<?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>IRCT20130521013406N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-07</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Phenytoin Mucoadehesive Tablet versus Mouthwash in treatment of Oral Mucositis</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Phenytoin mucoadhesive tablet versus mouthwash on chemotherapy induced oral mucositis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40243</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomized study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>chemotherapy induced oral  mucositis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: phenytoin mucoadhesive tablet                    Mucoadhesive tablets are prepared by direct compression method. The ingredients (10 mg sodium phenytoin and the remaining ingredient was HPMC: Chitosan; NaCMC, 25:25:50 w/w %) are weighed accurately and mixed by trituration in a mortar by pestle for 15 minutes. Then all of the ingredients are passed through sieve no. 100. Finally the mixture is compressed to tablet using Korsch single punch compression machine (ERWEKA, German).Each day, two tablets should be attached inside the cheek until they are dissolved and the treatment should be continued until the complete healing of oral lesions or for a maximum of two weeks. Intervention 2: Intervention group: Phenytoin mouthwash                                   Appropriate amount of sodium phenytoin is dissolved in 1 L of distilled water which contain 0.1% Tween 80 and Disodium hydrogen phosphate (2.38 g/L), with adjusted pH on 7.0±0.02 using phosphoric acid. The final concentration of phenytoin mouthwash is 0.333 mg/mL. patients are instructed to rinse (gargle) 10 ml of the solution for one minute, three times a day (to distribute evenly to all parts of the oral tissues), and then spit (to minimize the systemic absorption). They are told to avoid eating during the first hour after treatment.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Rezazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences, Zand Ave, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>Rezazadehf@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Rezazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical sciences, Zand Ave, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>rezazadehf@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients underwent chemotherapy process, due to various types of malignancies, without concurrent radiotherapy
mucositis grade 2 or 3 (WHO criteria)
prognosis for at least 6 months
signing the consent form</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with mucositis of grade 1 or 4
sign of causing side effects (such as sensitivity to phenytoin)
lack of patient cooperation or trend to complete the treatment process
systemic diseases with oral mucositis (such as connective tissue diseases and Sjogren syndrome)or interfering with healing process of tissues (such as diabetes)
smoking and alcohol consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oral mucositis (ulcerative) due to antineoplastic therapy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: phenytoin mucoadhesive tablet                    Mucoadhesive tablets are prepared by direct compression method. The ingredients (10 mg sodium phenytoin and the remaining ingredient was HPMC: Chitosan; NaCMC, 25:25:50 w/w %) are weighed accurately and mixed by trituration in a mortar by pestle for 15 minutes. Then all of the ingredients are passed through sieve no. 100. Finally the mixture is compressed to tablet using Korsch single punch compression machine (ERWEKA, German).Each day, two tablets should be attached inside the cheek until they are dissolved and the treatment should be continued until the complete healing of oral lesions or for a maximum of two weeks.</i_keyword>
      <i_keyword>Intervention group: Phenytoin mouthwash                                   Appropriate amount of sodium phenytoin is dissolved in 1 L of distilled water which contain 0.1% Tween 80 and Disodium hydrogen phosphate (2.38 g/L), with adjusted pH on 7.0±0.02 using phosphoric acid. The final concentration of phenytoin mouthwash is 0.333 mg/mL. patients are instructed to rinse (gargle) 10 ml of the solution for one minute, three times a day (to distribute evenly to all parts of the oral tissues), and then spit (to minimize the systemic absorption). They are told to avoid eating during the first hour after treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Grade of oral mucositis and pain. Timepoint: before intervention, 1 and 2 weeks after intervention. Method of measurement: WHO grading and 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-09</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
