<?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>IRCT20160516027929N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the efficacy and side effects of desloratadine with fexofenadine on allergic rhinitis in patients referred to Masih Daneshvari Hospital</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy and side effects of desloratadine with fexofenadine on allergic rhinitis in patients referred to Masih Daneshvari Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54017</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization, randomization unit: individual, randomization tool: table of random numbers, To construct a random sequence with the help of a random number table and by the statistical consultant, patients accidentally had one of the even and odd codes. Patients who were assigned even numbers were in the first group and patients with odd codes were in the second group, Blinding description: The drugs are placed in bags that are similar in appearance and are labeled as groups A and B. The patient is unaware of this labeling (aware of receiving medication but kept blind to group assignments). Also, the project partner who distributes the medicine is not aware of this labeling. To avoid any possible complications, the lead researcher is aware of the assignment of groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Allergic rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first group, patients receive 5 mg of desloratadine daily for 4 weeks.After 2 weeks of no drug treatment, they are treated with fexofenadine 120 mg daily for 4 weeks. Intervention 2: Intervention group: In the second group, patients received 120 mg of fexofenadine daily for 4 weeks. After two weeks of no drug treatment, they are treated with desloratadine.</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 currently no program</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Fakharian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>(Niavaran), Darabad, Shahid Bahonar St.</address>
        <city>: Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 5050</telephone>
        <email>fakharian_2005@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Fakharian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>(Niavaran), Darabad, Shahid Bahonar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 5050</telephone>
        <email>fakharian_2005@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 12 years
History of allergic rhinitis or diagnosis at first visit
Written consent to participate in the study</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity, allergy or adverse reaction to desloratadine and fexofenadine
Patients who have previously been treated with two or more drugs
pregnancy and breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J30.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Allergic rhinitis due to pollen</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: In the first group, patients receive 5 mg of desloratadine daily for 4 weeks.After 2 weeks of no drug treatment, they are treated with fexofenadine 120 mg daily for 4 weeks.</i_keyword>
      <i_keyword>Intervention group: In the second group, patients received 120 mg of fexofenadine daily for 4 weeks. After two weeks of no drug treatment, they are treated with desloratadine.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>General clinical symptoms. Timepoint: Before starting treatment and 10 weeks after starting treatment. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>The severity of eye symptoms. Timepoint: Rhinitis Quality of Life Questionnaire. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Severe itching in the nose. Timepoint: Rhinitis Quality of Life Questionnaire. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Sleep disorders. Timepoint: Rhinitis Quality of Life Questionnaire. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluation of the clinical symptoms of allergic rhinitis. Timepoint: Before starting treatment and 10 weeks after starting treatment. Method of measurement: Physical examination.</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>2020-09-22</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Arabi St., Yemen St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
