<?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>IRCT20100218003361N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-30</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Platanus orientalis L. distillate effects on allergic rhinitis</public_title>
      <acronym></acronym>
      <scientific_title>The clinical efficacy of Platanus orientalis L. distillate, as nasal drop, in allergic rhinitis- a pilot, randomized,  double-blind, placebo-controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35498</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization method was applied. Random allocation software was used. Equal block sizes were used and based on the sample size (30) and two treatment groups, eight permuted blocks of four were produced. In this method, the number of test and control cases is equal in each block. All of the randomized permuted blocks of 4 are noted and in each step one of them is selected randomly, Blinding description: Subjects and study personnel (including principal investigator) were blinded in this study. Nasal drops in placebo and test group were prepared in identical packages (with a number based on the randomization method) by research center personnel who were not associated with the subject’s clinical management, data collection and analysis, to ensure blinding.
Because of the similar packaging, placebo and test drops were not distinguishable.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Allergic rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Platanus Orientalis L. distillate, prepared as nasal drop. It is applied 4 times a day for one month. Distillate is prepared in research center and is filled in the drop containers following filtration. Intervention 2: Control group: distilled water.</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 Researchers have not decided about the data publication yet. They decide to publish the data as article and they would published the data which are required ethically.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Soheila Alyasin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 36122268</telephone>
        <email>alyasins@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Soheila Alyasin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 71 3612 2268</telephone>
        <email>alyasins@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18-65 years
Obtaining the informed consent
Fulfillment of allergic rhinitis diagnostic criteria and the history of allergic rhinitis for at least two consecutive years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic corticosteroid therapy in the past three months
Local corticosteroid therapy in the past fifteen days
Pregnancy
Breast feeding
Females at age of fertility with no particular pregnancy prevention method</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Platanus Orientalis L. distillate, prepared as nasal drop. It is applied 4 times a day for one month. Distillate is prepared in research center and is filled in the drop containers following filtration.</i_keyword>
      <i_keyword>Control group: distilled water</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Allergic rhinitis symptom score (nose, eyes, respiratory). Timepoint: Daily. Method of measurement: Filling the daily symptom questionnaire and symptom scores by the patient.</prim_outcome>
      <prim_outcome>Comparing the daily mean scores of allergic rhinitis. Timepoint: Day 1- Day 30. Method of measurement: Statistical analyses.</prim_outcome>
      <prim_outcome>Quality of life score (regular activities, recreational activities, sleep). Timepoint: At enrollment, at days 14 and 30. Method of measurement: Quality of life scoring in quality of life questionnaire.</prim_outcome>
      <prim_outcome>Observing the variations in the severity of allergic rhinitis symptoms. Timepoint: Day 30. Method of measurement: Clinician evaluations.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-27</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
