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/NCT06011785</url>
    </required_header>
    <id_info>
      <org_study_id>HOHMF</org_study_id>
      <nct_id>NCT06011785</nct_id>
    </id_info>
    <brief_title>Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil</brief_title>
    <acronym>HOHM</acronym>
    <official_title>Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HOHM Foundation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>HOHM Foundation</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical study aims to address a research and clinical treatment gap related to&#xD;
        individuals with symptoms of Silicosis resulting from quartzite mining work. Silicosis&#xD;
        represents a challenge in this specific population in Sao Thome das Letras, Minas Gerais.&#xD;
        Silicosis is a severe disease and is considered incurable. Current conventional medicine only&#xD;
        offers palliative care for those with Silicosis, highlighting the important and urgent need&#xD;
        for research into complementary care approaches.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study design is a simple clinical trial to assess the effect of the homeopathic&#xD;
        medication Silica 12CH given alongside the conventional treatment of Silicosis, versus&#xD;
        standard treatment alone for Silicosis.&#xD;
  &#xD;
        The study design is a controlled non-blinded clinical study without randomization to test the&#xD;
        effectiveness of a homeopathic intervention among individuals with symptoms of Silicosis as a&#xD;
        result of working as quartzite miners. The intervention to be studied is a homeopathic&#xD;
        preparation of Silica 12CH on a sample of clients with Silicosis already receiving ongoing&#xD;
        conventional medical care. The intervention is Silica 12CH given over one year: a single dose&#xD;
        at intervals of three months (three times in the study period).&#xD;
  &#xD;
        Participants will be recruited locally through the clinic where they already receive ongoing&#xD;
        medical attention. The local secretary of health authorizes the release of the patient files.&#xD;
        Potential participants will be given printed information about the study details along with&#xD;
        information about how to participate and the associated deadlines for joining the study.&#xD;
        Interested individuals will be given the informed consent form.&#xD;
  &#xD;
        Participants will freely elect to be in either the control or intervention group. Individuals&#xD;
        in the control group follow the standard-care protocol without the homeopathic intervention.&#xD;
        Individuals in the experimental group will receive the homeopathic intervention while also&#xD;
        following the standard-care protocol. All individuals will be encouraged to continue with any&#xD;
        concurrent conventional medical treatment for their Silicosis-related symptoms. Individuals&#xD;
        in either group may freely leave the study at any time with no consequence. Additionally,&#xD;
        participants may freely elect to be moved from the control group into the experimental group&#xD;
        at the half-way point in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The study design is a controlled non-blinded clinical study without randomization to test the effectiveness of an intervention among individuals with symptoms of Silicosis as a result of working as quartzite miners. The intervention to be studied is a homeopathic preparation of Silica 12CH on a sample of clients with Silicosis already receiving ongoing conventional medical care. The intervention is Silica 12CH given over one year: a single dose at intervals of three months (three times in the study period).&#xD;
  Participants will be recruited locally through the clinic where they already receive ongoing medical attention. The local secretary of health authorizes the release of the patient files. Potential participants will be given printed information about the study details along with information about how to participate and the associated deadlines for joining the study. Interested individuals will be given the informed consent form.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking required.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in pulmonary health of individuals with Silicosis as assessed by symptoms '1' and '2' using the Measure Yourself Concerns and Wellbeing (MYCaW validated) wellness measurement instrument. 0 = As good as it can be. 6 = As bad as it can be</measure>
      <time_frame>One year</time_frame>
      <description>Monitor changes using validated wellness measurement instrument</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in pulmonary health of individuals with Silicosis as assessed by overall wellness scores using the Measure Yourself Concerns and Wellbeing (MYCaW validated) wellness measurement instrument. 0 = As good as it can be. 6 = As bad as it can be.</measure>
      <time_frame>One year</time_frame>
      <description>Monitor changes using validated wellness measurement instrument</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Silicosis</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants have Silicosis and wish to be included in the intervention group</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Silica 12CH</intervention_name>
      <description>Participants will freely elect to be in either the intervention group. Individuals in the experimental group will receive the intervention while also following the standard-care protocol. All individuals will be encouraged to continue with any concurrent conventional medical treatment for their Silicosis-related symptoms. Individuals in either group may freely leave the study at any time with no consequence. Additionally, participants may freely elect to decide opt out at any time.</description>
      <arm_group_label>Intervention Group</arm_group_label>
      <other_name>Silicea terra (sil)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be eligible to participate, participants must meet the following criteria:&#xD;
  &#xD;
                 -  must be at least 18 years old&#xD;
  &#xD;
                 -  must have a clinical diagnosis of silicosis&#xD;
  &#xD;
                 -  must be receiving conventional medical care and/or monitoring for their condition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ● Individuals under the age of 18&#xD;
  &#xD;
                 -  individuals who are not receiving conventional medical care and/or monitoring for&#xD;
                    their condition&#xD;
  &#xD;
                 -  individuals too infirm to receive regular monitoring as required for the study&#xD;
  &#xD;
                 -  Interested participants without Silicosis&#xD;
  &#xD;
                 -  Individuals with Tuberculosis&#xD;
  &#xD;
                 -  Individuals defined as part of a vulnerable group&#xD;
  &#xD;
                      -  legal or clinically incapable persons&#xD;
  &#xD;
                      -  person in a state of temporary disability;&#xD;
  &#xD;
                      -  of a member of indigenous community&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alastair C Gray, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>HOHM Foundation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alastair C Gray, PhD</last_name>
      <phone>+13478192417</phone>
      <email>alastair.gray@hohmfoundation.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Parker Pracjek, MA</last_name>
      <phone>+573203671782</phone>
      <email>parker.pracjek@hohmfoundation.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>HOHM Foundation</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19138</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alastair C Gray, PhD</last_name>
        <phone>347-819-2417</phone>
        <email>alastair.gray@hohmfoundation.org</email>
      </contact>
      <contact_backup>
        <last_name>Parker Pracjek, MA</last_name>
        <phone>+573203671782</phone>
        <email>parker.pracjek@hohmfoundation.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Souza TP, Watte G, Gusso AM, Souza R, Moreira JDS, Knorst MM. Silicosis prevalence and risk factors in semi-precious stone mining in Brazil. Am J Ind Med. 2017 Jun;60(6):529-536. doi: 10.1002/ajim.22719.</citation>
      <PMID>28514023</PMID>
    </results_reference>
    <results_reference>
      <citation>Souza TP, van Tongeren M, Monteiro I. Respiratory health and silicosis in artisanal mine workers in southern Brazil. Am J Ind Med. 2021 Jun;64(6):511-518. doi: 10.1002/ajim.23242. Epub 2021 Mar 28.</citation>
      <PMID>33774816</PMID>
    </results_reference>
    <results_reference>
      <citation>Carneiro AP, Braz NF, Algranti E, Bezerra OM, Araujo NP, Amaral Eng Hyg LS, Edme JL, Sobaszek A, Cherot-Kornobis N. Silica exposure and disease in semi-precious stone craftsmen, Minas Gerais, Brazil. Am J Ind Med. 2017 Mar;60(3):239-247. doi: 10.1002/ajim.22682.</citation>
      <PMID>28195659</PMID>
    </results_reference>
    <results_reference>
      <citation>Goyal KK. Two cases of pulmonary TB treated with homeopathy. Homeopathy. 2002 Jan;91(1):43-6. doi: 10.1054/homp.2001.0009. No abstract available.</citation>
      <PMID>12371452</PMID>
    </results_reference>
    <results_reference>
      <citation>Chand KS, Manchanda RK, Mittal R, Batra S, Banavaliker JN, De I. Homeopathic treatment in addition to standard care in multi drug resistant pulmonary tuberculosis: a randomized, double blind, placebo controlled clinical trial. Homeopathy. 2014 Apr;103(2):97-107. doi: 10.1016/j.homp.2013.12.003. Erratum In: Homeopathy. 2015 Jul;104(3):163.</citation>
      <PMID>24685414</PMID>
    </results_reference>
    <results_reference>
      <citation>Hoeper MM, Welte T. Systemic inflammation, COPD, and pulmonary hypertension. Chest. 2007 Feb;131(2):634-5; author reply 635. doi: 10.1378/chest.06-2207. No abstract available.</citation>
      <PMID>17296674</PMID>
    </results_reference>
    <results_reference>
      <citation>Boccolini PMM, de Lima Sirio Boclin K, de Sousa IMC, Boccolini CS. Prevalence of complementary and alternative medicine use in Brazil: results of the National Health Survey, 2019. BMC Complement Med Ther. 2022 Aug 2;22(1):205. doi: 10.1186/s12906-022-03687-x.</citation>
      <PMID>35918725</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>HOHM Foundation</investigator_affiliation>
      <investigator_full_name>Alastair Gray</investigator_full_name>
      <investigator_title>Director Research</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Silicosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Survey data will be collected and stored using Alchemer before being transferred to Excel. Only the Principal Investigators will have access to this data at the conclusion of the data collection portion of the study. This information will then be stored on a password protected secure file. It will not be printed or shared with anyone else for any purpose.&#xD;
  The only research personnel who will have authority to use or have access to the information are the Principal (Alastair Gray) and Co-Investigator (Parker Pracjek).</ipd_description>
    </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/NCT06011785
  org study id: HOHMF
  nct id: NCT06011785
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This clinical study aims to address a research and clinical treatment gap related to
        individuals with symptoms of Silicosis resulting from quartzite mining work. Silicosis
        represents a challenge in this specific population in Sao Thome das Letras, Minas Gerais.
        Silicosis is a severe disease and is considered incurable. Current conventional medicine only
        offers palliative care for those with Silicosis, highlighting the important and urgent need
        for research into complementary care approaches.
  The study design is a simple clinical trial to assess the effect of the homeopathic
        medication Silica 12CH given alongside the conventional treatment of Silicosis, versus
        standard treatment alone for Silicosis.
  
        The study design is a controlled non-blinded clinical study without randomization to test the
        effectiveness of a homeopathic intervention among individuals with symptoms of Silicosis as a
        result of working as quartzite miners. The intervention to be studied is a homeopathic
        preparation of Silica 12CH on a sample of clients with Silicosis already receiving ongoing
        conventional medical care. The intervention is Silica 12CH given over one year: a single dose
        at intervals of three months (three times in the study period).
  
        Participants will be recruited locally through the clinic where they already receive ongoing
        medical attention. The local secretary of health authorizes the release of the patient files.
        Potential participants will be given printed information about the study details along with
        information about how to participate and the associated deadlines for joining the study.
        Interested individuals will be given the informed consent form.
  
        Participants will freely elect to be in either the control or intervention group. Individuals
        in the control group follow the standard-care protocol without the homeopathic intervention.
        Individuals in the experimental group will receive the homeopathic intervention while also
        following the standard-care protocol. All individuals will be encouraged to continue with any
        concurrent conventional medical treatment for their Silicosis-related symptoms. Individuals
        in either group may freely leave the study at any time with no consequence. Additionally,
        participants may freely elect to be moved from the control group into the experimental group
        at the half-way point in the study.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The study design is a controlled non-blinded clinical study without randomization to test the effectiveness of an intervention among individuals with symptoms of Silicosis as a result of working as quartzite miners. The intervention to be studied is a homeopathic preparation of Silica 12CH on a sample of clients with Silicosis already receiving ongoing conventional medical care. The intervention is Silica 12CH given over one year: a single dose at intervals of three months (three times in the study period).
  Participants will be recruited locally through the clinic where they already receive ongoing medical attention. The local secretary of health authorizes the release of the patient files. Potential participants will be given printed information about the study details along with information about how to participate and the associated deadlines for joining the study. Interested individuals will be given the informed consent form.
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: No masking required.
  measure: Changes in pulmonary health of individuals with Silicosis as assessed by symptoms '1' and '2' using the Measure Yourself Concerns and Wellbeing (MYCaW validated) wellness measurement instrument. 0 = As good as it can be. 6 = As bad as it can be
  time frame: One year
  description: Monitor changes using validated wellness measurement instrument
  measure: Changes in pulmonary health of individuals with Silicosis as assessed by overall wellness scores using the Measure Yourself Concerns and Wellbeing (MYCaW validated) wellness measurement instrument. 0 = As good as it can be. 6 = As bad as it can be.
  time frame: One year
  description: Monitor changes using validated wellness measurement instrument
  arm group label: Intervention Group
  arm group type: Experimental
  description: Participants have Silicosis and wish to be included in the intervention group
  intervention type: Drug
  intervention name: Silica 12CH
  description: Participants will freely elect to be in either the intervention group. Individuals in the experimental group will receive the intervention while also following the standard-care protocol. All individuals will be encouraged to continue with any concurrent conventional medical treatment for their Silicosis-related symptoms. Individuals in either group may freely leave the study at any time with no consequence. Additionally, participants may freely elect to decide opt out at any time.
  arm group label: Intervention Group
  other name: Silicea terra (sil)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Alastair C Gray, PhD
  role: Principal Investigator
  affiliation: HOHM Foundation
  last name: Alastair C Gray, PhD
  phone: +13478192417
  email: alastair.gray@hohmfoundation.org
  last name: Parker Pracjek, MA
  phone: +573203671782
  email: parker.pracjek@hohmfoundation.org
  facility: 
  contact: 
  contact backup: 
  country: United States
  citation: Souza TP, Watte G, Gusso AM, Souza R, Moreira JDS, Knorst MM. Silicosis prevalence and risk factors in semi-precious stone mining in Brazil. Am J Ind Med. 2017 Jun;60(6):529-536. doi: 10.1002/ajim.22719.
  PMID: 28514023
  citation: Souza TP, van Tongeren M, Monteiro I. Respiratory health and silicosis in artisanal mine workers in southern Brazil. Am J Ind Med. 2021 Jun;64(6):511-518. doi: 10.1002/ajim.23242. Epub 2021 Mar 28.
  PMID: 33774816
  citation: Carneiro AP, Braz NF, Algranti E, Bezerra OM, Araujo NP, Amaral Eng Hyg LS, Edme JL, Sobaszek A, Cherot-Kornobis N. Silica exposure and disease in semi-precious stone craftsmen, Minas Gerais, Brazil. Am J Ind Med. 2017 Mar;60(3):239-247. doi: 10.1002/ajim.22682.
  PMID: 28195659
  citation: Goyal KK. Two cases of pulmonary TB treated with homeopathy. Homeopathy. 2002 Jan;91(1):43-6. doi: 10.1054/homp.2001.0009. No abstract available.
  PMID: 12371452
  citation: Chand KS, Manchanda RK, Mittal R, Batra S, Banavaliker JN, De I. Homeopathic treatment in addition to standard care in multi drug resistant pulmonary tuberculosis: a randomized, double blind, placebo controlled clinical trial. Homeopathy. 2014 Apr;103(2):97-107. doi: 10.1016/j.homp.2013.12.003. Erratum In: Homeopathy. 2015 Jul;104(3):163.
  PMID: 24685414
  citation: Hoeper MM, Welte T. Systemic inflammation, COPD, and pulmonary hypertension. Chest. 2007 Feb;131(2):634-5; author reply 635. doi: 10.1378/chest.06-2207. No abstract available.
  PMID: 17296674
  citation: Boccolini PMM, de Lima Sirio Boclin K, de Sousa IMC, Boccolini CS. Prevalence of complementary and alternative medicine use in Brazil: results of the National Health Survey, 2019. BMC Complement Med Ther. 2022 Aug 2;22(1):205. doi: 10.1186/s12906-022-03687-x.
  PMID: 35918725
  responsible party type: Principal Investigator
  investigator affiliation: HOHM Foundation
  investigator full name: Alastair Gray
  investigator title: Director Research
  mesh term: Silicosis
  sharing ipd: No
  ipd description: Survey data will be collected and stored using Alchemer before being transferred to Excel. Only the Principal Investigators will have access to this data at the conclusion of the data collection portion of the study. This information will then be stored on a password protected secure file. It will not be printed or shared with anyone else for any purpose.
  The only research personnel who will have authority to use or have access to the information are the Principal (Alastair Gray) and Co-Investigator (Parker Pracjek).