<?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>IRCT20190114042353N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-16</date_registration>
      <primary_sponsor>Vice-Chancellor of Research Affairs, Guilan University of Medical Sciences</primary_sponsor>
      <public_title>clinical effectiveness of mouthwash of arctium lappa tincture on the treatment of oral mucositis induced by chemoradiotherapy in patients with head and neck cancer</public_title>
      <acronym></acronym>
      <scientific_title>clinical effectiveness of mouthwash of arctium lappa tincture on the treatment of oral mucositis induced by chemoradiotherapy in patients with head and neck cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37035</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using a random number table, Blinding description: after accepting participation In the study,a bottle containing a mixture of burdock mouthwash and a diphenhydramine mouthwash was given to the patient that the patient was not aware of its contents.</study_design>
      <phase>2-3</phase>
      <hc_freetext>oral mucositis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Mouthwash burdock Tincture + Diphenhydramine mouthwash:The patient should hold 30 drops of mouthwash with some  water in his mouth every day, four times a day,  and then throw it out.(Before using this mouthwash, they should also use diphenhydramine combination mouthwash).as they should, First, keep 30 drops of mouthwash for 30 seconds and then throw it away.After 30 minutes, use the second mouthwash in the manner described. Intervention 2: Control group: Diphenhydramine combination mouthwash:The patient takes 30 drops of diphenhydramine mouthwash four times a day for 30 seconds in his mouth then throw it away.</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 Care for the secrets of patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anahid Lavayii Motlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan University of Medical Sciences,2km Fouman Road,Lakan Road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4194173774</zip>
        <telephone>+98 13 3348 6406</telephone>
        <email>dr.anahid@yahoomail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>masood sepehri manesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Center Lab,Razi Hospital,Sardar Jangal Ave,Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448</zip>
        <telephone>+98 13 3353 5116</telephone>
        <email>sepehrimaneshmasood@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with head and neck cancer who go to oncology department of"Razi Hospital"</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any systemic disorder that may interfere with the repair process (such as diabetes)
History of allergy to Arauca family
Pregnant and lactating women
Continuous users of analgesics</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Mouthwash burdock Tincture + Diphenhydramine mouthwash:The patient should hold 30 drops of mouthwash with some  water in his mouth every day, four times a day,  and then throw it out.(Before using this mouthwash, they should also use diphenhydramine combination mouthwash).as they should, First, keep 30 drops of mouthwash for 30 seconds and then throw it away.After 30 minutes, use the second mouthwash in the manner described.</i_keyword>
      <i_keyword>Control group: Diphenhydramine combination mouthwash:The patient takes 30 drops of diphenhydramine mouthwash four times a day for 30 seconds in his mouth then throw it away.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of pain. Timepoint: at the first of study before intervention, then it is measured every week for 6 weeks. Method of measurement: Based on the VAS index.</prim_outcome>
      <prim_outcome>Severity of lesion. Timepoint: at the first of study before intervention, then it is measured every week for 6 weeks. Method of measurement: Based on the WHO Scale.</prim_outcome>
      <prim_outcome>Treatment duration. Timepoint: Total days from the onset of 3-4 degree mucositis symptoms. Method of measurement: Number of days.</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>Vice-Chancellor of Research Affairs, Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-19</approval_date>
        <contact_name>Ethics committee of research center of Guilan University of Medical sciences</contact_name>
        <contact_address>Guilan University of Medical Sciences.,Lakan Road Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
