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/NCT06002230</url>
    </required_header>
    <id_info>
      <org_study_id>111</org_study_id>
      <nct_id>NCT06002230</nct_id>
    </id_info>
    <brief_title>Use of Homeopathy in Patients Suffering From Long COVID-19</brief_title>
    <acronym>LONGCOVIHOM</acronym>
    <official_title>Use of Homeopathy in Patients Suffering From Long COVID-19 (LONGCOVIHOM): A Retrospective Case Series</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michael Frass</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sigmund Freud PrivatUniversitat</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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>
        In some patients, coronavirus (COVID-19) can cause symptoms that last weeks or even months&#xD;
        after the infection has gone. The aim of this study was to describe the effect of adjunctive&#xD;
        individualized homeopathic treatment delivered to Long-COVID-19 patients with previously&#xD;
        confirmed symptomatic SARS-CoV-2 infection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients had been tested positive for SARS-CoV-2 before having developed Long-COVID-19&#xD;
        symptoms. Several testing methods were carried out in each patient to analyze a SARS-CoV-2&#xD;
        infection. For a confirmed infection, at least 3 out of these 5 tests had to be positive.&#xD;
        Tests for the orthomyxoviruses influenza A and B, human metapneumovirus (hMPV) and&#xD;
        paramyxoviruses were negative unless stated otherwise.&#xD;
  &#xD;
        The homeopathic physician treated all Long-COVID-19 patients by individualized homeopathy.&#xD;
        Repertorization of the symptoms of the current pandemic and a search in the current&#xD;
        homeopathic literature on COVID-19 was performed using computer program. All available&#xD;
        homeopathic medicinal products (HMPs) could be chosen by the treating physician.&#xD;
  &#xD;
        Modified MONARCH criteria were assessed post hoc by all authors. Deviations were solved by&#xD;
        discussion in person. Clinical outcome of case reports was evaluated using the &quot;Modified&#xD;
        Naranjo Criteria for Homeopathy-Causal Attribution Inventory&quot;. Eight points is assumed as the&#xD;
        limit for potential correlation between homeopathic therapy and amelioration of the symptoms&#xD;
        or healing in chronic cases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 5, 2021</start_date>
    <completion_date type="Actual">August 10, 2023</completion_date>
    <primary_completion_date type="Actual">October 19, 2021</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Modified Naranjo criteria</measure>
      <time_frame>3 days</time_frame>
      <description>10 Naranjo criteria are evaluated, eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">15</enrollment>
    <condition>Adjustment Reaction With Physical Symptoms</condition>
    <arm_group>
      <arm_group_label>Patients treated with individualized homeopathy</arm_group_label>
      <description>Patients suffering from symptoms of Long COVID-19 were treated with individualized homeopathy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Homeopathic medicines</intervention_name>
      <description>Globules were administered orally..</description>
      <arm_group_label>Patients treated with individualized homeopathy</arm_group_label>
      <other_name>Homeopathic medicinal products</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients suffering from Long COVID-19 symptoms following recovery from SARS-CoV-2&#xD;
          infection.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Long COVID-19 symptoms following recovery from SARS-CoV-2 infection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients not signing informed consent&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Michael Frass, MD</last_name>
      <role>Study Director</role>
      <affiliation>Institute for Homeopathic Research</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Sigmund Freud Private University</name>
        <address>
          <city>Vienna</city>
          <zip>1020</zip>
          <country>Austria</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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>Clinical professor</investigator_title>
    </responsible_party>
    <keyword>Complementary therapy</keyword>
    <keyword>Homeopathy</keyword>
    <keyword>COVID-19</keyword>
    <keyword>Long-COVID-19</keyword>
    <keyword>SARS-CoV-2</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06002230
  org study id: 111
  nct id: NCT06002230
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In some patients, coronavirus (COVID-19) can cause symptoms that last weeks or even months
        after the infection has gone. The aim of this study was to describe the effect of adjunctive
        individualized homeopathic treatment delivered to Long-COVID-19 patients with previously
        confirmed symptomatic SARS-CoV-2 infection.
  All patients had been tested positive for SARS-CoV-2 before having developed Long-COVID-19
        symptoms. Several testing methods were carried out in each patient to analyze a SARS-CoV-2
        infection. For a confirmed infection, at least 3 out of these 5 tests had to be positive.
        Tests for the orthomyxoviruses influenza A and B, human metapneumovirus (hMPV) and
        paramyxoviruses were negative unless stated otherwise.
  
        The homeopathic physician treated all Long-COVID-19 patients by individualized homeopathy.
        Repertorization of the symptoms of the current pandemic and a search in the current
        homeopathic literature on COVID-19 was performed using computer program. All available
        homeopathic medicinal products (HMPs) could be chosen by the treating physician.
  
        Modified MONARCH criteria were assessed post hoc by all authors. Deviations were solved by
        discussion in person. Clinical outcome of case reports was evaluated using the "Modified
        Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points is assumed as the
        limit for potential correlation between homeopathic therapy and amelioration of the symptoms
        or healing in chronic cases.
  observational model: Cohort
  time perspective: Retrospective
  measure: Modified Naranjo criteria
  time frame: 3 days
  description: 10 Naranjo criteria are evaluated, eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.
  arm group label: Patients treated with individualized homeopathy
  description: Patients suffering from symptoms of Long COVID-19 were treated with individualized homeopathy.
  intervention type: Drug
  intervention name: Homeopathic medicines
  description: Globules were administered orally..
  arm group label: Patients treated with individualized homeopathy
  other name: Homeopathic medicinal products
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 100 Years
  last name: Michael Frass, MD
  role: Study Director
  affiliation: Institute for Homeopathic Research
  facility: 
  country: Austria
  responsible party type: Sponsor-Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Michael Frass
  investigator title: Clinical professor
  mesh term: COVID-19
  mesh term: Post-Acute COVID-19 Syndrome
  sharing ipd: Undecided