<?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>IRCT20190309042987N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-19</date_registration>
      <primary_sponsor>Vice-Chancellor For Research Of Azad University</primary_sponsor>
      <public_title>The effect of a training program of non-alcoholic fatty liver</public_title>
      <acronym>کبد چرب غیرالکلی</acronym>
      <scientific_title>The effect of a training program on biochemical markers of non-alcoholic fatty liver</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38178</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method was based on the homogeneity of the ultrasound results or the elevated liver enzyme test, so that each of the four people who had the highest fatty liver or the highest enzyme level were placed in one of the four groups in random order. And so are the next 4 and so on, Blinding description: The supplement + exercise group and supplement group receive 2 capsules of 500 mg periphenol capsules per day (manufactured by Pars Health Company and approved by the Institute of Medicinal Plants, Jihad University) and the placebo + + daily exercise will receive 2 placebo capsules (pills containing wheat flour). (Table 3). The control group did not attend any sports program and did not receive any nutritional or supplementary advice.
The contents of periphon capsules and nutrient content per 100 grams of purpureum and dietary percentages are listed in Table 4 and 5.
To ensure promise, capsules are distributed on a weekly basis, along with the necessary advice (for the amount and timing) of the participants. Both groups will be trained to take capsules every two days after breakfast and dinner. To do this, the capsules were packed in similar packages with the same information and instructions and coded by an individual other than the intervener in the form A, B so that the interceptor did not know the type of capsule received by each Observe the group. Follow-up of supplementation by the subjects is contacted daily by telephone, and the claimed amounts are followed up and information is received. Patients who have not taken their pills are excluded from the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>non-alcholic fatty liver desease.</hc_freetext>
      <i_freetext>Intervention 1: Supplementary group group: 500 Gram pillow after breakfast and dinner for 3 months. Intervention 2: Placebo group: Two daily pills containing wheat flour for 3 months. Intervention 3: Exercise group: Aerobic and resistance training for 3 months. Intervention 4: Exercise + exercise group: 3 months of aerobic-resilient activity plus supplements.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I will decide in consultation with the supervisor</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Aliniya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rostamian Street, 17th Alley</address>
        <city>AStara</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4391655314</zip>
        <telephone>+98 13 4483 6878</telephone>
        <email>Aliniya.n@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Aliniya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rostamian Street, 17th Alley</address>
        <city>AStara</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4391655314</zip>
        <telephone>+98 13 4483 6878</telephone>
        <email>Aliniya.n@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women 40-60 years old
Having a non-alcoholic fatty liver with varying degrees
Not having any illness other than fatty liver
Being a menopause</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having heart-respiratory disease, kidney, hypertension
Acute diseases such as viral hepatitis and other non-alcoholic liver diseases other than non-alcoholic fatty liver (such as viral hepatitis B, C, autoimmune hepatitis, celiac disease, Wilson, a 1-antithyrium deficiency and hemochromatosis)
Alcohol and tobacco use
Having regular exercise in the last 6 months,
Coagulation disorders,
Impairment of the immune system,
Pulmonary problems, hypothyroidism
Damage to the limb that prevents exercise.
Having any surgery,
Slight and waning weight loss
Chronic or acute liver disorders, cancer, liver transplantation,
Pregnancy, breastfeeding,
Use of any supplement and medicinal herbs</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>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Supplementary group group: 500 Gram pillow after breakfast and dinner for 3 months</i_keyword>
      <i_keyword>Placebo group: Two daily pills containing wheat flour for 3 months</i_keyword>
      <i_keyword>Exercise group: Aerobic and resistance training for 3 months</i_keyword>
      <i_keyword>Exercise + exercise group: 3 months of aerobic-resilient activity plus supplements</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cholesterol. Timepoint: Start and end of study. Method of measurement: Radiocommunication.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Start and end of study. Method of measurement: Radiocommunication.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Start and end of study. Method of measurement: Radiocommunication.</prim_outcome>
      <prim_outcome>AST. Timepoint: Start and end of study. Method of measurement: Enzymatic method using kit.</prim_outcome>
      <prim_outcome>ALT. Timepoint: Start and end of study. Method of measurement: Enzymatic method using kit.</prim_outcome>
      <prim_outcome>ALP. Timepoint: Start and end of study. Method of measurement: Enzymatic method using kit.</prim_outcome>
      <prim_outcome>Degree of fatty liver. Timepoint: Start and end of study. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body mass index. Timepoint: Start and end of study. Method of measurement: Using scales and centimeters.</sec_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: Start and end of study. Method of measurement: Using centimeters.</sec_outcome>
      <sec_outcome>Body fat percentage. Timepoint: Start and end of study. Method of measurement: Caliper.</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 Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-05</approval_date>
        <contact_name>Ethics Committee on Biomedical Research of Islamic Azad University, Rasht Branch</contact_name>
        <contact_address>Golkesh-Golestan Bridge Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
