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/NCT05995288</url>
    </required_header>
    <id_info>
      <org_study_id>202308</org_study_id>
      <nct_id>NCT05995288</nct_id>
    </id_info>
    <brief_title>Homeopathic Treatment of Children Suffering From PFAPA</brief_title>
    <acronym>HOMPFAPA</acronym>
    <official_title>Homeopathic Treatment of Children Suffering From PFAPA: a Retrospective Case Series.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michael Frass</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Vienna</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>
        Periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA) syndrome is&#xD;
        frequently diagnosed in young children. Fevers recurring at a nearly predictable rate every&#xD;
        three to eight weeks are the signature symptom of PFAPA syndrome. PFAPA is an acquired&#xD;
        autoinflammatory disorder, which recurs in association with at least one sign of aphthous&#xD;
        stomatitis, pharyngitis, and cervical lymph node enlargement. The aim of this retrospective&#xD;
        case report is to gain an impression of the course of disease during individualized&#xD;
        homeopathic treatment in children suffering from PFAPA.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this retrospective study, the investigators collected the history and symptoms of 13&#xD;
        consecutive PFAPA patients. The investigators also described the individually chosen&#xD;
        homeopathic medicinal products (HMPs) used, as well as the course of the disease. Clinical&#xD;
        outcome of case reports was assessed using the &quot;Modified Naranjo Criteria for&#xD;
        Homeopathy-Causal Attribution Inventory&quot;. Eight points are taken as the threshold for the&#xD;
        possible correlation between homeopathic therapy and improvement of symptoms or cure in&#xD;
        chronic cases&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2019</start_date>
    <completion_date type="Actual">August 8, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Periodic fever flares</measure>
      <time_frame>30 months</time_frame>
      <description>Appearance of periodic fever flares</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">13</enrollment>
    <condition>Periodic Fever Syndrome</condition>
    <arm_group>
      <arm_group_label>Children suffering from PFAPA</arm_group_label>
      <description>Children suffering from periodic fever, with at least one of the following symptoms: aphthous stomatitis, pharyngitis, cervical adenitis</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Homeopathic Globule</intervention_name>
      <description>Homeopathic globules were administered after careful anamnesis</description>
      <arm_group_label>Children suffering from PFAPA</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children were suffering from PFAPA for at least 6 months.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Children suffering from fever with at least one of the symptooms of PFAPA besides fever&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Parents not willing to sign informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Peter Panhofer, MD</last_name>
      <role>Study Director</role>
      <affiliation>Sigmund Freud Private University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Michael Frass</name>
        <address>
          <city>Wien</city>
          <zip>1100</zip>
          <country>Austria</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
      <investigator_full_name>Michael Frass</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>PFAPA</keyword>
    <keyword>periodic fever</keyword>
    <keyword>homeopathy</keyword>
    <keyword>Naranjo criteria</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Familial Mediterranean Fever</mesh_term>
    </condition_browse>
    <!-- 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/NCT05995288
  org study id: 202308
  nct id: NCT05995288
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA) syndrome is
        frequently diagnosed in young children. Fevers recurring at a nearly predictable rate every
        three to eight weeks are the signature symptom of PFAPA syndrome. PFAPA is an acquired
        autoinflammatory disorder, which recurs in association with at least one sign of aphthous
        stomatitis, pharyngitis, and cervical lymph node enlargement. The aim of this retrospective
        case report is to gain an impression of the course of disease during individualized
        homeopathic treatment in children suffering from PFAPA.
  In this retrospective study, the investigators collected the history and symptoms of 13
        consecutive PFAPA patients. The investigators also described the individually chosen
        homeopathic medicinal products (HMPs) used, as well as the course of the disease. Clinical
        outcome of case reports was assessed using the "Modified Naranjo Criteria for
        Homeopathy-Causal Attribution Inventory". Eight points are taken as the threshold for the
        possible correlation between homeopathic therapy and improvement of symptoms or cure in
        chronic cases
  observational model: Other
  time perspective: Retrospective
  measure: Periodic fever flares
  time frame: 30 months
  description: Appearance of periodic fever flares
  arm group label: Children suffering from PFAPA
  description: Children suffering from periodic fever, with at least one of the following symptoms: aphthous stomatitis, pharyngitis, cervical adenitis
  intervention type: Drug
  intervention name: Homeopathic Globule
  description: Homeopathic globules were administered after careful anamnesis
  arm group label: Children suffering from PFAPA
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 10 Years
  healthy volunteers: No
  last name: Peter Panhofer, MD
  role: Study Director
  affiliation: Sigmund Freud Private University
  facility: 
  country: Austria
  responsible party type: Sponsor-Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Michael Frass
  investigator title: MD
  mesh term: Familial Mediterranean Fever