<?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>IRCT20171030037093N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-11</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of immunotherapy with aeroallergens and drug treatment in patients with allergic rhinitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of immunotherapy with aeroallergens and drug treatment in patients with allergic rhinitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40400</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the study, simple randomization with individual unit was used, so that patients randomly selected one of the cards containing the code A or B so they entered one of the two treatment groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Allergic rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients received the usual drug treatment, including inhaled glucocorticoids (Fluticasone) and antihistamines once a day for one month. Intervention 2: Intervention group: Patients who had a positive prick test underwent immunotherapy with allergen extract with three vials diluted 1: 10,000 pg per week for 10 sessions, 1: 1000 pg every other week for 10 sessions and then dilution of 1: 100 pg every month for 2 years.</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:
Information on the main outcome can be shared.

When:
Start the access period 4 months after publishing the results

To whom:
Researchers working in academia

Conditions:
Use data to complete clinical trial studies

Where to obtain:
Kashani Hospital in Shahrekord, zamani.m@skums.ac.ir

How to obtain:
After the investigation of resercher request and presentation of required documents will be accessible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ali Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815713471</zip>
        <telephone>+98 38 3334 2414</telephone>
        <email>zamani.m@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815713471</zip>
        <telephone>+98 38 3227 4004</telephone>
        <email>zamani.m@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 10 and over 10 years
Age less than 50 years
Lack of advanced and severe asthma
Negative pregnancy test for women
Lack of autoimmune disease
Lack of immunodeficiency disease
Lack of malignancy</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient lack of cooperation
Continuous use of immunosuppressive drugs
Continuous use of antihistamines
Taking beta-blocker medications
History of allergy to each of the treatment groups</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J30.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Allergic rhinitis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients received the usual drug treatment, including inhaled glucocorticoids (Fluticasone) and antihistamines once a day for one month.</i_keyword>
      <i_keyword>Intervention group: Patients who had a positive prick test underwent immunotherapy with allergen extract with three vials diluted 1: 10,000 pg per week for 10 sessions, 1: 1000 pg every other week for 10 sessions and then dilution of 1: 100 pg every month for 2 years.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sneeze. Timepoint: Before intervention, 2 years after intervention. Method of measurement: Checklist containing clinical symptoms.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Before intervention, 2 years after intervention. Method of measurement: Checklist containing clinical symptoms.</prim_outcome>
      <prim_outcome>Rhinorrhea. Timepoint: Before intervention, 2 years after intervention. Method of measurement: Checklist containing clinical symptoms.</prim_outcome>
      <prim_outcome>Itchy eyes. Timepoint: Before intervention, 2 years after intervention. Method of measurement: Checklist containing clinical symptoms.</prim_outcome>
      <prim_outcome>Itchy throat. Timepoint: Before intervention, 2 years after intervention. Method of measurement: Checklist containing clinical symptoms.</prim_outcome>
      <prim_outcome>Post nasal discharge. Timepoint: Before intervention, 2 years after intervention. Method of measurement: Checklist containing clinical symptoms.</prim_outcome>
      <prim_outcome>Nasal congestion. Timepoint: Before intervention, 2 years after intervention. Method of measurement: Checklist containing clinical symptoms.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-22</approval_date>
        <contact_name>Ethics Committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
