<?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>IRCT20180729040630N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-11</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Local Effect of  sheep ghee on complication after Angiography</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the Local Effect of bovine ghee on complication after Angiography in Patients Under Coronary Angiography Admitted to Ali-ibn Abitaleb Hospital in Rafsanjan City in 2018-2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33202</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random block, Blinding description: This study is a double blind study. Participants and researchers are unaware of the allocation of study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Complications after Angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cow oil. Intervention 2: Intervention group: Sheep oil. Intervention 3: Control group: Vaseline cream.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ali Zakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafsanjan, Imam Ali Bolvar</address>
        <city>Rafsangan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34 3428 0011</telephone>
        <email>mazakeri@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali  Zakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Ali Bolvar, Rafsanjan</address>
        <city>Rafsangan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34342316</telephone>
        <email>ma.zakeri115@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing coronary angioplasty                       Performing angiography via femoral artery                                Lack of heart failure                                                           Lack of COPD                                                                                     Lack of kidney failure                                                                      Lack of severe valve disease                                                              Lack of liver failure                                                                    Lack of Blood disorders                                                                                  Using Sheath 6 to access the artery pathway                                     Not having known psychiatric disorders                                 Fluency in Farsi and ability to communicate                                Systolic blood pressure is less than 130                                                                               Lack of ecchymosis in the angiography site                                                                  Lack of hematoma in the angiography site                                                                                            Lack of hemorrhage in the angiography site                                                                              Not taking steroids, heparin and enoxaparin                                Age more than 18 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug side effects                                                                       History of localized allergy to animal oil                                       The incidence of non-vascular complications of Angiography in the patient                                                               Types of cardiac dysrhythmia                                            Contrast agents                                                              Cardiac tamponed                                                                                                                                           Cerebrovascular accident (CVA)                                                             Pulmonary edema                                                                        Cardio-respiratory arrest                                                       Decreased consciousness                                                                   Angioplasty Emergency Surgery                                                     Lack of cooperation                                       Personal satisfaction and discharge</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D69.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bleeding</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cow oil</i_keyword>
      <i_keyword>Intervention group: Sheep oil</i_keyword>
      <i_keyword>Control group: Vaseline cream</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complication after Angiography. Timepoint: Before and after intervention. Method of measurement: Christenson's guideline, Visual Satisfaction Scale of Patients, Visual Scale of Pain And Fatigue Assay Scale for Routine Patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction of Patients. Timepoint: Before and after intervention. Method of measurement: Visual Satisfaction Scale of Patients.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Before and after intervention. Method of measurement: Visual analogue pain scale.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-23</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Imam Ali Bulvar, Rafsanjan. Rafsangan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
