<?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>IRCT20220107053656N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-30</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Aesculus hippocastanum extract on the prevention of phlebitis induced by peripheral intravenous catheters</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect Aesculus hippocastanum extract on the prevention of phlebitis induced by peripheral intravenous catheters</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75696</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done as available and 100 patients will be divided into two intervention and control groups (50 people in each group) by simple random allocation using block of four software, Blinding description: This study is a randomized and double-blind clinical trial (researchers and patients). In this way, the filling of the containers containing worms was done by someone other than the researcher or the sampler in the laboratory, and the containers of worms were named A and B for blinding, but blinding was not done for the statician.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Phlebitis induced by peripheral intravenous catheters.</hc_freetext>
      <i_freetext>After the placement of peripheral catheters (Angioket No. 20) in the test group, Indian chestnut extract (Worm Worm) on the skin of the angioket insertion site measuring 3x3 cm and in the placebo cream control group, on the skin of the angioket insertion site measuring 3x3 cm centimeter will be placed and it will be covered by a sterile cover (angioket glue). Daru Nama cream will be prepared by the pharmaceutical laboratory of Iranian School of Medical Sciences in Tehran. In order to blind patients and researchers to the intervention, both cream and placebo will be packed in similar containers and will be provided to the researcher. The occurrence of phlebitis and its degrees will be checked within 72 hours from the time of placing angioket and cream, at zero, 24 and 48 hours.The examination of the position in 24-hour intervals in terms of the occurrence and severity of phlebitis will be done by one of the researchers and one of the colleagues working in the relevant department to ensure reliability between the two evaluators. Based on the study design and ethical considerations, in both groups after examining the position using the visual scale of phlebitis in terms of its development and severity, the samples will be excluded from the study as soon as grade 2 or more phlebitis develops in them, and only samples They will remain in groups with phlebitis of 0 and 1.</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>Arpi Manookian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of medical-surgical nursing School of Nursing and Midwifery of Tehran University of Medical Sciences, East Nosrat street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>ar-manookian@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arpi Manookian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of medical-surgical nursing School of Nursing and Midwifery of Tehran University of Medical Sciences, East Nosrat street</address>
        <city>Tehrah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>ar-manookian@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hospitalization in the wards of Shariati Hospital for at least 72 hours
Age between 18 and 60 years
IV-line implantation in a vein of the upper limb in a place without signs of phlebitis
72-hour IV-line implantation
Patient being awake</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from diabetes mellitus
Suffering from skin disorders and types of eczema
Suffering from systemic vascular disease
Suffering from severe anemia
Suffering from immunodeficiency diseases
Allergic to iv-line adhesive
Undergoing chemotherapy
Receiving oral non-steroidal anti-inflammatory drugs, injections and suppositories
Receiving intravenous amiodarone, and heparin and  nitroglycerin
Suffering from acute and chronic infectious diseases
Having fever and receiving antibiotic treatment to eliminate fever
Allergic to chestnut products</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After the placement of peripheral catheters (Angioket No. 20) in the test group, Indian chestnut extract (Worm Worm) on the skin of the angioket insertion site measuring 3x3 cm and in the placebo cream control group, on the skin of the angioket insertion site measuring 3x3 cm centimeter will be placed and it will be covered by a sterile cover (angioket glue). Daru Nama cream will be prepared by the pharmaceutical laboratory of Iranian School of Medical Sciences in Tehran. In order to blind patients and researchers to the intervention, both cream and placebo will be packed in similar containers and will be provided to the researcher. The occurrence of phlebitis and its degrees will be checked within 72 hours from the time of placing angioket and cream, at zero, 24 and 48 hours.The examination of the position in 24-hour intervals in terms of the occurrence and severity of phlebitis will be done by one of the researchers and one of the colleagues working in the relevant department to ensure reliability between the two evaluators. Based on the study design and ethical considerations, in both groups after examining the position using the visual scale of phlebitis in terms of its development and severity, the samples will be excluded from the study as soon as grade 2 or more phlebitis develops in them, and only samples They will remain in groups with phlebitis of 0 and 1</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phlebitis. Timepoint: Hours: 0,24,48 and 72. Method of measurement: Visual Infusion Phlebitis scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-28</approval_date>
        <contact_name>Ethics committee in research of school of nursing midwifery rehabilitation</contact_name>
        <contact_address>Nosrat, Tohid, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
