<?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>IRCT2015112425217N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-31</date_registration>
      <primary_sponsor>Vice Chancellery for Research of Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of a herbal medicine combinations in the treatment of chronic sinusitis</public_title>
      <acronym>TPM: Traditional Persian Medicine, EP3OS: European Position Paper on Rhinosinusitis and Nasal Polyp</acronym>
      <scientific_title>Elucidation of sinusitis based on Traditional Persian Medicine (TPM) and comparison of the TPM therapeutic protocol efficacy on chronic sinusitis with classic treatment: Mixed Methods</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21121</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic sinusitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Oral drug: Marjoram  and licorice herbal tea, dose: 5 grams of pack contains 3 grams of leaves of marjoram and 2 grams of licorice root, every 8 hours, the duration of treatment (consumption): 8 weeks; If there is no improvement in symptoms for up to 12 weeks will continue. How to use: patient should be infuse the contents of each packet with 200 ml of boiling water in the pot for 20 minutes and after clearing, to be drink slowly at a temperature close lukewarm to hot , divided by maintaining an hour away from food, . Local drug: Lavender oil on base of olive oil, dosage: 3-2 drops once a day (at night), the duration of treatment (consumption): 8 weeks; if there is no improvement in symptoms for up to 12 weeks will continue. Education: patients of this group on the basis of written instructions that will be placed at their disposal, will be avoided from harmful foods for cold and catarrh (such as yogurt, buttermilk, cheese, dough bread , bananas, vinegar, ...). Intervention 2: Control group: Prescription drugs include: Inhaled corticosteroid (Fluxinase), at a rate of 2 inhalations per day; along with daily nose irrigation with normal saline in the morning and evening. If there is no improvement, a systemic steroids will be administrated (prednisone tablets 1 mg / kg; that will be tapered within a short time). If there is evidence of purulent sinusitis, antibiotic treatment with azithromycin capsules of 250 mg daily for 4 weeks will be added to the treatment protocol.</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>Dr. Mohammad Reza Mehri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional and Complementary Medicine, Razi sharghi Ave., 10 Dey Sq.,  Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51385521889</telephone>
        <email>Mehrimr1@mums.ac.ir;  Drmrmehri@yahoo.com</email>
        <affiliation>Mashhad University of Medical Sciences, Faculty of Traditional and Complementary Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Majid Anushiravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional and Complementary Medicine, Razi sharghi Ave., 10 Dey Sq.,  Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51385521889</telephone>
        <email>dr.anushiravani@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences, Faculty of Traditional and Complementary Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Two criteria of the main criteria (including: nasal obstruction or congestion; anterior or posterior nasal secretion; facial pain or pressure; and reduction or loss of smell) or one major criterion and two minor criteria (including dental pain; cough; pain; pressure or fullness feel in ears; fatigue; headache or halitosis) for more than 12 weeks during the past 12 months.&#13;
Exclusion criteria: Chronic sinusitis along with acute bacterial infections of the respiratory tract; Chronic sinusitis along with anatomical obstructions requiring surgery; Sensitivity or contraindication to the drug components; Pregnancy; Immunodeficiency; The presence of high blood pressure (hypertension history or blood pressure on admission greater than 140/90 mm Hg)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>J32Chronic sinusitis Incl.: abscess, empyema, infection, suppuration (chronic) of sinus (accessory)(nasal</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Oral drug: Marjoram  and licorice herbal tea, dose: 5 grams of pack contains 3 grams of leaves of marjoram and 2 grams of licorice root, every 8 hours, the duration of treatment (consumption): 8 weeks; If there is no improvement in symptoms for up to 12 weeks will continue. How to use: patient should be infuse the contents of each packet with 200 ml of boiling water in the pot for 20 minutes and after clearing, to be drink slowly at a temperature close lukewarm to hot , divided by maintaining an hour away from food, . Local drug: Lavender oil on base of olive oil, dosage: 3-2 drops once a day (at night), the duration of treatment (consumption): 8 weeks; if there is no improvement in symptoms for up to 12 weeks will continue. Education: patients of this group on the basis of written instructions that will be placed at their disposal, will be avoided from harmful foods for cold and catarrh (such as yogurt, buttermilk, cheese, dough bread , bananas, vinegar, ...).</i_keyword>
      <i_keyword>Control group: Prescription drugs include: Inhaled corticosteroid (Fluxinase), at a rate of 2 inhalations per day; along with daily nose irrigation with normal saline in the morning and evening. If there is no improvement, a systemic steroids will be administrated (prednisone tablets 1 mg / kg; that will be tapered within a short time). If there is evidence of purulent sinusitis, antibiotic treatment with azithromycin capsules of 250 mg daily for 4 weeks will be added to the treatment protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of chronic sinusitis. Timepoint: Baseline and sixth, eighth and twelfth week after intervention. Method of measurement: SNOT22 Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Paranasal sinuses status. Timepoint: Before the intervention and twelve weeks after beginning intervention. Method of measurement: Lund-Mackey Score.</sec_outcome>
      <sec_outcome>Symptoms of cold Coryza (Zokam) and Catarrh (Nazlah). Timepoint: Before the intervention and twelve weeks after intervention beginning. Method of measurement: cold Coryza (Zokam) and Catarrh (Nazlah) 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>Vice Chancellery for Research of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-07</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ethics committee of Mashhad University of Medical Sciences, Central office of Mashhad University of Medical Sciences, Daneshgah Ave., Mashhad, Iran Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
