<?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>IRCT2016061416925N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-26</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect  of Origanum Vulgaris L. on Allergic Rhinitis.</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of Origanum Vulgaris L. Effect on Allergic Rhinitis Compared to Placebo: a randomized-controlled clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15702</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Allergic Rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group uses Origanum Vulgaris L. Extract; nasal spray, 40g/20ml, 2 puff, 3 times/day, for 1 month. Intervention 2: Control group uses placebo for 1 month.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Morteza Emami Alorizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences, Zand Ave., Shiraz, Fars, Iran.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>713451978</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>smemami@sums.ac.ir, morteza.emami@ymail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Hesamedin Nabavizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Hospital, Zand St, Shiraz, Iran.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>719335899</zip>
        <telephone>+98 71 3612 2267</telephone>
        <email>drhesamnabavi@yahoo.com</email>
        <affiliation>Allergy Research Center.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: men and women aged 18 to 60 years old; outpatients with a history or diagnosis of allergic rhinitis for at least 6 months before the first visit; allergic rhinitis and the numbers of eosinophil in the nasal mucous or the skin Prick test is proven (if not already done during the last 6 months); signing informed consent; patients with a diagnosis of allergic rhinitis are previous topical or systemic treatments include antihistamines and corticosteroids have not responded or those with complications who have had previous with these drugs, do not want or cannot be treated with these drugs are; no anatomical abnormalities in the nose (nasal polyp or severe deviation); drugs that are used to treat allergies and if they use, it must be discontinued before the study; patients who are able to read and understand the consent form; ; patients who have not dementia; are not pregnant or are able to communicate and patients without nasopharyngeal tumors; patients who have not a history of drug allergy with Origanum vulgare.&#13;
Exclusion criteria: patients taking drugs other than drugs that must consume according to the research plan, the duration of the project will be excluded from use; patients during the study have a fungal, viral or bacterial disease; patients who do not follow the recommended instructions will be excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J30-J39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of upper respiratory tract</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 uses Origanum Vulgaris L. Extract; nasal spray, 40g/20ml, 2 puff, 3 times/day, for 1 month.</i_keyword>
      <i_keyword>Control group uses placebo for 1 month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The overall clinical symptoms. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Severity of rhinorrhea. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Severity of itchy nose. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Severity of nasal obstruction. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Frequency of sneezing per day. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Severity of itchy palate. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Severity of eye symptoms. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Number of nose palate eosinophils. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Rhinitis Quality of Life Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Assessment of allergic rhinitis symptoms recovery based on the international diagnostic criteria of rhinitis quality of life questionnaire. Timepoint: Before the intervention and after intervention once a week, for a month. Method of measurement: Questionnaire.</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>2016-08-07</approval_date>
        <contact_name>Shiraz University of Medcal Sciences</contact_name>
        <contact_address>Shiraz University of Medcal Sciences(Central Building), Zand Ave. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
