<?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>IRCT2017073135415N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-17</date_registration>
      <primary_sponsor>Vice chancellor for research, Qom  University of Medical Sciences</primary_sponsor>
      <public_title>Assesment of "Dawa al-Blaghm" on liver enzymes in patients with fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Dva’-Albalgham ,on serum levels of liver enzymes in patients with NAFLD.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26767</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: By using the available sampling method, individuals with entry and failure criteria will be included in the study, then treatments will be assigned based on random blocks of four. The blocks and its size and code of cure will be provided by a counselor to a person other than the medical, who measures the response of the patients. Blocks will be randomly selected. According to the estimated number of samples, 25 blocks of volume 4 will be used to select random blocks of dice throwing or Proc PLAN in SAS 9.2 software. Which is based on the treatments provided.&#13;
In this way, the choice of treatment type, block selection and sequence of individuals in each block will also be random.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatty liver desease.</hc_freetext>
      <i_freetext>Intervention 1: The case  group receives Dava Al-balgham tablets two pills with each meal, for three months. Intervention 2: The control group receives cellulose tablets in two tablets each serving for three 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>Hossein Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Iranian Medicine, Third Floor,  Faculty of Dentistry,Saheli St. Qom.Iran.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3770 7843</telephone>
        <email>moradi.medicine@yahoo.com</email>
        <affiliation>Faculty of Traditional Iranian Medicine Qom</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Iranian Medicine, Third Floor,  Faculty of Dentistry,Saheli St. Qom.Iran.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3770 7843</telephone>
        <email>moradi.medicine@yahoo.com</email>
        <affiliation>Faculty of Medicine, Qom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- Non-Alcohol-Fatty Liver Detection (NAFLD-Based Ultrasonography) 2- Serum Liver Enzyme Levels above Normal  3- Age between 18 and 65 years. 4- Fill in the consent form for participation in the plan.&#13;
Exclusion criteria: 1. Patient's lack of consent to continue participating in the project. 2. Any allergy to the drug. 3. The occurrence of any new liver disease that requires the use of specific liver medicines. 4. Pregnancy.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>64 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>Nonalcoholic fatty liver disease (NAFLD)</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>The case  group receives Dava Al-balgham tablets two pills with each meal, for three months.</i_keyword>
      <i_keyword>The control group receives cellulose tablets in two tablets each serving for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ast. Timepoint: On arrival, three months after taking a medication or placebo. Method of measurement: U / L, Spectrophotometer.</prim_outcome>
      <prim_outcome>Alt. Timepoint: On arrival, three months after taking a medication or placebo. Method of measurement: U / L, Spectrophotometer.</prim_outcome>
      <prim_outcome>Alkp. Timepoint: On arrival, three months after taking a medication or placebo. Method of measurement: U / L, Spectrophotometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Crt. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: U / L, Spectrophotometer.</sec_outcome>
      <sec_outcome>BUN. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: U / L, Spectrophotometer.</sec_outcome>
      <sec_outcome>PT. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: U / L, Spectrophotometer.</sec_outcome>
      <sec_outcome>PTT. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: U / L, Spectrophotometer.</sec_outcome>
      <sec_outcome>INR. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: U / L, Spectrophotometer.</sec_outcome>
      <sec_outcome>Level of quality of life. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: Questionnaire 36 questions.</sec_outcome>
      <sec_outcome>BMI. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: Weight/(height(meter))2 Kg/m2.</sec_outcome>
      <sec_outcome>WHR. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: Waist to hip circumference Cm/cm.</sec_outcome>
      <sec_outcome>Blood presure. Timepoint: At the beginning of the intervention, three months after taking the medication or placebo. Method of measurement: Mercury pressure meter mmHg.</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, Qom  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-04</approval_date>
        <contact_name>Ethics committee of Qom  University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Saheli street, Qom, Iran Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
