<?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>IRCT20181230042172N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-20</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Citrullus colocynthis (L.) Schrad oil and Dentol drop on tooth pain reduction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Citrullus colocynthis (L.) Schrad oil and Dentol drop on tooth pain reduction: Double blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36397</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: ُSimple randomization is done based on Sortition, Blinding description: The outcome evaluator and patients are kept blind. Test samples are coded in similar size and packages by investigator and it is given to the outcome  evaluator, who is unaware of the contents of each package. After obtainig informed consent from the patient and the necessary explanations about the study and their safety and completing the questionnaire. Then clinician will take one of the packages and write the code in questionnaire before starting the test.</study_design>
      <phase>3</phase>
      <hc_freetext>Tooth pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cotton bullet impregnated with 0.2 ml of Citrullus colocynthis (L.) Schrad TOUBA company topically for 10 minutes on a tooth that is painful. Intervention 2: Intervention group: Cotton bullet impregnated with 0.2 ml of ِDentol drop Khorraman company topically for 10 minutes on a tooth that is painful. Intervention 3: Control group: Cotton bullet impregnated with 0.2 ml of sesame oil topically for 10 minutes on a tooth that is painful.</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:
All data is accessible after being unrecognizable

When:
6 months after the results are published

To whom:
All researchers have access to data

Conditions:
There are no special conditions

Where to obtain:
Dental College, Lorestan University of Medical Sciences

How to obtain:
There is no particular process

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Hamzelouei Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi St., Khorram-Abad Dental College</address>
        <city>Khorram-Abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 3320 7826</telephone>
        <email>dr.hamzelouei@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Hamzelouei Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi St., Khorram-Abad Dental College</address>
        <city>Khorram-Abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 3320 7826</telephone>
        <email>dr.hamzelouei@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy clients suffering from tooth pain referring to the dental clinic of Khorramabad dental college, Lorestan University of Medical Sciences in 2019
Those aged 18 to 40 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnants
Patients in ASA ll or more health status
Patients have taken analgesics and antibiotics in 12 hours before the test
Fail in cooperation
Those who have a history of allergy to Citrullus colocynthis (L.) Schrad
Those who use drug and alcohol
Those who have a disorder of the immune system</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of pulp and periapical tissues-Pulpitis-irreversible</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cotton bullet impregnated with 0.2 ml of Citrullus colocynthis (L.) Schrad TOUBA company topically for 10 minutes on a tooth that is painful</i_keyword>
      <i_keyword>Intervention group: Cotton bullet impregnated with 0.2 ml of ِDentol drop Khorraman company topically for 10 minutes on a tooth that is painful.</i_keyword>
      <i_keyword>Control group: Cotton bullet impregnated with 0.2 ml of sesame oil topically for 10 minutes on a tooth that is painful.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score pain severity on  the Visual Analogue Scale. Timepoint: Before the intervention and 10 minutes after the intervention. Method of measurement: Visual Analogue 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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-31</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, Lorestan University of Medical Sciences, Academic Complex Kamalvand Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
