<?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>IRCT20211205053277N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Montelukast in allergic rhinitis, Evaluation of the effect of neotadine in the treatment of allergic rhinitis</public_title>
      <acronym>TMNS</acronym>
      <scientific_title>Comparison of the effect of montelukast with the usual dose of twice as much neotadine with intranasal mometasone in allergic rhinitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60408</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were equally assigned to 4 groups using the permuted block method. In this way, each treatment group was assigned a code (the codes are A for the group receiving neotadine once a day, B for receiving neotadine twice a day, C for receiving montelukast and D for the group receiving neotadine and Montelukast).
Then, a random number from 1 to 24 was assigned to different states of the blocks (ABCD, ABDC, ACDB,...), which were 24 states in total. After that, using the Random Sequence Generator software, random numbers were obtained and the order of the blocks in a list was determined. The blocks and numbers are as follows: ABCD for number 1, ABDC for number 2, ACBD for number 3, ACDB for number 4, ADBC ​​for number 5, ADCB for number 6, BACD for number 7, BADC for number 8, BCAD for number 9, BCDA for number 10, BDAC for number 11, DBAC for number 12, BDCA for number 13, CABD for number 14, CADB for number 15, CDAB for number 16, CDBA for number 17, CBAD for number 18, CBDA for number 19, DABC for number 20, DACB for number 21, DCAB for number 22, DCBA for number 23, DBCA for number 24,((It should be noted that this list is predetermined and after the sample size is determined, the allocation will be done up to the fifteenth block of 4 according to the number of samples in each group. In this way, 15 people will be included in each group.).</study_design>
      <phase>2-3</phase>
      <hc_freetext>allergic rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: The patients in the first group will be treated by mometasone nasal spray with a dose of 100 micrograms (two puffs in each nose) daily for 8 weeks along with 5 mg desloratadine tablets every night for 8 weeks by a specialist. Intervention 2: Patients in the second group will be treated by mometasone nasal spray with a dose of 100 micrograms (two puffs in each nose) daily for 8 weeks along with 5 mg desloratadine (Neotadine) 1 tablet twice a day for 8 weeks by a specialist. Intervention 3: Patients in the third group will be treated with mometasone nasal spray at a dose of 100 micrograms (two puffs in each nose) daily for 8 weeks along with oral Montelukast tablets 5 mg daily for two months. Intervention 4: Patients in the fourth group will be treated with mometasone nasal spray at a dose of 100 micrograms (two puffs in each nostril) daily for 8 weeks, along with 5 mg oral Montelukast tablets and 1 desloratadine tablet for 8 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The informed consent form and data analysis spss file will be shared.

When:
Access starts 6 months after results are published

To whom:
The data will be available to academic and scientific institutions

Conditions:
In order to be used in scientific articles and the optimal use of drugs in the course of treatment

Where to obtain:
Refer to Bahrami Hospital and the people whose names are given in this plan

How to obtain:
The people named in this plan should be emailed as information will be available as soon as possible

Comments:
...</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Niloufar Ghanbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabalan street , AnsarAlhosein Ave</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1641744991</zip>
        <telephone>+98 21 7756 8801</telephone>
        <email>niloufargh67@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Alireza Shafii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabalan street , Ansaralhosein Ave</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1641744991</zip>
        <telephone>+98 21 7301 3000</telephone>
        <email>ar.shafii@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having moderate to severe allergic rhinitis
over 6 years of age
having informed consent</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Asthma infection and adenoid hypertrophy
Patients with chronic diseases
Antihistamine use during the last 1 month
Systemic or topical corticosteroids
History of neotadine allergy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J30.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other allergic rhinitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The patients in the first group will be treated by mometasone nasal spray with a dose of 100 micrograms (two puffs in each nose) daily for 8 weeks along with 5 mg desloratadine tablets every night for 8 weeks by a specialist.</i_keyword>
      <i_keyword>Patients in the second group will be treated by mometasone nasal spray with a dose of 100 micrograms (two puffs in each nose) daily for 8 weeks along with 5 mg desloratadine (Neotadine) 1 tablet twice a day for 8 weeks by a specialist.</i_keyword>
      <i_keyword>Patients in the third group will be treated with mometasone nasal spray at a dose of 100 micrograms (two puffs in each nose) daily for 8 weeks along with oral Montelukast tablets 5 mg daily for two months.</i_keyword>
      <i_keyword>Patients in the fourth group will be treated with mometasone nasal spray at a dose of 100 micrograms (two puffs in each nostril) daily for 8 weeks, along with 5 mg oral Montelukast tablets and 1 desloratadine tablet for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nasal symptom score. Timepoint: before treatment intervention and two months after treatment. Method of measurement: Nasal symptom scoring table.</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>Tehran University of Medical Scince</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-23</approval_date>
        <contact_name>national system of ethics in biomedical research</contact_name>
        <contact_address>Bahrami hospital , Ansaralhosein ave , south Sabalan , Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
