<?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>IRCT20190312043027N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-14</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effects of Plantago Major on prevention of radiation induced acute mucositis</public_title>
      <acronym></acronym>
      <scientific_title>The effects of Plantago Major compared to placebo on prevention of radiation induced acute mucositis in head and neck cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38541</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomize individual blocks using random numbers, Blinding description: Drug and placebo in the form of syrup and without mentioning the name of the drug in the pharmacy company Sanabel , affiliated to the Center for Clinical Trial Research of Traditional Medicine, Shahed University, was provided by a third person who did not participate in the rest of the study. 
The investigator and team conducting research and evaluating outcomes, as well as participants, did not know the type of contents of syrup bottles.</study_design>
      <phase>3</phase>
      <hc_freetext>Radiation-induced mucositis in head and neck cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Plantago syrup, three times per day,after each meal, each serving 7.5 cc, for 7 weeks. Intervention 2: Control group: Placebo syrup, three times per day, after each meal, each serving 7.5 cc, for 7 weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is I Will be Decided For Information Publication</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Mohammadsoltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.158, Mahvash Alley., Shariati St., Khomeini Shahr., Isfahan Province.</address>
        <city>Khomeini Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84147-36631</zip>
        <telephone>+98 31 3362 4574</telephone>
        <email>rezamohammadsoltani@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Mohammadsoltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.158 , Mahvash Alley.,Shariati St.,  Khomeini Shahr.,Isfahan Province</address>
        <city>Khomeini Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84147-36631</zip>
        <telephone>+98 31 3362 4574</telephone>
        <email>rezamohammadsoltani@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate for radiotherapy for head &amp; neck cancer
Patients with 17-65 years old
Life expectancy over 1 year
Good performance status in Eastern Cooperative Oncology Group  (ECOG) questionnaire
At least 4 areas in radiotherapy (RT) ﬁelds</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Using  alcohol
Use of drugs aﬀecting salivary gland secretions,such as antidepressants, Opiates, anti-hypertensives, anti-histamines.
Use of mouthwash solutions
Smoking
History of mouth and oropharynx radiation therapy and chemotherapy in the last six months.
History of connective tissue diseases affecting salivary glands such as  Sjugren syndrome , Rheumatoid arthritis and Lupus and immunodeficiency diseases
Grade 3-4 mucositis
Candidiasis, oral herpes
Hospitalization or need to Total Parental Nutrition ( TPN)
Dissatisfaction to continue participating in the study
Treatment failed
Diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oral mucositis (ulcerative)</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: Plantago syrup, three times per day,after each meal, each serving 7.5 cc, for 7 weeks.</i_keyword>
      <i_keyword>Control group: Placebo syrup, three times per day, after each meal, each serving 7.5 cc, for 7 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mucositis. Timepoint: Baseline of radiation therapy; every week after initiation of radiation therapy for 5 weeks and two weeks after intervention terminated. Method of measurement: Examination of oral cavity.</prim_outcome>
      <prim_outcome>Pain. Timepoint: At the baseline and every week from first to seventh. Method of measurement: Visual analogue scale of pain.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: At the baseline and every week from first to seventh. Method of measurement: EORTC questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side eﬀects. Timepoint: Every week from first to seventh. 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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-19</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Basij Square.,  Arak.,  Markazi Province. Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
