<?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>IRCT20210915052490N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-10</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Triamcinolone and Jelfum in reducing the symptoms of allergic rhinitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparative survey of the effectiveness of topical injection of Triamcinolone and Jelfum with Triamcinolone on reducing the symptoms of patients with allergic rhinitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58760</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization method with unequal blocks (for example 2, 4, 6, etc.) will be used
 - Randomization unit: individual - How to build a random sequence: An equal number of each group will be placed in each block. In this way, first the list of all permutations related to the size of the desired block is determined and then will be randomly selected as many as the number of sample from permutation
 - Randomization tool: Random generation and selection of permutations done using reputable sites generate a block randomization list. Such as https://www.sealedenvelope.com
 - Hide method: use the envelope in the package.</study_design>
      <phase>1</phase>
      <hc_freetext>Allergic Rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Half a cc of Triamcinolone 40 ml Per mg is injected into the septum. Intervention 2: Intervention group: Jelfum impregnated with triamcinolone is placed Intranasally in the Middle meatus of the nose Both nostril nasal By Zero degree endoscope. Intervention 3: Control group: This group is treated routinely. Routine treatment will be washing serum and then nasal fluticasone spray, 2 puffs per nostril, every 6 hours (200 mg per day).</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:
All data is shared

When:
The access period starts one year after the results are published

To whom:
All researchers

Conditions:
Use for future research

Where to obtain:
Kermanshah University of Medical Sciences

How to obtain:
By Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amrollah Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine - University Street - Shahid Shiroodi Boulevard - Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714869914</zip>
        <telephone>+98 83 3427 4618</telephone>
        <email>amrollah.dehghani@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amrollah Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine - University Street - Shahid Shiroodi Boulevard - Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714869914</zip>
        <telephone>+98 83 3427 4618</telephone>
        <email>amrollah.dehghani@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ARIA Criteria Diagnosis of allergic rhinitis</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of rhinoplasty
Anatomical disorders of the nose
Persistent asthma
Prolonged use of corticosteroids
Tuberculosis
Diabetes
Chronic systemic diseases
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J30.8</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Half a cc of Triamcinolone 40 ml Per mg is injected into the septum.</i_keyword>
      <i_keyword>Intervention group: Jelfum impregnated with triamcinolone is placed Intranasally in the Middle meatus of the nose Both nostril nasal By Zero degree endoscope</i_keyword>
      <i_keyword>Control group: This group is treated routinely. Routine treatment will be washing serum and then nasal fluticasone spray, 2 puffs per nostril, every 6 hours (200 mg per day).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sneezing. Timepoint: At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention. Method of measurement: Based on question from the person (The rate of patient sneezing based on the number of episodes of the patient's daily sneezing).</prim_outcome>
      <prim_outcome>Runny nose. Timepoint: At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention. Method of measurement: Based on a question from the person (number of sheets of tissue paper consumed by the patient per day).</prim_outcome>
      <prim_outcome>Nasal congestion. Timepoint: At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention. Method of measurement: Based on the scores that patient gives to these symptoms from zero to three.</prim_outcome>
      <prim_outcome>Itchy nose. Timepoint: At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention. Method of measurement: Based on the scores that patient gives to these symptoms from zero to three.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-31</approval_date>
        <contact_name>Research Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology- Building No. 2  - Shahid Beheshti Boulevard  - Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
