<?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>IRCT20200428047229N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-15</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of compound honey syrup on the airways of cystic fibrosis patients Fractional exhalation Nitric Oxide</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of compound honey syrup on Fractional exhalation Nitric Oxide (FeNO) changes in Cystic Fibrosis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49518</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Cystic fibrosis.</hc_freetext>
      <i_freetext>Intervention group: After receiving informed consent from the parents of patients and children over 6 years of age, all standard and required drugs for cystic fibrosis patients are prescribed and in addition to the above treatments, the compound honey syrup is also prescribed. In the first visit (before starting the syrup) FeNO test, weight and height are taken from the patients and sputum culture is requested. Then compound honey syrup, 5-10 cc (depending on the age and weight of children) in 100 CC of boiled and lukewarm water is administered twice a day for 30 minutes after a meal for 6 weeks, and in weeks 2 and 4, the patient is followed up for the correct use of the drug. At 6 weeks, the patient is visited again, and the drugs and syrup are prescribed again for 6 weeks, and after that, the patient is followed up in the 8th and 10th weeks in terms of proper drug use. Finally, The patient is visited again in the 12th week, and FeNO test, weight and height are taken from the patients and also sputum culture is requested..</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:
Publishing results in the form of a Ph.D. thesis, an article indexing in ISI, and an article indexing in Pub Med

When:
After Ph.D. thesis defense

To whom:
Public

Conditions:
For research reasons

Where to obtain:
Shahid Beheshti University of Medical Sciences

How to obtain:
Approving by the responsible officer

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh Tahermohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>dr.hmohammadi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahpar Kaveh Bagh Bahadorani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>skaveh83@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All cystic fibrosis patients over 6 years of age should be referred to the pulmonary clinic of Mofid Children's Hospital, diagnosed by a pediatric lung specialist.
Conscious consent of parents of children and children over 6 years of age</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cystic fibrosis patients under 6 years of age referred to the pulmonary clinic of Mofid Children's Hospital
Patients in need of hospitalization
Patients who have attack symptoms of the disease (increased cough, sputum, fever, and need for hospitalization).
Patients with underlying diseases such as allergic bronchopulmonary aspergillosis, heart failure and tuberculosis.
Patients with other acute illnesses during treatment.
Patients who are allergic to any of the components of the compound honey syrup.
Patients who have decided to leave the study at their own request.
Patients who are unable to co-operate with the FeNO test.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cystic fibrosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After receiving informed consent from the parents of patients and children over 6 years of age, all standard and required drugs for cystic fibrosis patients are prescribed and in addition to the above treatments, the compound honey syrup is also prescribed. In the first visit (before starting the syrup) FeNO test, weight and height are taken from the patients and sputum culture is requested. Then compound honey syrup, 5-10 cc (depending on the age and weight of children) in 100 CC of boiled and lukewarm water is administered twice a day for 30 minutes after a meal for 6 weeks, and in weeks 2 and 4, the patient is followed up for the correct use of the drug. At 6 weeks, the patient is visited again, and the drugs and syrup are prescribed again for 6 weeks, and after that, the patient is followed up in the 8th and 10th weeks in terms of proper drug use. Finally, The patient is visited again in the 12th week, and FeNO test, weight and height are taken from the patients and also sputum culture is requested.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fractional exhalation Nitric Oxide. Timepoint: At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup. Method of measurement: FeNO monitor (NObreath®).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup. Method of measurement: Scales.</sec_outcome>
      <sec_outcome>Height. Timepoint: At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup. Method of measurement: Standing position and by meters.</sec_outcome>
      <sec_outcome>Body Mass Index (BMI). Timepoint: At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup. Method of measurement: Weight/(height)2.</sec_outcome>
      <sec_outcome>Staphylococcus aureus bacterial culture. Timepoint: At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup. Method of measurement: Preparation of sputum or throat swab after chest physiotherapy in the absence of sputum.</sec_outcome>
      <sec_outcome>Pseudomonas aeruginosa bacterial culture. Timepoint: At the beginning of the study (before the start of the intervention) and the twelfth week after the start of the compound honey syrup. Method of measurement: Preparation of sputum or throat swab after chest physiotherapy in the absence of sputum.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-28</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی</contact_name>
        <contact_address>خیابان یمن، دانشگاه علوم پزشکی شهیدبهشتی تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
