<?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>IRCT2013122415864N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-06</date_registration>
      <primary_sponsor>School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe</primary_sponsor>
      <public_title>Effect of  diet based on the principles of traditional medicine in cirrhosis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of a diet based on the principles of traditional medicine on the clinical symptoms and Para clinical in the Class A and B patients with cirrhosis admitted to Imam Hussein and Taleghani hospital in 92-93 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15001</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>cirrhosis of liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: diet for breakfast, lunch, dinner, based on the principles of Traditional Medicine with commands to protect the health based on the principles of Traditional Medicine in the regulation of the habits of sleep and food. Intervention 2: Control group: daily diet with commands to protect the health based on the principles of Traditional Medicine in the regulation of the habits of sleep and food.</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>Rasool Choopani M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8 Shams Alley, opposite Tavanir St., Vali Asr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>sitm@sbmu.ac.ir; rchoopani@sbmu.ac.ir; http://traditional.sbmu.ac.ir</email>
        <affiliation>School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Javad Ehsani Ardekani M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen St., Shahid Chamran Highway, Taleghani Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 23871</telephone>
        <email>MJehsani@yahoo.com</email>
        <affiliation>Department of Gastroenterology and Hepatology, Taleghani Hospital, Shahid Beheshti University of Med</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Class A and B cirrhosis diagnosed by ultrasonography; Age 20-70; Informed consent; Lack of complications of acute illness within 2 weeks; Not get out of the routine treatment protocols over the past 2 weeks; Non- hepato cellular carcinoma; Lack of hepatic encephalopathy; Lack of chronic renal failure; Non- diabetic.&#13;
Exclusion criteria were: Failure to follow instructions for two weeks; Complications leading to hospitalization; Intolerance Diet Plan whatever reason.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K74.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified cirrhosis of liver</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: diet for breakfast, lunch, dinner, based on the principles of Traditional Medicine with commands to protect the health based on the principles of Traditional Medicine in the regulation of the habits of sleep and food</i_keyword>
      <i_keyword>Control group: daily diet with commands to protect the health based on the principles of Traditional Medicine in the regulation of the habits of sleep and food</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Mass Index. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Balance &amp; Meter.</prim_outcome>
      <prim_outcome>Muscle spasm. Timepoint: Weeks 4, 8 &amp;12 from start of intervention. Method of measurement: Question from patient.</prim_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: Weeks 4, 8 &amp;12 from start of intervention. Method of measurement: Question from patient.</prim_outcome>
      <prim_outcome>Serum Albumin. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Electrophoresis.</prim_outcome>
      <prim_outcome>Bilirubin Total. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>International normalized ratio. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Alanine transaminase. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Alkaline phosphatase. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Serum Creatinine. Timepoint: Before intervention &amp; week 12 after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe</source_name>
      <source_name>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-29</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences, Office of Research Affairs, Depu</contact_name>
        <contact_address>Parvaneh St., Yemen St., Shahid Chamran Highway, next to Taleghani Hospital, Sixth Floor, College Staff Building Number Two, Shahid Beheshti University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
