<?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>IRCT20210719051943N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-22</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>adding erythromycin and metoclopramide to the  diet of colonoscopy preparation</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of adding erythromycin and metoclopramide to the standard diet of colonoscopy in colonoscopy preparation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>350</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58094</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A stochastic sequence will be generated by the block analytics method using a limited block randomization method. Random allocation encryption will be performed by the analyzer itself using the method of using opaque sealed 
envelopes sealed with random sequence (SNOSE). Participants will attend the study over time and on a random. interventionism  and control groups  will  be assigned  based on accident (coin toss).</study_design>
      <phase>2</phase>
      <hc_freetext>Colonoscopic preparation.</hc_freetext>
      <i_freetext>Intervention 1: Control group: High volume peg 4 liters. Intervention 2: Intervention group1: Peg high volume + 3  tablets 10 mg metoclopramide. Intervention 3: Intervention group 2: Peg high volume +3 mg tablets 400 erythromycin+ 3  tablets 10 mg metoclopramide. Intervention 4: Intervention group3: Peg high volume +3  tablets 20 metoclopramide + 3 erythromycin 400 mg tablets. Intervention 5: Intervention group 4:  Peg low volume + 2 mg 20 metoclopramide tablets.</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 The results of the study should be reviewed.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Pezeshki modares</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti BLV</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719964797</zip>
        <telephone>+98 25 3612 2000</telephone>
        <email>mpezeshkim@muq.ac.ir</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Pezeshki modares</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti BLV</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719964797</zip>
        <telephone>+98 25 3612 2000</telephone>
        <email>mpezeshkim@muq.ac.ir</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18 years and older
Outpatients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Intestinal inflammation
Cardiopulmonary diseases
severe nausea
patients with decreased consciousness
Patients with a history of drug allergy
Intestinal perforation
Intestinal obstruction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: High volume peg 4 liters</i_keyword>
      <i_keyword>Intervention group1: Peg high volume + 3  tablets 10 mg metoclopramide</i_keyword>
      <i_keyword>Intervention group 2: Peg high volume +3 mg tablets 400 erythromycin+ 3  tablets 10 mg metoclopramide</i_keyword>
      <i_keyword>Intervention group3: Peg high volume +3  tablets 20 metoclopramide + 3 erythromycin 400 mg tablets</i_keyword>
      <i_keyword>Intervention group 4:  Peg low volume + 2 mg 20 metoclopramide tablets</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining colon preparation  quality. Timepoint: All colonoscopies will be performed in the period from 9 am to 1 pm by a gastroenterologist (to standardize the examination method). This may take between 15 and 30 minutes per person. clinical outcome assessed with colonoscopist during the procedure. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Cecum intubation mean time. Timepoint: All colonoscopies will be performed in the period from 9 am to 1 pm by a gastroenterologist (to standardize the examination method). This may take between 15 and 30 minutes per person. clinical outcome assessed with colonoscopist during the procedure. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Polyp detection frequency. Timepoint: All colonoscopies will be performed in the period from 9 am to 1 pm by a gastroenterologist (to standardize the examination method). This may take between 15 and 30 minutes per person. clinical outcome assessed with colonoscopist during the procedure. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-02</approval_date>
        <contact_name>Ethics committee of qom University of Medical Sciences</contact_name>
        <contact_address>Beheshti Blv Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
