<?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>IRCT20160920029889N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-07</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Colchicine on aphthous ulceration.</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the clinical efficacy of Colchicine-loaded polymeric nanofibers on aphthous ulceration, A Pilot Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66858</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, eligible patients will be selected non-randomized, sequential. Then these patients are coded using computer random allocation software, and then the codes are divided into two parts, and each part of the codes will be assigned to a group.</study_design>
      <phase>2</phase>
      <hc_freetext>Aphthous.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A circular piece of polymer nanofibers with a diameter of 1.2 cm containing 1 mg of colchicine is prescribed to each patient and he will be taught to place the piece directly on the aphthous lesion without drying the mucous membrane of the wound. then it will be emphasized that the mouth should be open for two minutes and after connecting the nanofiber mat to the relevant surface, refrain from moving it with the help of the tongue so that the medicine is released slowly. This procedure is performed 3 times a day. The patient will be taught that if the mucous surface is dry before using the medicine, after placing the mat on the lesion, ensure that the mat is moistened. In addition, the medicine should be used after eating and avoid eating and drinking for an hour after that. Intervention 2: Control group: each patient will be given a package and will be taught to first dry the mucous surface of the wound slowly and then soak a small piece of sanitary cotton measuring about 3 x 3 centimeters with medicine and place it on the infected lesion. Then it will be emphasized that the mouth should be open for two minutes and perform this action 3 times a day. The patient will be taught to use the medicine after eating and to avoid eating and drinking for an hour after.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Morad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Sajjad (AS) Hospital, Enghelab square, Shahid Motahari Ave.</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۶۹۱۷۱۴۱۴۱</zip>
        <telephone>+98 11 5522 5151</telephone>
        <email>h.morad@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Shiva</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Faculty of Pharmacy, Pardis Nazlou, 11 km of Nazlou Road, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3275 4991</telephone>
        <email>shiva@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range between 20 and 40 years
No more than a day has passed since the beginning of aphthous ulcers
Not using another treatment method for your aphthous lesions before visiting
No history of known systemic disease associated with aphthous ulcers
Not having suspicious symptoms of systemic diseases related to aphthous ulcers</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recent use of colchicine
Using another drug simultaneously with the drugs prescribed to treat the pest
Not to use the medicine as recommended according to the patient's own statements
Failure to return the patient for re-examination
The presence of lesions in the area of ​​the tonsils and the posterior 1/3 of the mouth
Concomitant use of immunosuppressive drugs
Lactating and pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Recurrent oral aphthae</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: A circular piece of polymer nanofibers with a diameter of 1.2 cm containing 1 mg of colchicine is prescribed to each patient and he will be taught to place the piece directly on the aphthous lesion without drying the mucous membrane of the wound. then it will be emphasized that the mouth should be open for two minutes and after connecting the nanofiber mat to the relevant surface, refrain from moving it with the help of the tongue so that the medicine is released slowly. This procedure is performed 3 times a day. The patient will be taught that if the mucous surface is dry before using the medicine, after placing the mat on the lesion, ensure that the mat is moistened. In addition, the medicine should be used after eating and avoid eating and drinking for an hour after that.</i_keyword>
      <i_keyword>Control group: each patient will be given a package and will be taught to first dry the mucous surface of the wound slowly and then soak a small piece of sanitary cotton measuring about 3 x 3 centimeters with medicine and place it on the infected lesion. Then it will be emphasized that the mouth should be open for two minutes and perform this action 3 times a day. The patient will be taught to use the medicine after eating and to avoid eating and drinking for an hour after.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: Before and 7 days after the start of treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Size of the lesion. Timepoint: Before and 7 days after the start of treatment. Method of measurement: Graph paper.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-18</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Valie-Asr Boulevard Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
