<?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>IRCT20211219053449N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-16</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of Cetirizine and Desloratadine on the symptoms of chronic spontaneous urticarial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of Cetirizine and Desloratadine on the symptoms of chronic spontaneous urticarial and quality of life</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62242</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization. Using software and 4, 6 and 8 size blocks for hiding, the cards that identify the intervention and control group are prepared and then placed in opaque envelopes and the envelopes are arranged and numbered according to the sequence produced by the software and the patients are arranged accordingly. Admission (envelope number one for the first patient and two for the second, etc.) are assigned to the intervention or comparison group according to the card in the envelope.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic urticaria.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: prescription of cetirizine tablets from Abidi pharmaceutical company in 4 times the standard dose for 2 weeks. Intervention 2: Intervention group 2: Administration of Desloratadine tablets from Abidi  pharmaceutical company in 4 times the standard dose for 2 weeks.</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 no further information avaible</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Khoshkhui</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>daneshgah str.</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3840 0000</telephone>
        <email>KhoshkhuiM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>maryam Khoshkhui</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>daneshgah str.</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3840 0000</telephone>
        <email>KhoshkhuiM@mums.ac.i</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The purpose of the study will be explained to all patients and written informed consent will be obtained.
CSU patients with a history of chronic spontaneous urticaria for at least six weeks during the last three months
who did not respond to standard doses of second-generation antihistamines
the illness was not controlled according to the disease questionnaire.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Drug-induced urticaria
Vasculitis urticaria
Hereditary angioedema
Colitis urticaria
Physical urticaria
cold urticaria</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Urticaria</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 1: prescription of cetirizine tablets from Abidi pharmaceutical company in 4 times the standard dose for 2 weeks</i_keyword>
      <i_keyword>Intervention group 2: Administration of Desloratadine tablets from Abidi  pharmaceutical company in 4 times the standard dose for 2 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>UCT questionnaire score: assessment of pruritus and urticaria symptoms. Timepoint: before and after 14 days of taking the drug. Method of measurement: UCT questionnaire.</prim_outcome>
      <prim_outcome>CU-QoL questionnaire: assessment of quality of life. Timepoint: At the beginning of the study and 2 weeks after taking the drug. Method of measurement: Chronic Urticaria-Quality of Life Questionnaire (CU-QoL).</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>Dr. Abidi Pharmaceuticals</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-31</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences</contact_name>
        <contact_address>university street mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
