<?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>IRCT201701162709N39</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-06</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Iran university Medical Sciences</primary_sponsor>
      <public_title>The effect of sumacl on fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supplementation with sumac powder on liver enzymes (Alanine aminotransferase and Aspartate  aminotransferase ), lipid profiles(Triglyceride,Total cholestrol,High density lipoprotein,Low density lipoprotein)، leptin and liver steatosis in patients with non-alcoholic fatty liver disease: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2550</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Control group: daily 2 g dextrin as 4 capsules of 500 mg. Intervention 2: Intervention group: daily 2 g sumac as 4 capsules of 500 mg.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Farzad Shidfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health,Iran University Medical Sciences,The intersection of Sheikh Fazllolallah and shahid Chamran,Hemmat Highway,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8670 4743</telephone>
        <email>Shidfar.f@iums.ac.ir, farzadshidfar@yahoo.com, siminehsani@ymail.com</email>
        <affiliation>Iran University Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farzad Shidfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health,Iran University Medical Sciences,The intersection of Sheikh Fazllolallah and shahid Chamran,Hemmat Highway,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8670 4743</telephone>
        <email>Shidfar.f@iums.ac.ir, farzadshidfar@yahoo.com, siminehsani@ymail.com</email>
        <affiliation>Iran University Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The criteria for inclusion: Age 20-60 years of both sexes, fatty liver disease be approved by physician gastroenterologist based on the following criteria: (ultrasound, volume Alastvmtry in fiberscan  and&gt; 4 kPa (kpa) or are in the process of steatosis S1 and Alanine transferase more than 5.1 times the upper limit of normal (women and men),  Body Mass Index (BMI)25-29/9),  a interested in participating the plan and received written informed consent,  lack of participation in other projects.&#13;
Exclusion criteria:The patient's unwillingness to continue cooperation with the&#13;
Started taking the drug during the intervening period, Change the type or dose, Change in diet or physical activity program, Weight loss more than 10% of initial body weight during the intervention , Any use of antioxidant supplements, vitamins or minerals , Less than 80% supplements delivered to the patient at baseline, Start smoking during the intervening period, Become pregnant during treatment, Surgery and psychosomatic problems during the intervention, The use of all anti-NASH (vitamin E, thiazolidinedione, UDCA gemfibrozil,), Developing other liver diseases, kidney, kidney stones, cancer, hypothyroidism or hyperthyroidism, allergies, trauma during the intervention</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: daily 2 g dextrin as 4 capsules of 500 mg</i_keyword>
      <i_keyword>Intervention group: daily 2 g sumac as 4 capsules of 500 mg</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alanine aminotransferase. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Hepatic steatosis. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Using the scanning fiber 502.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total cholestrol. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Low density lipoprotein. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>High density lipoprotein. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Leptin. Timepoint: Before the start of treatment and 12 weeks after intervention. Method of measurement: Elisa.</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>Vice Chancellor for Research of Iran university Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-08</approval_date>
        <contact_name>The ethics committee the University of Medical Sciences Iran</contact_name>
        <contact_address>School of Public Health,Iran University Medical Sciences,The intersection of Sheikh Fazllolallah and shahid Chamran,Hemmat Highway,Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
