<?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>IRCT2013092214729N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-31</date_registration>
      <primary_sponsor>Vice chancellor for research, Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of mouth wash containing yarrow plant  extract on improvement stomatitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of mouth wash containing yarrow plant extract and routine solution on improvement stomatitis in cancer patients receiving  chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14277</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, the following people were blind and did not know of the contents two glass (glass 1: extract yarrow + 2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2% and glass 2: 2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) .&#13;
1) The person who gave the glass to the patient&#13;
2) A person who has examined the oral mucosa.&#13;
3) Patients.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Stomatitis.</hc_freetext>
      <i_freetext>Intervention 1: Case 1: a experimental group solution containing extract yarrow-routine solution (2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) (glass 1) is given will. Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. According to a triple blind study, oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed. Intervention 2: Case 2: a control group routine solution containing (2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) (glass 2) is given will. Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. According to a triple blind study, oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.</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>Leyla Soleymanpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87155/111</zip>
        <telephone>+98 33 4635 2622</telephone>
        <email>Leylalegla@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh Miranzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan -  Ghotb Ravandi Blvd.</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81755/111</zip>
        <telephone>+98 36 1555 2999</telephone>
        <email>S_Miranzadeh@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: informed consent for participation in the study, aged 20 years and older, no underlying disease (allergy, allergic rhinitis, asthma ), not receive radiation therapy after diagnosis, having consciousness, not use another mouthwash solution during the study, and not receiving systemic antibiotics and antifungals. Exclusion criteria: receiving radiotherapy during treatment, fever, use from another solution mouthwash during the study, the decision to withdraw from the study, irregular use of mouthwash solution (frequency, amount), solution containing extract yarrow odor intolerance by patients and received systemic antibiotics and antifungals at the beginning or during the study.</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>149 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k12.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stomatitis and related lesions</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>Case 1: a experimental group solution containing extract yarrow-routine solution (2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) (glass 1) is given will. Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. According to a triple blind study, oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.</i_keyword>
      <i_keyword>Case 2: a control group routine solution containing (2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) (glass 2) is given will. Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. According to a triple blind study, oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stomatitis. Timepoint: Before and seventh and fourteenth  days after the intervention. Method of measurement: Standardized checklist stomatitis WHO.</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 for research, Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-30</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ghotb Ravandi Blvd Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
