<?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>IRCT20080831001138N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-09</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Matricaria Chamomilla on Quality of Life in Patients with Chronic Rhinosinusitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of Matricaria Chamomilla on Quality of Life in Patients with Chronic Rhinosinusitis Referred to Amiralmounin Hospital in Rasht</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The clinical trial has two groups of cases and controls, Randomization description: In this way at first, before the start of the study, the Random Allocation software gives a list of random numbers that is evenly divided into two groups A and B to a third party, each of them in separate closed envelopes according to the list. If the patient is referred to and qualified, one of the envelopes is given to the patient according to the number and after filling the forms, the envelope is opened and the patient is placed in one of the groups and receives the corresponding medication. Patients will not inform about the received medication, Blinding description: In order to maintain blindfolded of the study, both patients and researchers associated with patients will be unaware of the patient's drug intake (in the clinic, one researcher will distribute and record the drug to the patient, and the other researcher will evaluate the patients. Medications will look quite similar in shape, color and size.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic rhinosinusitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, chamomile extract was prepared by maceration method. Patients use 3 drops of the extract in each nostril after washing each nostril with 10 cc normal saline three times a day. Intervention 2: Control group: washes the nose with 10 cc normal saline in each nostril three times a day then uses sesame seed oil as a placebo and three drops per nostril. All patients will be taught how to properly use drug and nasal washing.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Shadman Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralamomenin Hospital, 17 Shahrivar St</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41396-37459</zip>
        <telephone>+98 13 1222 5242</telephone>
        <email>nemati@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shadman Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralamomenin Hospital, 17 Shahrivar St</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41396-37459</zip>
        <telephone>+98 13 1222 5242</telephone>
        <email>nemati@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years old
Having at least reading and writing skills
Having chronic rhinosinusitis according to the diagnosis of ENT</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
History of sinus and nasal surgery
Usage of corticosteroid drugs continuously and daily
History of nasal polyp
Lund-Mackay scores above 14 in sinus CT
Rhinosinusitis Chronic exacerbation requires antibiotics
History of any sensitivity to chamomile or its compounds
Usage of drugs such as ciclosporin, aspirin, warfarin and heparin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic sinusitis</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: In this study, chamomile extract was prepared by maceration method. Patients use 3 drops of the extract in each nostril after washing each nostril with 10 cc normal saline three times a day</i_keyword>
      <i_keyword>Control group: washes the nose with 10 cc normal saline in each nostril three times a day then uses sesame seed oil as a placebo and three drops per nostril. All patients will be taught how to properly use drug and nasal washing</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the treatment, the first week, second week, third week. Method of measurement: Information obtained from the Sino-Nasal Outcome Test (SNOT-22) Questionnaire and biographies.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-03</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>vice-chancellor for Research Building, opposite of Sepah Bank,Shahid Beheshti Blvd Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
