<?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>IRCT20100829004655N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-17</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of pomegranate seed  extract on the improvement of stomatitis</public_title>
      <acronym>Pomeggranate seed extract and stomatitis</acronym>
      <scientific_title>The effect of mouth wash pomegranate seed extracts on improving oral mucositis in patients treated with chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30938</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 content   two glass:  1) the person who gave the glass to the patients and examine the  patients' oral mucosa  2) patients, Randomization description: Cancer patients who are continually referred to randomly assigned block randomization based on a computer spss program will be divided into two groups: intervention and control, Blinding description: Patients have no information about the kind of consultation that receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stomatitis.</hc_freetext>
      <i_freetext>Intervention 1: The intervantion group use solution of  routine + Pomegranate seed extract, each 100 cc containing lidocaine 2%, 50 mg (2.5.2 cc), 6 cc nystatin drop, Al-mg-s syrup 27.5 cc, Diphenhydramine 14 cc and 50 cc syrup of extract Pomegranate seed (50 to 50%) 4 times a day, for 14 days after breakfast, lunch, dinner, and before bed, 15 cc each time and keep it for 3 minutes, then These patients should not wash their mouths and give them an hour to eat food. Considering the two-sidedness of the study, oral mucosa on the first, seventh and fourteenth days by a nurse trained in the ancology department who does not lnow the mouthwash  solution and then checklist is completed . Intervention 2: Control group: Routine mouthwash (lidocaine 2% 100 mg (5 cc), 12 cc nystatin drop, AL-mg-s 55 cc, diphenhydramine syrup 28 cc) 4 times a day, for 14 days after breakfast, lunch, Dinner, and before bed, 15 cc each time and keep it for 3 minutes. Then they should be discarded. These patients should not wash their mouths and give them up to one hour of food intake, and according to double-blind In the study, the oral mucosa on the first, seventh and fourteenth days is checked by the nurse in the oncology nurse who is unaware of the type of mouthwash and the 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The total potential data can be shared after unidentifiable people

When:
Start the access period 6 months after printing the results

To whom:
Only available to scholars working in academia and academia

Conditions:
If you observe trust and mention the source, the data can be used by researchers

Where to obtain:
Send the following e-mail to the following address: taghadosi_m@Kaums.ac.ir

How to obtain:
After receiving the letter via email, your request will be reviewed within 2 weeks, and the data will be sent to the applicant at the discretion.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Taghadosi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arctic Blvd Ravandi, Kashan Universitr of Medical Sciences</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/81151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>taghadosi_m@Kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Taghadosi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arctic Blvd Ravandi , Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/81151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>taghadosi_m@Kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Undergoing chemotherapy
Having consciousness
Age above 18 years old
Satisfaction with participation in the study
Non-allergenic to herbal products</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Getting radiotherapy during research
Fever
Use of other mouthwashes other than mouthwashes defined in this study
The patient's decision to withdraw from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k12.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stomatitis</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>The intervantion group use solution of  routine + Pomegranate seed extract, each 100 cc containing lidocaine 2%, 50 mg (2.5.2 cc), 6 cc nystatin drop, Al-mg-s syrup 27.5 cc, Diphenhydramine 14 cc and 50 cc syrup of extract Pomegranate seed (50 to 50%) 4 times a day, for 14 days after breakfast, lunch, dinner, and before bed, 15 cc each time and keep it for 3 minutes, then These patients should not wash their mouths and give them an hour to eat food. Considering the two-sidedness of the study, oral mucosa on the first, seventh and fourteenth days by a nurse trained in the ancology department who does not lnow the mouthwash  solution and then checklist is completed .</i_keyword>
      <i_keyword>Control group: Routine mouthwash (lidocaine 2% 100 mg (5 cc), 12 cc nystatin drop, AL-mg-s 55 cc, diphenhydramine syrup 28 cc) 4 times a day, for 14 days after breakfast, lunch, Dinner, and before bed, 15 cc each time and keep it for 3 minutes. Then they should be discarded. These patients should not wash their mouths and give them up to one hour of food intake, and according to double-blind In the study, the oral mucosa on the first, seventh and fourteenth days is checked by the nurse in the oncology nurse who is unaware of the type of mouthwash and the checklist is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stomatitis. Timepoint: Before intervention, days 1, 7 and 14 after intervention. Method of measurement: Standardized checklist stomatitis WHO.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change grade of stomatitis. Timepoint: Before intervention, days 1, 7 and 14 after intervention. Method of measurement: Standardized checklist stomatitis WHO.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-30</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>kashan University of Medical Sciences , Km 5  ghotb Radvandi Blvd. Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
