<?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>IRCT2014101619554N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-02</date_registration>
      <primary_sponsor>Vice Chancellor for Research,Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Chlorella Volgaris versus Arthichoke on patients with NAFLD- A randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Chlorella Volgaris versus Arthichoke on patients with NAFLD- A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17473</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention:30 patient as the control group only received treatment with metformin and vitamin E, The second group,30 patients were treated with Chlorella supplements and third group (30 patients),were treated with Arthichoke supplements.Patients are recommended to have daily 20 minutes of physical activity and diet 500 kcal less than the previous in a group that have BMI 30-35 and 300 kcal in BMI 25-30 as well as. Main outcom:After eight weeks of treatment is measured serum levels of liver enzymes (ALT) and its level is considered as a measure of treatment response. (Reduced serum levels of at least 3 times as the response to treatment). Intervention 2: In the control group, 30 patients receiving metformin 500 mg( is made of Eksir company) 2 times a day, after breakfast and dinner,also vitamin E 400 IU ( is made of Eksir company)once a day after lunch.Nutrition and exercise advice given to patients for 2 months.</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>Vice Chancellor for Research,Zanjan University of Medical Sciences,.Dr Faghihzade Soghrat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Metabolic Research Center,vali Asr Hospital, Highway Sheikh Fadlallah Noori,Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3377 0805</telephone>
        <email>Dr.shirinjameshorani@yahoo.com ; Dr.shirinjameshorani@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences,</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Jameshorani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Metabolic Research Center,vali Asr Hospital, Highway Sheikh Fadlallah Noori,Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3377 0805</telephone>
        <email>dr.shirinjameshorani@yahoo</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Inclusion criteria:&#13;
  Proven fatty liver by Ultrasound, Increase liver enzyme alanine aminotransferase (ALT) between 1.5 to 5 times the normal; The mean BMI between 25-35&#13;
 Exclusion criteria:&#13;
  Patients with nonalcoholic steatohepatitis; Patients with systemic diseases such as diabetes - and other inflammatory diseases; Positive serology for hepatitis viral, anti-mitochondrial antibody (AMA); positive anti- nuclear antibody (ANA); TIBC increased serum iron and transferrin,TIBC,  positive serum ceruloplasmin; Other secondary causes of fatty liver,  Transferrin saturation more than 45.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K75.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>nonalcoholic steatohepatitis</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>Intervention:30 patient as the control group only received treatment with metformin and vitamin E, The second group,30 patients were treated with Chlorella supplements and third group (30 patients),were treated with Arthichoke supplements.Patients are recommended to have daily 20 minutes of physical activity and diet 500 kcal less than the previous in a group that have BMI 30-35 and 300 kcal in BMI 25-30 as well as. Main outcom:After eight weeks of treatment is measured serum levels of liver enzymes (ALT) and its level is considered as a measure of treatment response. (Reduced serum levels of at least 3 times as the response to treatment).</i_keyword>
      <i_keyword>In the control group, 30 patients receiving metformin 500 mg( is made of Eksir company) 2 times a day, after breakfast and dinner,also vitamin E 400 IU ( is made of Eksir company)once a day after lunch.Nutrition and exercise advice given to patients for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver Function Test. Timepoint: 2m after intervention. Method of measurement: Eliza method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>BMI(Body Mass Index). Timepoint: 2m. Method of measurement: kg/m2.</sec_outcome>
      <sec_outcome>Blood Presser. Timepoint: 2m. Method of measurement: Digital manometer.</sec_outcome>
      <sec_outcome>Lipid Profil. Timepoint: 2month. Method of measurement: Eliza.</sec_outcome>
      <sec_outcome>Blood sugar. Timepoint: 2month. Method of measurement: Eliza.</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_id>
        <sec_id>-</sec_id>
        <issuing_authority>-</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for Research,Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-09-23</approval_date>
        <contact_name>Ethics Committee Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences,Republic Street, Freedom Boulevard , opposit of Saderat Bank, Zanjan University of Medical Sciences Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
