<?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>IRCT201308127494N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-03-11</date_registration>
      <primary_sponsor>Vice chancellor for research of Mazandaran University of Medical Science</primary_sponsor>
      <public_title>Effects of sesame oil on prevention of phlebitis caused by peripheral vein infusion of amiodarone.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of sesame oil on prevention of phlebitis caused by peripheral vein infusion of amiodarone in cardiac patient.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7958</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>phlebitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention1: In the experimental group, at first the catheterization is performed observing aseptic conditions.Then before the injection of first dose of Amiodarone, as 5 drops of pure sesame oil (produced by Barij Essence,Kashan,Iran) will be rubbed around 10 cm around the area of intravenous Amiodarone injection are applied. And then Amiodarone infusion start and sesame oil will be rubbed every 6 hours during 24 hours (4 times) in the area.Essance,Kashan,Iran) as 5 drops of around 10 cm in the path where the intravenous amiodarone injection are applied. And then amiodarone infusion start and sesame oil is applied every 6 hours to 24 hours(4 times) in the area. Intervention 2: Intervention2: In control group will be rubbed liquid paraffin (produced by MERK.Germany.cod:1.07160) as placebo. The amount and method of using liquid paraffinis as exactly same as using of sesame oil inthe experimental group.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mohamad Ali Heydari Gorji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery,Vesal St, Amir St, Sari.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 15 1326 1245</telephone>
        <email>heydarigorji@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari, Mazandaran.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 15 1226 7342</telephone>
        <email>anna3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion major criteria; being over 18 years old; don't have any history of allergy to the sesame seeds; using of the upper extremity for intravenously catheterization. &#13;
Exclusion major criteria; having autoimmunity disease; using analgesics and narcotics to mitigate the pain continuously; using drugs or herbal oil to prevent phlebitis during the study; Bradicardia and death of the patient.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phlebitis and thrombophlebitis of other sites</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>Intervention1: In the experimental group, at first the catheterization is performed observing aseptic conditions.Then before the injection of first dose of Amiodarone, as 5 drops of pure sesame oil (produced by Barij Essence,Kashan,Iran) will be rubbed around 10 cm around the area of intravenous Amiodarone injection are applied. And then Amiodarone infusion start and sesame oil will be rubbed every 6 hours during 24 hours (4 times) in the area.Essance,Kashan,Iran) as 5 drops of around 10 cm in the path where the intravenous amiodarone injection are applied. And then amiodarone infusion start and sesame oil is applied every 6 hours to 24 hours(4 times) in the area</i_keyword>
      <i_keyword>Intervention2: In control group will be rubbed liquid paraffin (produced by MERK.Germany.cod:1.07160) as placebo. The amount and method of using liquid paraffinis as exactly same as using of sesame oil inthe experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phlebitis. Timepoint: Before and during the study-Phlebitis will be measure consecutive 30 hours in each group. Method of measurement: visual infusion phlebitis scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Prevention of phlebitis. Timepoint: after intervention, Phlebitis will be measure consecutive 30 hours in each group. Method of measurement: Visual infusion phlebitis Scale (VIP).</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>Vice chancellor for research of Mazandaran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-05</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research of Mazandaran University of Medical Science, Moalem square , Moalem street ,Sari. Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
