<?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>IRCT20161017030336N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-23</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of savory essential oil on diabetic wounds</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of herbal supplement prepared from savory essential oil on diabetic wounds in patients with diabetic wounds</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61338</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to the fact that this plan is not blind, the control and intervention groups are selected by simple random method, so that patients are numbered in the order of admission to the hospital in numbers from one to twenty, the first 10 admitted group We consider the intervention and the second 10 admitted people are considered as the control group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Unspecified diabetes mellitus with peripheral circulatory complications. Condition 2: Wound complication.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Washing the wound with normal saline, spraying safflower essential oil on the wound with a spray, and then sterile gauze impregnated with safflower essential oil is placed on the wound and bandaged. Depending on the patient's condition, this is a maximum of one or two times a day dressing of patients and the next time a day dressing of standard treatment according to the specialized principles of treatment, wounds are bandaged. Intervention 2: Control group: Rinse the wound with normal saline, spray sterile distilled water on the wound with a sprayer, and then sterile gauze soaked in sterile distilled water is placed on the wound and bandaged. Depending on the patient's condition, this is a once-daily dressing of the patients, and the next time the dressing is applied from the standard treatment according to the specialized principles of treatment, the wounds are bandaged.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghasem Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak - Imam Khomeini Square - Imam Khomeini Boulevard - 3 km of Khomeini Road - Amirkabir University Town Growth and Technology Center</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3836119131</zip>
        <telephone>+98 86 3341 2101</telephone>
        <email>ghasemhabibi.chem@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Bandarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar St., Shahrivar St., corner of Hiyat St., Diabetes Clinic, Floor 5, Diabetes Research Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1441716411</zip>
        <telephone>+98 21 8833 8742</telephone>
        <email>fbandarian@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Proven diabetes
Clinical findings that indicate wound infection such as redness, swelling, and discharge
Presence of ulcers in the extremities of patients
Having a body mass index of 18 to 35
Having full consciousness upon entering the study</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug and alcohol abuse
Having a chronic disease other than diabetes that affects the healing process of wounds such as severe vascular disease, lupus, rheumatoid arthritis, burgers and kidney failure
Consumption of immunosuppressants
Cancer and the use of cytotoxic drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
      <hc_code>T81.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
      <hc_keyword>Disruption of wound, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Washing the wound with normal saline, spraying safflower essential oil on the wound with a spray, and then sterile gauze impregnated with safflower essential oil is placed on the wound and bandaged. Depending on the patient's condition, this is a maximum of one or two times a day dressing of patients and the next time a day dressing of standard treatment according to the specialized principles of treatment, wounds are bandaged</i_keyword>
      <i_keyword>Control group: Rinse the wound with normal saline, spray sterile distilled water on the wound with a sprayer, and then sterile gauze soaked in sterile distilled water is placed on the wound and bandaged. Depending on the patient's condition, this is a once-daily dressing of the patients, and the next time the dressing is applied from the standard treatment according to the specialized principles of treatment, the wounds are bandaged.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Degree of diabetic foot ulcer. Timepoint: Before the intervention and every week for up to four weeks after the intervention. Method of measurement: The degree and depth of diabetic wounds in centimeters in both control and test groups are assessed by the researcher.</prim_outcome>
      <prim_outcome>Duration of treatment. Timepoint: Before the intervention and every week for up to four weeks after the intervention. Method of measurement: The degree and depth of diabetic wounds in centimeters in both control and test groups are assessed by the researcher.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-07</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Arak Branch</contact_name>
        <contact_address>Imam Khomeini Square, Imam Khomeini Boulevard, 3 km of Khomeini Road, Amirkabir University Town Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
