<?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>IRCT20181208041882N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-06</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of  curcumin gel effevtiveness in prophylaxis of radiation dermatitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of 2% curcumin gel effevtiveness in prophylaxis of radiation dermatitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49228</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, simple randomization method was used. Patients were randomly assigned to two groups by using Random.org site, Blinding description: In this study patients, clinical caregivers and outcome assessors were unaware of the type of medication patients were receiving. Patients in both groups received the medication in the same package.</study_design>
      <phase>3</phase>
      <hc_freetext>Dermatitis caused by breast radiation therapy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Curcumin gel 2% twice daily from the first day        Radiation therapy The patient receives one of the same gels topically for four weeks. Made in Yazd University of Medical Sciences. Intervention 2: Control group: Placebo gel twice daily from the first day        Radiation therapy The patient receives one of the same gels topically for four weeks. Made in Yazd University of Medical Sciences.</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:
After nonrecognition all data can be share

When:
6 months after publication

To whom:
All of researchers

Conditions:
Nothing

Where to obtain:
Dr.Behrooz Heydari email :b.heydari@ssu.ac.ir

How to obtain:
Request your informationby email :The data will be sent after a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behrooz Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blv Alem Sq</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173143</zip>
        <telephone>+98 35 3820 3410</telephone>
        <email>b.heydari@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behrooz Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blvd Alem Sq</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173143</zip>
        <telephone>+98 35 3830 3410</telephone>
        <email>b.heydari@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women 18 to 65 years old to get started breast radiation therapy has been referred to Shahid Ramezanzadeh Radiotherapy Center in Yazd</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with skin diseases
People who are allergic to curcumin
People with severe systemic diseases such as uncontrolled diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Radiodermatitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Curcumin gel 2% twice daily from the first day        Radiation therapy The patient receives one of the same gels topically for four weeks. Made in Yazd University of Medical Sciences</i_keyword>
      <i_keyword>Control group: Placebo gel twice daily from the first day        Radiation therapy The patient receives one of the same gels topically for four weeks. Made in Yazd University of Medical Sciences</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of redness. Timepoint: The severity of the redness begins with treatment   Redness intensity in the first week Redness intensity in the second week Redness intensity in the third week and redness intensity in the fourth week after starting treatment. Method of measurement: RTOG standard scale.</prim_outcome>
      <prim_outcome>Itching intensity. Timepoint: The severity of itching begins treatment      Severity of itching in the first week Severity of itching in the second week Severity of itching in the third week and severity of itching in the fourth week after starting treatment. Method of measurement: Based on a question from the patient.</prim_outcome>
      <prim_outcome>Intensity of burning. Timepoint: Severe onset of burning of treatment of severity of burning in the first week, severity of burning in the second week, severity of burning in the third week, and severity of burning in the fourth week after starting treatment. Method of measurement: Based on a question from the patient.</prim_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Intensity of pain Initiation of treatment Intensity of pain The first week   Pain intensity in the second week Pain intensity in the third week and pain intensity in the fourth week after starting treatment. Method of measurement: Based on a question from the patient.</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>دانشگاه علوم پزشکی یزد</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-06</approval_date>
        <contact_name>Ethics committee of yazd university of medical sciences</contact_name>
        <contact_address>Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blve Alem Sq Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
