<?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>IRCT20120112008712N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-31</date_registration>
      <primary_sponsor>Maragheh University of Medical Sciences</primary_sponsor>
      <public_title>Kefir and Malva sylvestris in treatment of burning</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Adding Combination of Kefir and Malva sylvestris to Silver Sulfadiazine on Healing Time and Infection Rate in Second-degree Burning: Randomized Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40899</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization with computer software, Blinding description: َAll Patients, nurses, and doctors, as well as statistical analyzers, will be unaware of the treatment codes.</study_design>
      <phase>3</phase>
      <hc_freetext>Burn of second degree.</hc_freetext>
      <i_freetext>Intervention 1: In the control group: Before examining the wound, patients are examined by a physician based on a standard checklist. Then the limb or the burned area is washed with normal saline and dried by sterile gas. Silver sulfadiazine 1% ointment would be applied with sterile gloves on the wound. In this study, wound healing would be evaluated on days 1, 3, 7 and 14 after-burn. Intervention 2: In the intervention group: Before examining the wound, patients will be examined by a physician, based on a checklist. After washing and drying the burned tissue, kefir ointment and 10% extract of Malva sylvestris is applied to the wound area. Silver sulfadiazine 1% ointment is then applied and the wound will be dressed. In this study, wound healing would be evaluated on days 1, 3, 7 and 14 after-burn.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Farid alaaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Moallem</address>
        <city>Maragheh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5515878151</zip>
        <telephone>+98 41 3725 6920</telephone>
        <email>ghf.alaaei@yahoo.com</email>
        <affiliation>Maragheh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Ziaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Moallem</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5515878151</zip>
        <telephone>+98 41 3725 6930</telephone>
        <email>mjziaee@gmail.com</email>
        <affiliation>Maragheh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>2nd Degree Burning
Heat Burning
Burning area under 10%</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Over 6 hours of burning time
Age under 12 years old
1st degree burning or higher than 2nd degree
Chemical or Electrical Burning
Hypersensitivity to milk compounds, or combinations of drugs or dressing; Comorbidity.
Pregnancy or breastfeeding
People under chemotherapy or immunosuppressive drugs
Hemoglobin and total protein are less than normal.
The patient's wound is impregnated with contaminating material.
Burn in the facial and genital areas
Diabetic Patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T29.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burns of multiple regions, no more than second-degree burns mentioned</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the control group: Before examining the wound, patients are examined by a physician based on a standard checklist. Then the limb or the burned area is washed with normal saline and dried by sterile gas. Silver sulfadiazine 1% ointment would be applied with sterile gloves on the wound. In this study, wound healing would be evaluated on days 1, 3, 7 and 14 after-burn.</i_keyword>
      <i_keyword>In the intervention group: Before examining the wound, patients will be examined by a physician, based on a checklist. After washing and drying the burned tissue, kefir ointment and 10% extract of Malva sylvestris is applied to the wound area. Silver sulfadiazine 1% ointment is then applied and the wound will be dressed. In this study, wound healing would be evaluated on days 1, 3, 7 and 14 after-burn.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of burn wounds area. Timepoint: Area of wound at the beginning of the study (before the intervention) and on  3, 7 and 14 days, and then every 15 days until complete recovery. Method of measurement: Using a digital camera, the shot will be taken from the pre-dressing stage from 15 cm distance, and the area of the wound will be estimated using the AutoCAD software from the wound images.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Infection. Timepoint: Third, Seventh, Fourteenth and completed healing days. Method of measurement: microbial culture.</sec_outcome>
      <sec_outcome>Wound Scare. Timepoint: Third, Seventh, Fourteenth and completed healing days. Method of measurement: Digital Photography.</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>Maragheh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-13</approval_date>
        <contact_name>Ethics committee of Maragheh University of Medical Sciences</contact_name>
        <contact_address>North Moallem St., Maragheh, East Azerbaijan, Iran Maragheh East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
