<?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>IRCT20230718058831N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-28</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>short term prednisolon in itp</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Efficiency of Short-Term and Two-Week Oral Prednisolone Use to Manage Newly Diagnosed Immune Thrombocytopenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71368</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Treatment Patients with acute  immune thrombocytopenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The study is designed in the form of a coincidental and open label. All patients with a newly diagnosed immune thrombocytopenic condition were aged 1 month to 15 years and had a platelet count of less than 109 × 20 per liter after obtaining informed consent from the parent Sadfi ward group took cannde long short duration prednizolon diet With a daily dosing regimen of 2 mg/kg of oral prednisolone on days 1 to 7 without drug dose titration, platelets were weighed during treatment on days 3, 14 and 30 during blood cell count testing. Similarly, 2 months after the start of treatment, patients were examined and response to treatment was given. Patients could be excluded from the study in any time they chose. Intervention 2: Intervention group: The study is designed as a randomized and open label format. All patients with a newly diagnosed immune thrombocytopenic condition were aged 1 month to 15 years and had a blood platelet count of less than 109 × 20 per liter after obtaining parental consent The group was given two weeks of dietary prednisolone .. Patients' platelets were measured before the start of the appointment and registration period and drugs were measured in mg/kg2 on 14 days and then from days 14 to 21 doses and titration were performed. Platelet counts were performed on days 3, 14 and 30 during treatment. Similarly, 2 months after the start of treatment, patients were examined and response to treatment was given. Patients could be excluded from the study in any time they chose.</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>Khatere Tavajohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No4 ,four baharestan,pasdaran blvd,tehran town</address>
        <city>تهران</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1689887961</zip>
        <telephone>+98 912 050 4872</telephone>
        <email>khtavajohi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khatere Tavajohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4 ,ashkan,four baharestan,pasdaran blvd,tehran town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1689887961</zip>
        <telephone>+98 21 2222 7021</telephone>
        <email>Khtavajohi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>childeren with acuteImmune Thrombocytopenia</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with  active infections and septicemia
patients with positive antinuclear antibody
patients with Evans syndrome
Patients with chronic immune thrombocytopenia
Patients with positive glue culture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D69.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Immune thrombocytopenic purpura</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:The study is designed in the form of a coincidental and open label. All patients with a newly diagnosed immune thrombocytopenic condition were aged 1 month to 15 years and had a platelet count of less than 109 × 20 per liter after obtaining informed consent from the parent Sadfi ward group took cannde long short duration prednizolon diet With a daily dosing regimen of 2 mg/kg of oral prednisolone on days 1 to 7 without drug dose titration, platelets were weighed during treatment on days 3, 14 and 30 during blood cell count testing. Similarly, 2 months after the start of treatment, patients were examined and response to treatment was given. Patients could be excluded from the study in any time they chose.</i_keyword>
      <i_keyword>Intervention group: The study is designed as a randomized and open label format. All patients with a newly diagnosed immune thrombocytopenic condition were aged 1 month to 15 years and had a blood platelet count of less than 109 × 20 per liter after obtaining parental consent The group was given two weeks of dietary prednisolone .. Patients' platelets were measured before the start of the appointment and registration period and drugs were measured in mg/kg2 on 14 days and then from days 14 to 21 doses and titration were performed. Platelet counts were performed on days 3, 14 and 30 during treatment. Similarly, 2 months after the start of treatment, patients were examined and response to treatment was given. Patients could be excluded from the study in any time they chose</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Platelet count of patients after a short course of prednisolone. Timepoint: Comment on the number of blood platelets at different time points before the start and days 2, 7, 30 and 60 after the start of the treatment period. Method of measurement: Compelete blood count.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-27</approval_date>
        <contact_name>Ethics Committee of Medical Students of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>No 4 . four baharestan,pasdaran blvd,tehran town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
