<?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>IRCT20100101002950N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-17</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the efficacy of oral curcumin on complex aphthous</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of oral curcumin on recurrency and number of complex aphthous lesions in the patients referred to the Oral and maxillofacial medicine Department of Guilan Dental School in 2021-2022</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57070</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Oral complex aphthous.</hc_freetext>
      <i_freetext>Intervention group:Consumption of 2 oral sina Curcumin capsule 40 mg once a day for 1 month.</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:
Data will shareable after making them unidentifiable

When:
Accessibility will starts from 6 month after publish

To whom:
Data will be available to researchers working in academic and scientific institutions.

Conditions:
They can use them with refrence

Where to obtain:
Dr.seyed javad kia
djavadkia@yahoo.com

How to obtain:
After receiving the request, the documents will be delivered to the applicant within one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Seyed Javad Kia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan dental school, Fuman-Saravan Rd</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41941-73774</zip>
        <telephone>009813336416</telephone>
        <email>DJavadkia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Javad Kia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan dental school, Fuman-Saravan Rd</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41941-73774</zip>
        <telephone>+98 13 3348 6416</telephone>
        <email>DJavadkia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between the ages of 20 and 60 years
Complex aphthous ulcers, which include: a number of painful aphthous lesions on the oral mucosa that appear intermittently and heal slowly; 
Created in less than 72 hours</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients taking topical medication to treat the aphthous in the last two weeks or taking systemic medication in the last one month
Patients with systemic diseases such as intestinal and gastric diseases (Crohn's and ulcerative colitis), Behcet's disease, Reiter's syndrome and gallstones
Patients with anxiety disorders
Patients with bracets
Pregnant and lactating women
Patients with a history of alcohol and drug use
Patients treated with immunosuppressants, chemotherapy, and immunomodulatory drugs over the past year
History of allergies to plant compounds, including turmeric
High liver enzymes
Use of anticoagulants or antiplatelets (curcumin has an inhibitory effect on platelet aggregation) such as Warfarin, Aspirin, Clopidogrel, Epixaban, Rivaroxaban, Heparin and Enoxaparin
History of gastric ulcer and duodenal ulcer
Patients with inadequate literacy who do not understand the consent form</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Consumption of 2 oral sina Curcumin capsule 40 mg once a day for 1 month</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The recurrence of ulcers. Timepoint: 2, 4 and 8weeks after consumption of the medicine. Method of measurement: With physical examination of patients and based on the time after taking the drug that the disease will occurs again.</prim_outcome>
      <prim_outcome>The number of aphthous lesion. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Count the number of lesions through examination.</prim_outcome>
      <prim_outcome>Functional complications. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Use of visual analoge scale (VAS) from 0-10.  0: The least discomfort and interference of the lesions with the patient speaking, chewing and brushing. 10: The highest amount of interference.</prim_outcome>
      <prim_outcome>Patient satisfaction with treatment. Timepoint: 2, 4 and 8weeks after consumption of the medicine. Method of measurement: Use of visual analoge scale. 0-7: Dissatisfaction 8-10: Satisfaction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The size of aphthous lesion. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Using a sterile vernier caliper.</sec_outcome>
      <sec_outcome>The severity of pain. Timepoint: At the beginning of treatment and 2 weeks, 4 weeks and 8 weeks after consumption of the medicine. Method of measurement: Use of visual analoge scale (VAS) from 0-10. 0:no pain -  10: severe pain.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-01</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Science</contact_name>
        <contact_address>Assistance office of Research and Technology, Namjoo St.  Shahid Siadati St.,  in front of 17 Shahrivar hospital, Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
