficacy by patient
time frame: At end of treatment cycle of 10 days
description: Comparisons of subjective efficacy assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re efficacy.
measure: Blood safety (red and white cell count)
time frame: At Inclusion visit and day 5 of infection
description: Change of blood parameters before (V1) and after treatment (V2)
measure: Blood safety (creatinin [umol/l])
time frame: At Inclusion visit and day 5 of infection
description: Change of blood parameters before (V1) and after treatment (V2)
measure: Blood safety (ALT [ukat/l])
time frame: At Inclusion visit and day 5 of infection
description: Change of blood parameters before (V1) and after treatment (V2)
measure: Blood safety (AST [ukat/l])
time frame: At Inclusion visit and day 5 of infection
description: Change of blood parameters before (V1) and after treatment (V2)
measure: Blood safety (Bilirubin [umol/l])
time frame: At Inclusion visit and day 5 of infection
description: Change of blood parameters before (V1) and after treatment (V2)
measure: Acceptance of treatment
time frame: At end of treatment cycle of 10 days
description: Question:"would you use the medicament again?"
measure: Concomitant medication and -therapy
time frame: during acute respiratory episodes of 10 days
description: Incidence of concomitant medication and -therapy
measure: adverse events
time frame: during acute respiratory episodes, from day 1 until follow up at day 17 - 21
description: occurrence of adverse events during treatment with Echinacea
measure: Subjective assessment of tolerability by patient
time frame: At day 10 of every treatment cycle
description: Comparisons of subjective tolerability assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re tolerability.
arm group label: Formulation A
arm group type: Experimental
description: Echinacea purpurea alcoholic extract lozenges (novel formulation)
arm group label: Formulation B
arm group type: Experimental
description: Echinacea purpurea alcoholic extract spray (novel formulation)
arm group label: Formulation C
arm group type: Active Comparator
description: Echinacea purpurea alcoholic extract tablet (basic formulation, reference)
arm group label: Formulation D
arm group type: Active Comparator
description: Echinacea purpurea alcoholic extract, drops (basic formulation, reference)
intervention type: Drug
intervention name: Echinacea purpurea alcoholic extract
description: Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)
arm group label: Formulation A
arm group label: Formulation B
arm group label: Formulation C
arm group label: Formulation D
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
sharing ipd: No