<?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>IRCT20200301046653N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-10</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Zoush herbal ointment in burn treatment</public_title>
      <acronym></acronym>
      <scientific_title>Cilinical Study the Effect of Zoush in Comperhansive Sulfadiazine 1 Ointment on Second-degree Burned Wound Healing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46257</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Second-degree Burned Wound.</hc_freetext>
      <i_freetext>Intervention group: in order to prepare the ointment of safflower herbs, thyme, Shiraz, oregano is purchased from the Barij essential oils and alcoholic extract. Finally, the extracts are powdered from the same company. The constituents of the extracts were measured using gas chromatography. The extracts are dissolved in a ratio of 1/3 in dimethyl sulfoxide. Honey is dissolved in distilled water in a ratio of 1/3. Polyurethane is dissolved in 6 m urea at a ratio of 1/3 and then subjected to indirect heat to evaporate urea. Extracts of Khuzestani, Thyme, and Oregano soluble, DMSO water-soluble honey and polyurethane soluble in urea are mixed in a separate falcon in a ratio of one to one and used as the primary stack of zush ointment compounds in other stages. Will take. Zucchini ointment will be used daily for 21 days..</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:
Information about the results and data of the study subjects can be shared.

When:
The access period begins 6 months after the results are published.

To whom:
Data will be available only to researchers working in universities.

Conditions:
Data recipients can only read and reference the article. And any misuse of the results is subject to prosecution as the drug formulation is patented.

Where to obtain:
Applicants may request to receive study data by emailing the principal investigator nazarimahdi90@gmail.com and phone number 09126474345

How to obtain:
After receiving the email from the Principal Investigator, the data will eventually be sent to the applicant's workplace at the relevant medical university within 30 working days.

Comments:
Given that this research project has been the result of an effort in the animal phase since 1993, it is only possible to use the data from the clinical trial of this study in compliance with existing rules and regulations.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, No. 50, Next to East Laleh First Health Park, Boulevard Imam Khomeini, Ferdis</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3143843711</zip>
        <telephone>+98 26 3680 4015</telephone>
        <email>nazarimahdi90@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Haj Maghsoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Burn Clinic, Madani Hospital, Madani Square, Jahanshahr, Karaj Town</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11111111111111</zip>
        <telephone>+98 26 3680 4015</telephone>
        <email>L.hajimaghsoudi@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy female or male volunteers aged 20 to 50 years old
Be willing to participate in research and be able to answer questions
Has read and signed the informed consent form</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have underlying illnesses such as diabetes and immune deficiencies such as cancer, AIDS
Have severe skin allergies and skin problems
People who use cigarettes and alcohol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T23.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn of second degree of wrist and hand</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in order to prepare the ointment of safflower herbs, thyme, Shiraz, oregano is purchased from the Barij essential oils and alcoholic extract. Finally, the extracts are powdered from the same company. The constituents of the extracts were measured using gas chromatography. The extracts are dissolved in a ratio of 1/3 in dimethyl sulfoxide. Honey is dissolved in distilled water in a ratio of 1/3. Polyurethane is dissolved in 6 m urea at a ratio of 1/3 and then subjected to indirect heat to evaporate urea. Extracts of Khuzestani, Thyme, and Oregano soluble, DMSO water-soluble honey and polyurethane soluble in urea are mixed in a separate falcon in a ratio of one to one and used as the primary stack of zush ointment compounds in other stages. Will take. Zucchini ointment will be used daily for 21 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The size of the wound includes the depth and edge of the wound and the extent of the wound. Timepoint: Study days 7, 14 and 21. Method of measurement: BATES JENSIN Wound Questionnaire.</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-04</approval_date>
        <contact_name>Ethics Committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Unit 3, No. 50, Next to East Laleh First Health Park, Boulevard Imam Khomeini, Ferdis, Karaj karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
