<?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>IRCT20200104045995N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-01</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Ventilation on Burn Healing</public_title>
      <acronym></acronym>
      <scientific_title>Determination of the effectiveness of proderm herbal ointment in comparison withnitrofurazone cream in second degree burn wounds</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44743</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this method, the number of people assigned to each group is usually equal. In this method, blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as controls. The main goal of this method is to balance the number of participants in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with second-degree burns.</hc_freetext>
      <i_freetext>Intervention 1: The effect of a patented topical formulation containing standardized extracts of the medicinal plant Hawachobeh, castor oil and olive oil formulated in Danesh Banain Andisheh Sabalan Health Company and in healing wounds caused by second degree burns in comparison with nitrofurazone cream will be investigated. In such a way that two types of treatments include 1- use of nitrofurazone cream on second degree burns 2- use of proderm ointment on second degree burns that in both treatments of the burn site (hands, feet and face) cause and type of burn are common. The statistical population for each group of 30 people in the age range of 2 to 50 years of those referred to the burn ward of Fatemi Hospital who have burns on similar limbs (in terms of organ and burn site) and those who have burns on the back and abdomen They will be removed. Consumption of prodermal drug 2-3 mm in the burn site after washing with standard serum is applied topically on the wound once a day with sterile gas. Intervention 2: Control group: Patients with second-degree burns for whom nitrofurazone cream will be used daily.</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:
All data includes the primary and secondary consequences that can be shared.

When:
6 months after printing the results.

To whom:
Our data will only be available to researchers working in academia and academia.

Conditions:
Our data will be available to researchers working in academic and scientific institutions.

Where to obtain:
Hamed Arastegi provides data to applicants via email hamedaraz69@gmail.com.

How to obtain:
Collecting patients and performing practical procedures for ten months, collecting data for one month, analyzing statistical data for one month, publishing information in the form of a six-month article.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad vakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۶۱۴۷۳۳۷۷۵</zip>
        <telephone>+98 45 3323 9033</telephone>
        <email>mohammad.vakili@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad vakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۶۱۴۷۳۳۷۷۵</zip>
        <telephone>+98 45 3323 9033</telephone>
        <email>mohammad.vakili@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a second degree burn wound
The shape of the burn wound is almost oval and regular
Burn with boiling water, fire and acid.</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an underlying disease such as epilepsy
Having a history of autoimmune diseases; Getting HIV
History of taking immunosuppressive drugs
History of psychotic disorder such as paranoid
Hospitalization history in the psychiatric ward</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The effect of a patented topical formulation containing standardized extracts of the medicinal plant Hawachobeh, castor oil and olive oil formulated in Danesh Banain Andisheh Sabalan Health Company and in healing wounds caused by second degree burns in comparison with nitrofurazone cream will be investigated. In such a way that two types of treatments include 1- use of nitrofurazone cream on second degree burns 2- use of proderm ointment on second degree burns that in both treatments of the burn site (hands, feet and face) cause and type of burn are common. The statistical population for each group of 30 people in the age range of 2 to 50 years of those referred to the burn ward of Fatemi Hospital who have burns on similar limbs (in terms of organ and burn site) and those who have burns on the back and abdomen They will be removed. Consumption of prodermal drug 2-3 mm in the burn site after washing with standard serum is applied topically on the wound once a day with sterile gas.</i_keyword>
      <i_keyword>Control group: Patients with second-degree burns for whom nitrofurazone cream will be used daily</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound size. Timepoint: The first day and every other day until the wound is completely healed. Method of measurement: To mm using calipers.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wound healing rate. Timepoint: The first day and every other day until the wound is completely healed. Method of measurement: Wound imaging.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>شرکت اندیشه سلامت سبلان</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ardabil University of Medical Sciences</source_name>
      <source_name>شرکت اندیشه سلامت سبلان</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-03</approval_date>
        <contact_name>Ethics Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Daneshgah St. Daneshgah ardebil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
