xml: <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/NCT06020001</url>
    </required_header>
    <id_info>
      <org_study_id>06-AP-COV</org_study_id>
      <nct_id>NCT06020001</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections</brief_title>
    <official_title>Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study was to assess the efficacy and safety of AP203 preparation (RESCOVIN®)&#xD;
        in a group of patients with increased incidence to viral and/or bacterial upper respiratory&#xD;
        tract infections.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Randomized, double-blind, cross over study conducted under medical supervision on 1) group of&#xD;
        30 patients receiving AP203 mixture in capsule form and 2) group of 30 receiving placebo.&#xD;
        After a washout period a group receiving placebo receiver AP203 mixture in syrup form.&#xD;
  &#xD;
        The study group was adult patients with an increased incidence of upper respiratory tract&#xD;
        infection. During the study, the effect of a mixture of AP203 extracts (RESCOVIN®) on markers&#xD;
        of inflammation and oxidative stress and the effect on the incidence of upper respiratory&#xD;
        tract infections was assessed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 14, 2022</start_date>
    <completion_date type="Actual">April 27, 2023</completion_date>
    <primary_completion_date type="Actual">April 27, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Efficacy and safety of AP203</measure>
      <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
      <description>Clinical evaluation of the efficacy and safety of AP203, in a group of patients with an increased incidence of viral and/or bacterial upper respiratory tract infections.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>hsCRP level</measure>
      <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
      <description>Comparison of hsCRP level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>8-iso-PGF2IsoP level</measure>
      <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
      <description>Comparison of 8-iso-PGF2IsoP level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cold Intensity Score</measure>
      <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
      <description>Comparison of Cold Intensity Score (CIS) values</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Upper Respiratory Tract Infection Bacterial</condition>
    <arm_group>
      <arm_group_label>AP203 mixture (RESCOVIN®) in capsule form</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with an increased incidence of upper respiratory tract infection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AP203 mixture (RESCOVIN®) in syrup form</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with an increased incidence of upper respiratory tract infection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients with an increased incidence of upper respiratory tract infection</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>AP203 mixture (RESCOVIN®)</intervention_name>
      <description>Polyphenol-rich plant extracts Twice a day</description>
      <arm_group_label>AP203 mixture (RESCOVIN®) in capsule form</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>AP203 mixture (RESCOVIN®)</intervention_name>
      <description>Polyphenol-rich plant extracts Twice a day</description>
      <arm_group_label>AP203 mixture (RESCOVIN®) in syrup form</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Twice a day</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women and men, 18-70 years old&#xD;
  &#xD;
            -  Healthy patients at the time of enrollment to the study (without active upper&#xD;
               respiratory tract infection)&#xD;
  &#xD;
            -  Presence of 2 or more episodes of upper respiratory tract infections or &gt;=2 episodes&#xD;
               of cold during the year&#xD;
  &#xD;
            -  Patients with chronic upper respiratory tract diseases including bronchial asthma&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
            -  Women: contraception or postmenopausal age&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intake of supplements containing plant extracts, polyphenols or anthocyanins for the 3&#xD;
               months prior to the study initiation&#xD;
  &#xD;
            -  Acute inflammation&#xD;
  &#xD;
            -  Oral immunosuppressive drugs&#xD;
  &#xD;
            -  Steroid, anti-allergic drugs in exacerbations of chronic disease at least 2 months&#xD;
               from the start of study participation&#xD;
  &#xD;
            -  Antibiotic therapy 1 month prior to study initiation&#xD;
  &#xD;
            -  Participation in another clinical trial;&#xD;
  &#xD;
            -  Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis,&#xD;
               leukaemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation;&#xD;
  &#xD;
            -  Hypersensitivity/allergy to any of the ingredients of the product, allergy to plants&#xD;
               of the Asteraceae family (e.g. chamomile, calendula);&#xD;
  &#xD;
            -  Women who are pregnant or planning to become pregnant during the study period;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko</name>
        <address>
          <city>Sopot</city>
          <zip>81-820</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Upper Respiratory Tract Infections</keyword>
    <keyword>Bacterial Infections</keyword>
    <keyword>Viral Infections</keyword>
    <keyword>RESCOVIN</keyword>
    <keyword>Plant extract</keyword>
    <keyword>Chokeberry extract</keyword>
    <keyword>Echinacea extract</keyword>
    <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>
      <mesh_term>Bacterial 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>
  
  
text: 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/NCT06020001
  org study id: 06-AP-COV
  nct id: NCT06020001
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study was to assess the efficacy and safety of AP203 preparation (RESCOVIN®)
        in a group of patients with increased incidence to viral and/or bacterial upper respiratory
        tract infections.
  Randomized, double-blind, cross over study conducted under medical supervision on 1) group of
        30 patients receiving AP203 mixture in capsule form and 2) group of 30 receiving placebo.
        After a washout period a group receiving placebo receiver AP203 mixture in syrup form.
  
        The study group was adult patients with an increased incidence of upper respiratory tract
        infection. During the study, the effect of a mixture of AP203 extracts (RESCOVIN®) on markers
        of inflammation and oxidative stress and the effect on the incidence of upper respiratory
        tract infections was assessed.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Efficacy and safety of AP203
  time frame: Baseline, 2 months, 4 months, 6 months
  description: Clinical evaluation of the efficacy and safety of AP203, in a group of patients with an increased incidence of viral and/or bacterial upper respiratory tract infections.
  measure: hsCRP level
  time frame: Baseline, 2 months, 4 months, 6 months
  description: Comparison of hsCRP level
  measure: 8-iso-PGF2IsoP level
  time frame: Baseline, 2 months, 4 months, 6 months
  description: Comparison of 8-iso-PGF2IsoP level
  measure: Cold Intensity Score
  time frame: Baseline, 2 months, 4 months, 6 months
  description: Comparison of Cold Intensity Score (CIS) values
  arm group label: AP203 mixture (RESCOVIN®) in capsule form
  arm group type: Experimental
  description: Patients with an increased incidence of upper respiratory tract infection
  arm group label: AP203 mixture (RESCOVIN®) in syrup form
  arm group type: Experimental
  description: Patients with an increased incidence of upper respiratory tract infection
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Patients with an increased incidence of upper respiratory tract infection
  intervention type: Dietary Supplement
  intervention name: AP203 mixture (RESCOVIN®)
  description: Polyphenol-rich plant extracts Twice a day
  arm group label: AP203 mixture (RESCOVIN®) in capsule form
  intervention type: Dietary Supplement
  intervention name: AP203 mixture (RESCOVIN®)
  description: Polyphenol-rich plant extracts Twice a day
  arm group label: AP203 mixture (RESCOVIN®) in syrup form
  intervention type: Other
  intervention name: Placebo
  description: Twice a day
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Respiratory Tract Infections
  mesh term: Bacterial Infections
  sharing ipd: No