<?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>IRCT20190722044309N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-06</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the analgesic effect of coccidiary essential oil and lubricant gel in patients referred for colonoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the analgesic effect of coccidiary essential oil and lubricant gel in patients referred for colonoscopy; Randomized double-blinded clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41117</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: The random allocation method in this study will be the permutation block randomization method, in which "A" represents the intervention group receiving one (no lidocaine), and "B" represents the second group receiving lidocaine 2%. Slow. And "c" represents the third group with a low concentration of cocoa and "D" represents the group receiving the high concentration of the drug. This method is based on 9 blocks in 24 permutations, taking into account all possible displacements (ABCD, ACBD, ABDC, BACD, ....) and assigning zero to 24 (according to random number table) to each of these .displacements. , Runs (ABCD code 0, ACBD code 1, CABD code 2, ... up to 24)
Then, using a random number table, 9 random numbers (rows or columns) are selected and the permissions assigned to each number are written. (Arrange the permutations side by side, left and right, respectively) and how to assign 200 people to four groups of A B C D, Blinding description: Using placebo, the patient and the clinician performing the colonoscopy are kept blind to the study group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>CRC:  IBD::Anal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: receiving a low  concentration of cacti essential oil . Intervention 2: Intervention group: receiving a high  concentration of cacti essential oil . Intervention 3: Control group: Lidocaine-free lubricant gel recipient. Intervention 4: Control group: Gel recipient containing 2% lidocaine.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
no

When:
5m

To whom:
all

Conditions:
Article

Where to obtain:
Article

How to obtain:
Article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Moayed Alavian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical sciences</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8248 313120</zip>
        <telephone>+98 21 8248 3131</telephone>
        <email>sm_alavian@alavian-thc.org</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Ghorbani Ranjbary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8248 313122</zip>
        <telephone>+98 21 8248 3131</telephone>
        <email>ali.ghorbaniranjbary@mail.um.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Experimental groups: A total of 200 individuals were assigned in 4 groups to determine the colonoscopy (Sample sample size with Cochran formula) (each group of 50 was unrelated). Group 2 received a non-lidocaine-type lubricant gel receptor group Lidocaine contains 2% throat, group 3 and 4, receptor of glycolate reductant containing low and high Ziziphora tenuior.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon, unspecified</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: receiving a low  concentration of cacti essential oil .</i_keyword>
      <i_keyword>Intervention group: receiving a high  concentration of cacti essential oil .</i_keyword>
      <i_keyword>Control group: Lidocaine-free lubricant gel recipient</i_keyword>
      <i_keyword>Control group: Gel recipient containing 2% lidocaine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain during a colonoscopy. Timepoint: 1. 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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-16</approval_date>
        <contact_name>Baghiyyatollah al-Azam Military Hospital</contact_name>
        <contact_address>The Baghiyyatollah al-Azam Military Hospital is a military hospital in Mulla Sadra Street in Vanak, Tehran, Iran. The hospital has ties with the Baqiyatallah University of Medical Sciences. TEHRAN Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
