<?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>IRCT20170730035381N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-28</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Extra Virgin Olive Oil and Canola Oil in Treatment of Patients with Ulcerative Colitis(UC)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Extra Virgin Olive Oil and Canola Oil on Clinical Outcomes and Inflammatory Markers (hsCRP, TNF-α) among Patients with Ulcerative Colitis(UC)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26750</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization in this study will be done by block method, which means that the researcher divides individuals into subgroups called blocks. The randomization unit in this study is a block and the number of people in each block is similar and four. Assignment of patients to each groups of the treatment will be done by using these blocks. In this method, SAS algorithm software is used to make random sequences and determine the type of treatment assigned to each patient.
Concealment will also be done by placing the type of treatment assigned to each person in the envelope, so that the person providing the treatment is unaware, Blinding description: The type of blindness in our study will be single-blind, so that the person who evaluate the outcomes of the study (data analyzer), does not know the type of treatment assigned to each patient. The type of treatment and its order is characterized by coding. In this study, due to the nature of complementary treatment (Extra Virgin Olive oil and Canola Oil), there is no possibility for blinding participant, clinician and researcher.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ulcerative colitis.</hc_freetext>
      <i_freetext>Intervention 1: Extra virgin olive oil; 50 ml once daily; Crossover intervention for 20 days and 14 days wash out; with food in raw form (no frying and cooking oil); Aryan Tame Khazar Co. Intervention 2: Intervention group: Canola oil; 50 ml once daily; Crossover intervention for 20 days and 14 days wash out; with food in raw form (no frying and cooking oil); Aryan Tame Khazar Co.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnaz Morvaridi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinical Research Centers, Imam Khomeini Hospital, Azadegan Ave., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61936-73166</zip>
        <telephone>+98 61 3221 6104</telephone>
        <email>morvaridi.m@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Jafarirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedical School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3336 7543</telephone>
        <email>jafarirad-s@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ulcerative colitis, confirmed by histopathology
The severity of the disease is mild to moderate
Non-infectious, autoimmune and inclusive diseases (including cancer, kidney disease, rheumatoid arthritis, liver, AIDS, and cardiovascular disease)
No use of ω3 supplements, fish oil
Body mass index ranges from 18.5 to 30
The patient should not be pregnant or breastfeeding
The age range is between 18 and 75 years old
People's Inclination to collaborate on the plan</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient is in the acute phase of the disease
The patient does not tolerate the recommended oils
reluctancy to continue cooperation in this research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Extra virgin olive oil; 50 ml once daily; Crossover intervention for 20 days and 14 days wash out; with food in raw form (no frying and cooking oil); Aryan Tame Khazar Co.</i_keyword>
      <i_keyword>Intervention group: Canola oil; 50 ml once daily; Crossover intervention for 20 days and 14 days wash out; with food in raw form (no frying and cooking oil); Aryan Tame Khazar Co.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum hs-CRP. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum TNF-α. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum ESR. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Stool frequency per day. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: Mayo score.</prim_outcome>
      <prim_outcome>Frequency of rectal bleeding per day. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: Mayo score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: Scales.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: BMI by formula.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: Non stretch meter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: The beginning of the study - the end of the twentieth day. Method of measurement: Non stretch meter.</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 and Technology of Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-25</approval_date>
        <contact_name>•Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ethics committee in research, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
