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/NCT05966025</url>
    </required_header>
    <id_info>
      <org_study_id>REC-H-PhBSU-23006</org_study_id>
      <nct_id>NCT05966025</nct_id>
    </id_info>
    <brief_title>Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)</brief_title>
    <acronym>MAFLD</acronym>
    <official_title>Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>October 6 University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>October 6 University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</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>
        Objective of this study is to determine the clinical benefits of itopride in improvement of&#xD;
        MAFLD&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        the study will evaluate the possible benefits of itopride when added to pateints with&#xD;
        metabolic associated fatty liver disease&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>Phase 2</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>incidence of MAFLD</measure>
      <time_frame>&quot;1 Year &quot;</time_frame>
      <description>Highly sensitive CRP in mg\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\liter by blood test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of mafld</measure>
      <time_frame>&quot; 1 Year&quot;</time_frame>
      <description>Decrease LDL in mg\dl, Triglyceride and total cholesterolin mg\dl ,HOMA-IR in mg\dl, IL6,TNF alpha in mg\l by eliza</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Fatty Liver Disease</condition>
    <condition>Fatty Liver</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>interventions: drug itopride</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Itopride</intervention_name>
      <description>itopride will be taken by pateints one time per day by dose 100 mg</description>
      <arm_group_label>interventions: drug itopride</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>conventional therapy</intervention_name>
      <description>will taken by patient in control group</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>interventions: drug itopride</arm_group_label>
      <other_name>Anti hypertensive druds, anti hyperlipidemic drugs</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography&#xD;
               and laboratory tests for liver and lipids. - -&#xD;
  &#xD;
            -  Patients with comorbidites like hypertension,diabetes,dyslipidemia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria included the presence of liver disease due to any of the following:&#xD;
               viral hepatitis (HBV, HCV)&#xD;
  &#xD;
            -  acute systemic disease&#xD;
  &#xD;
            -  cystic fibrosis, coeliac disease&#xD;
  &#xD;
            -  suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency&#xD;
  &#xD;
            -  metabolic inherited diseases&#xD;
  &#xD;
            -  autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g.&#xD;
               valproate, amiodarone orprednisone).&#xD;
  &#xD;
            -  Patients were also excluded if body weight and carbohydrate metabolism were altered by&#xD;
               the use of parenteral nutrition&#xD;
  &#xD;
            -  protein malnutrition&#xD;
  &#xD;
            -  previous gastrointestinal surgery&#xD;
  &#xD;
            -  structural abnormalitiesof the gastrointestinal tract or neurological impairment.&#xD;
  &#xD;
            -  the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1&#xD;
  &#xD;
            -  probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months&#xD;
               preceding enrolmentwere also considered exclusion criteria.&#xD;
  &#xD;
            -  Patient with age below 18 or above 60&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hoda m rabea, A Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beni-suaf university</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yasmine m madney, Lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beni-suaf university</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maha y fekry, beclore</last_name>
      <phone>01111349592</phone>
      <phone_ext>october 6</phone_ext>
      <email>maha.youssif.ph@o6u.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Engy ah wahsh, Lecturer</last_name>
      <phone>01003095692</phone>
      <phone_ext>october 6</phone_ext>
      <email>engywahsh@o6u.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Maha Youssif Fekry</name>
        <address>
          <city>Giza</city>
          <zip>12573</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>maha y fekry, beclore</last_name>
        <phone>01111349592</phone>
        <phone_ext>october6</phone_ext>
        <email>maha.youssif.ph@o6u.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Engy ah wahsh, lec o6u</last_name>
        <phone>01003095692</phone>
        <phone_ext>october6</phone_ext>
        <email>engywahsh@o6u.edu.eg</email>
      </contact_backup>
      <investigator>
        <last_name>Hoda m Rabea, A professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yasmine m medney, lec</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 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>Principal Investigator</responsible_party_type>
      <investigator_affiliation>October 6 University</investigator_affiliation>
      <investigator_full_name>Maha youssif</investigator_full_name>
      <investigator_title>Maha Youssif Fekry</investigator_title>
    </responsible_party>
    <keyword>Itopride in Mafld</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antihypertensive Agents</mesh_term>
      <mesh_term>Hypolipidemic Agents</mesh_term>
    </intervention_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/NCT05966025
  org study id: REC-H-PhBSU-23006
  nct id: NCT05966025
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Objective of this study is to determine the clinical benefits of itopride in improvement of
        MAFLD
  the study will evaluate the possible benefits of itopride when added to pateints with
        metabolic associated fatty liver disease
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: incidence of MAFLD
  time frame: "1 Year "
  description: Highly sensitive CRP in mg\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\liter by blood test
  measure: Incidence of mafld
  time frame: " 1 Year"
  description: Decrease LDL in mg\dl, Triglyceride and total cholesterolin mg\dl ,HOMA-IR in mg\dl, IL6,TNF alpha in mg\l by eliza
  arm group label: control group
  arm group type: Experimental
  description: • control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
  arm group label: interventions: drug itopride
  arm group type: Experimental
  description: • itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy
  intervention type: Drug
  intervention name: Itopride
  description: itopride will be taken by pateints one time per day by dose 100 mg
  arm group label: interventions: drug itopride
  intervention type: Drug
  intervention name: conventional therapy
  description: will taken by patient in control group
  arm group label: control group
  arm group label: interventions: drug itopride
  other name: Anti hypertensive druds, anti hyperlipidemic drugs
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Hoda m rabea, A Professor
  role: Principal Investigator
  affiliation: Beni-suaf university
  last name: Yasmine m madney, Lecturer
  role: Principal Investigator
  affiliation: Beni-suaf university
  last name: Maha y fekry, beclore
  phone: 01111349592
  phone ext: october 6
  email: maha.youssif.ph@o6u.edu.eg
  last name: Engy ah wahsh, Lecturer
  phone: 01003095692
  phone ext: october 6
  email: engywahsh@o6u.edu.eg
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: October 6 University
  investigator full name: Maha youssif
  investigator title: Maha Youssif Fekry
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Antihypertensive Agents
  mesh term: Hypolipidemic Agents