<?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>IRCT20201204049599N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-15</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of promethazine prescription on improving endoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the promethazine prescription effect on sedation, nausea reduction and quality of the upper Esophageal gastro Endoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55271</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention or control groups by the randomization method with a table of random numbers. First, patients will be given a code from 01 to 22. Then a number will be randomly selected from the table and will be continued from top to bottom in the table to complete the sample size. The duplicate number will be ignored and another number from the table will be checked. Numbers 01 to 11 and 11 to 22 will be assigned to the intervention group and control group, respectively, Blinding description: The study will be double-blind. The patient and the endoscopist will be blind that which groups each patient belongs to. The amount, color, and even taste of promethazine and glucose syrup will be given equally to patients in both groups. In the intervention group, 30 cc of promethazine syrup is added into 70 cc of drinking water, one hour before the endoscopy will be given to the patient by someone other than the endoscopist. In the control group, 50 g of sugar is dissolved in 100 cc of drinking water. It will be given to the patients one hour before endoscopy after adding five cc of cherry juice (to match the color and taste of promethazine syrup).</study_design>
      <phase>3</phase>
      <hc_freetext>Upper gastrointestinal endoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 30 cc of promethazine syrup in 100 cc of drinking water made by Emad Darman Pars Pharmaceutical Company (1mg /1cc ) will be given to the patient one hour before endoscopy by someone other than the endoscopist. Intervention 2: Control group: Patients will be given a solution of 50 g of glucose in 100 cc of drinking water half an hour before the upper gastrointestinal endoscopy.</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 more information provided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Pashaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital; Ershad boulevard</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3198 8001</telephone>
        <email>pashaee.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Pashaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital; Ershad boulevard</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3198 8001</telephone>
        <email>pashaee.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 40 years
Systolic blood pressure greater than 90 and less than 130 mm Hg
Peripheral blood oxygen saturation with pulse oximetry is more than 95%
Respiratory rate between 12 and 18 times per minute
Do not take certain medications for a long time other than antacids.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnancy
Presence of diabetes, hypertension, thyroid disease, heart disease, liver disease such as cirrhosis and hepatitis, chronic or acute lung disease, Rheumatologic disease, neurological disease</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, 30 cc of promethazine syrup in 100 cc of drinking water made by Emad Darman Pars Pharmaceutical Company (1mg /1cc ) will be given to the patient one hour before endoscopy by someone other than the endoscopist.</i_keyword>
      <i_keyword>Control group: Patients will be given a solution of 50 g of glucose in 100 cc of drinking water half an hour before the upper gastrointestinal endoscopy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total procedure time. Timepoint: During endoscopy. Method of measurement: Minute / Stopwatch.</prim_outcome>
      <prim_outcome>Patient cooperation. Timepoint: During endoscopy. Method of measurement: Less than 5 retching, excellent / 6-10 times retching, good / 11-15 times retching, moderate / more than 16 retching, bad.</prim_outcome>
      <prim_outcome>Endoscopist Satisfaction. Timepoint: During endoscopy. Method of measurement: Endoscopist Statement: Easy Completion / Relatively Easy Completion / Difficult Completion / Incomplete.</prim_outcome>
      <prim_outcome>Patient satisfaction. Timepoint: During endoscopy. Method of measurement: Patient statement: very good / good / average / unpleasant.</prim_outcome>
      <prim_outcome>Recovery time. Timepoint: After endoscopy until discharge. Method of measurement: Minute / Stopwatch.</prim_outcome>
      <prim_outcome>Complications. Timepoint: From the time of drug administration until 24 hours later. Method of measurement: Through examination and self-declaration of the patient: yes / no.</prim_outcome>
      <prim_outcome>Patient Anxiety. Timepoint: During endoscopy. Method of measurement: Patient statement in response to the anxiety level question: very high / high / medium / low / very low / not at all.</prim_outcome>
      <prim_outcome>Patient level of consciousness. Timepoint: During endoscopy. Method of measurement: Assess the patient's level of consciousness based on the Glasgow Coma Scale.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-25</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences; Resalat boulevard Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
