<?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>IRCT20191124045488N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-29</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>effect of celery seed on obesity and fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>Survey the Effect of celery seed on serum levels of hepatic enzymes, lipid profile, glycemic parameters and hepatic steatosis degree in nonalcoholic fatty liver disease patients, with overweight and obesity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43736</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 44 subjects were divided into two groups of 22 intervention and control groups based on the block design method. In this way, an out-of-study third person who is familiar with health issues gives the supplement and placebo the same two codes as A and B. Subsequently, individuals are assigned AABB and BBAA. There are actually two 4-block blocks, each block having two A codes and two B codes. People are given codes in order to reach number 8, and repeat this number until they reach number 16. Then one of the blocks is repeated again to reach 20. Then the remaining two people receive a random code A or B code that reaches 22 people, Blinding description: In this study, the researcher and the participants are kept blind, and the third person oversees the intervention and control groups outside the study.</study_design>
      <phase>2</phase>
      <hc_freetext>Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: getting 4 capsule of celery seed (500mg) per day fo 6 weeks. Intervention 2: Control group: getting 4 capsules of plasebo for 6 weeks.</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 Due to the financial support of this research project by Ahvaz Jundishapur University of Medical Sciences, the study data will not be allowed to be published after the intervention.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Samadani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Boulevard, jundishapour university of medical sciences, Faculty of Paramedical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 71 3648 0181</telephone>
        <email>samadani.m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Mohammad Shahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Boulevard, jundishapour university of medical sciences, Faculty of Paramedical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 71 3648 0181</telephone>
        <email>mohamadshahi-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight and obese patients (with BMI&gt; 25)
With nonalcoholic fatty liver (grade 1, 2)
having ultrasound sheet with diagnosis of nonalcoholic fatty liver with radiologist and gastroenterologist approval</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
liver transplantation
cigarette smoking, alcohol and drugs use
medications such as corticosteroids, amiodarone, tamoxifen, pracacillin, methotrexate
complete intravenous nutrition
heart failure, kidney disease, thyroid failure
Hemochromatosis and Wilson disease
Having positive test for hepatitis C, B and autoimmune hepatitis
alpha-antitrypsin deficiency</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: getting 4 capsule of celery seed (500mg) per day fo 6 weeks.</i_keyword>
      <i_keyword>Control group: getting 4 capsules of plasebo for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hepatic enzymes (AST, ALT). Timepoint: Before and after intervention. Method of measurement: Use of enzymatic kits.</prim_outcome>
      <prim_outcome>Lipid profile (Triglyceride, total cholesterole, LDL, VLDL, HDL). Timepoint: Before and after intervention. Method of measurement: Use of enzymatic kits.</prim_outcome>
      <prim_outcome>Insulin levels. Timepoint: Before and after intervention. Method of measurement: Use of enzymatic kits.</prim_outcome>
      <prim_outcome>Liver Echogenicity. Timepoint: Before and after intervention. Method of measurement: Using an ultrasound machine by a radiologist.</prim_outcome>
      <prim_outcome>The total amount of calorie received. Timepoint: Before and after intervention. Method of measurement: Using a 24-hour food recording questionnaire.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: Before and after intervention. Method of measurement: Use of enzymatic kits.</prim_outcome>
      <prim_outcome>Body fat percentage. Timepoint: Before and after intervention. Method of measurement: Using body composition measuring device.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before and after intervention. Method of measurement: Using digital scales.</prim_outcome>
      <prim_outcome>Waist and hip circumference. Timepoint: Before and after intervention. Method of measurement: Use non-elastic tape meters.</prim_outcome>
      <prim_outcome>Fasting Blood sugar. Timepoint: Before and after intervention. Method of measurement: Use of enzymatic kits.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: Before and after intervention. Method of measurement: HOMA-IR=BS(mmol/lit)×insulin(microunit/lit)/22.5.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-23</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Faculty of Paramedical Sciences, Golestan Boulevard, Jundishapour University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
