<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20221018056221N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-18</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of the synergism effect of Xenogan capsule and Chlorella algae tablets with metformin and vitamin E in the treatment of patients with Non-alcoholic fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the synergism effect of Xenogan capsule and Chlorella algae tablets with metformin and vitamin E in the treatment of patients with Non-alcoholic fatty liver - a single-blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67354</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization will be done by the method of random permutation blocks using PASS 2011 software. In this way, using PASS 2011 software, in 15 permutation blocks, six members of the letters α β γ representing each of the treatment groups (for example αβγγβα) will be created by someone outside the research plan and will be placed in envelopes, then one of the envelopes will be randomly selected, and the task of the appointed groups of 6 people who will enter the study will be determined. This will continue until the full assignment of 90 patients to 3 study groups, Blinding description: The data analyst was kept blinded to the study group allocation.</study_design>
      <phase>2-3</phase>
      <hc_freetext>non alcohlic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: In the first intervention group, 1000 mg metformin tablets and 400 units of vitamin E capsules (pharmaceutical company...) are prescribed daily for 12 month. Intervention 2: In the second intervention group, two tablets (250 mg) of Zinogan capsules(Dorset Home Company) along with 1000 mg metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month. Intervention 3: In the third intervention group, three tablets (900 units) of Algomed chlorella algae tablets along (Steinberg Bioproduct Company) with 1000 mg of metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Shahab Bazvandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, parastar boulvarde</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3427 4618</telephone>
        <email>Bazvandishahab19@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. touraj Ahmadi Jouybari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, parastar boulvarde</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3427 4618</telephone>
        <email>Dr.ahmadi_jouybari@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent
Patients with fatty liver (grade 1-3)
High liver enzymes AST, ALT (more than 4-35 IU/L)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
being an alcoholic
History of biliary diseases, heart and blood vessels, liver diseases, kidney failure and bleeding peptic ulcer, types of cancer, thyroid
The presence of gastrointestinal ulcers
Taking any herbal supplements and vitamins</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of liver</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first intervention group, 1000 mg metformin tablets and 400 units of vitamin E capsules (pharmaceutical company...) are prescribed daily for 12 month.</i_keyword>
      <i_keyword>In the second intervention group, two tablets (250 mg) of Zinogan capsules(Dorset Home Company) along with 1000 mg metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month.</i_keyword>
      <i_keyword>In the third intervention group, three tablets (900 units) of Algomed chlorella algae tablets along (Steinberg Bioproduct Company) with 1000 mg of metformin tablets and 400 units of vitamin E capsules are prescribed daily for 12month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver enzymes (AST, ALT, ALP). Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
      <prim_outcome>Tri glyceride. Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
      <prim_outcome>Plasma insulin levels. Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
      <prim_outcome>Blood sugar. Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
      <prim_outcome>Bilirubin. Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
      <prim_outcome>Antioxidant level in blood serum. Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
      <prim_outcome>Serum albumin. Timepoint: The beginning of the study and the end of the twelfth week. Method of measurement: Using a blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-18</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
