<?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>IRCT20230903059334N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-16</date_registration>
      <primary_sponsor>Khalkhal university of medical science</primary_sponsor>
      <public_title>Effect of rosa canina on non alcoholic fatty liver disaese</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rosa canina supplement on liver enzymes, lipid profile, fasting blood glucose and anthropometric  indices in patients with non-alcoholic fatty liver disease under weight loss diet</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72390</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling by randomization method with RAS software and allocation of 3-digit codes with sealed envelopes will be done by a person outside the study, then people will be allocated to two groups by block randomization based on age, Blinding description: The principal investigator of this study and the study participants are kept blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non alchoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will be given a weight loss diet and 1 gram of rosa canina 2 times a day in the form of 500 mg capsules with a glass of water in the morning and evening snacks for 8 weeks. It was disinfected and packaged in Ardabil University of Medical Sciences. Intervention 2: Control group: The control group will be given a weight loss diet and 1 gram of placebo twice a day in the form of a 500 mg capsule with a glass of water in the morning and evening meals for 8 weeks; It should be noted that this placebo will look exactly the same as the rosa canina capsule. Starch powder will be used for placebo capsules. Placebo capsules will be prepared by the Faculty of Pharmacy of Ardabil University of Medical Sciences.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahideh Aghamohammadi khiavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalkhal university of medical science , Mozaffar Azizi st , Imam blv</address>
        <city>Khalkhal</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۶۸۱۷۶۱۳۵۱</zip>
        <telephone>32426801</telephone>
        <email>v_agamohammadi@yahoo.com</email>
        <affiliation>Khalkhal university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahideh Aghamohammadi khiavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalkhal university of medical science , Mozaffar Azizi st , Imam blv</address>
        <city>Khalkhal</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۶۸۱۷۶۱۳۵۱</zip>
        <telephone>+98 45 3243 2002</telephone>
        <email>v_agamohammadi@yahoo.com</email>
        <affiliation>Khalkhal university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All people with non-alcoholic fatty liver disease referring to Internist</inclusion_criteria>
      <agemin>18 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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will be given a weight loss diet and 1 gram of rosa canina 2 times a day in the form of 500 mg capsules with a glass of water in the morning and evening snacks for 8 weeks. It was disinfected and packaged in Ardabil University of Medical Sciences.</i_keyword>
      <i_keyword>Control group: The control group will be given a weight loss diet and 1 gram of placebo twice a day in the form of a 500 mg capsule with a glass of water in the morning and evening meals for 8 weeks; It should be noted that this placebo will look exactly the same as the rosa canina capsule. Starch powder will be used for placebo capsules. Placebo capsules will be prepared by the Faculty of Pharmacy of Ardabil University of Medical Sciences.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver enzymes. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Pars azmoon liver enzymes kit.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Pars Azmoun Cholesterol Quantification Kit.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Glucose Quantification Kit Pars Azman.</prim_outcome>
      <prim_outcome>Body weight. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Seca scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Barometer.</sec_outcome>
      <sec_outcome>Waist circulate. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Measuring tape.</sec_outcome>
      <sec_outcome>Body fat mass. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Inbody body analyzer.</sec_outcome>
      <sec_outcome>Body muscle mass. Timepoint: At the beginning of the study and 8 weeks after the start of taking rosa canina supplement. Method of measurement: Inbody body analyzer.</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>Khalkhal university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-05</approval_date>
        <contact_name>Ethics committee of Khalkhal university of medical science</contact_name>
        <contact_address>Khalkhal university of medical science, Mozaffar Azizi st , imam blv Khalkhal Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
