<?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>IRCT20230104057046N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-12</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of the effect of mouthwashes containing tranexamic acid and nanotrangasemic acid in leukemia patients</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of mouthwashes containing tranexamic acid and nanotransexamic acid for controlSpontaneous intraoral bleeding in leukemia patients: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68923</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We select patients from those who refer to the Desiani clinic of Golestan University of Medical Sciences according to the study entry and exit criteria. Then, based on the severity of the disease, we divide them into two groups, moderate and weak, and enter the names in a double list (in the form of a and b) in the Excel software. Then, the names are sorted separately based on random numbers for each list, and assigned to each of the drug groups one by one, Blinding description: The participants are unaware of the allocation of study groups. Bottles containing medicine are the same for both control and intervention groups. The intervention and control groups are divided into A and B, and the test participants have no knowledge of the type and group to be tested.</study_design>
      <phase>3</phase>
      <hc_freetext>Spontaneous oral bleeding in leukemia patients.</hc_freetext>
      <i_freetext>Intervention group The intervention group receives five percent nanotrangasmic acid mouthwash. Each subject will receive 4 containers of 280 ml containing mouthwash. Each patient is taught to use 20 ml mouthwash four times a day for 14 days. The participant is allowed to eat half an hour after using the mouthwash. The mouthwashes are made by pharmacists and experts in the nano field who are present as consultants in the project..</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>Aliye sensebli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Makhtumaghli 24، Attaabad,</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4938134820</zip>
        <telephone>+98 17 3450 2115</telephone>
        <email>aliyesensebli@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazanin Mortazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrear 5، Shahrear town</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4938134820</zip>
        <telephone>+98 17 3450 2115</telephone>
        <email>dr.mortazavi@webmail-goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Leukemia patients with oral bleeding
Patients diagnosed with thrombocytopenia (platelet count less than 20,000 units)
Selection of patients with the same frequency of use as assigned random classification
Selection of patients with the same interval of chemotherapy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of any anti-coagulant or anti-coagulant drugs (such as ASA, NSAID, ...) in the last month
Pregnant or nursing mothers
Hypersensitivity to tranexamic acid
Use of birth control pills
Smokers
Presence of severe periodontitis
The presence of diseases that prohibit the use of anticoagulants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C95</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Leukemia of unspecified cell type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group The intervention group receives five percent nanotrangasmic acid mouthwash. Each subject will receive 4 containers of 280 ml containing mouthwash. Each patient is taught to use 20 ml mouthwash four times a day for 14 days. The participant is allowed to eat half an hour after using the mouthwash. The mouthwashes are made by pharmacists and experts in the nano field who are present as consultants in the project.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of times of spontaneous oral bleeding؛ the presence of spontaneous oral bleeding؛ the number of bleeding interdental areas after using an interdental toothbrush by the researcher. Timepoint: Measuring the number of bleeding interdental areas before the start of the intervention and 14 days after the start of the intervention؛ Measuring the number of bleeding times before and after using mouthwash (every day up to two weeks)؛ Identifying the presence of oral bleeding before and after using mouthwash (every day up to two weeks ). Method of measurement: Evaluation of the presence of bleeding by questionnaire - Evaluation of the number of bleeding areas by the researcher through interdental toothbrushes - Evaluation of the number of bleeding times by 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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-17</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Philosophical Higher Education Complex، the beginning of the Sixty Hats Road، Gorgan Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
