<?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>IRCT20220516054879N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-03</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effects of Hypericum Perforatum and Dexpanthenol topical cream on the  healing process of scar</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effects of Hypericum Perforatum and Dexpanthenol topical cream on the  healing process of scar caused  by neck surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70216</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The 4 permutation block randomization method was used to randomize patients into two groups. Given that Group A is the intervention group and Group B is the control group. Randomization was done with SAS software version 9.
For allocation concealment, opaque-sealed envelopes will be used, Blinding description: This is a double-blind study. Comparison of color and smell between Hypericum and Dexpanthenol creams will be done using allowed color and essential oil. The type of treatment will be placed inside a sealed envelope and delivered to the nurse and statistical analyst. The researcher and the participant will be blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Scar caused by neck surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Receiving 3 times a day topical cream formulation of Hypericum perforatum plant with 70% ethanolic extract with 2% concentration of total extract for 3 months. Intervention 2: Control group: Receiving 3 times a day Dexpanthenol 5% topical cream from Raha Pharmaceutical Company for 3 months.</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 Patient privacy and ethical principles</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Shahrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17shahrivar Hospital, Shahid Siadati Street, Namjoo Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>414465379</zip>
        <telephone>+98 13 3336 9019</telephone>
        <email>shahrokhi.mail85@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Shahrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17shahrivar Hospital, Shahid Siadati Street, Namjoo Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144654379</zip>
        <telephone>+98 13 3336 9019</telephone>
        <email>shahrokhi.mail85@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with neck wounds caused by surgery
After removing the stitches
obtaining informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous sensitivity to products containing Hypericum Perforatom
Receiving other drugs effective on wound healing
Suffering from diseases that interfere with wound healing (chronic systemic diseases of the heart, kidney, lung, coagulation disorder, immune deficiency, connective tissue disorder, diabetes, anemia, hemophilia, and malnutrition)
Having a history of previous injury or surgery and visible lesions in the neck area</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L90.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Scar conditions and fibrosis of skin</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:  Receiving 3 times a day topical cream formulation of Hypericum perforatum plant with 70% ethanolic extract with 2% concentration of total extract for 3 months.</i_keyword>
      <i_keyword>Control group: Receiving 3 times a day Dexpanthenol 5% topical cream from Raha Pharmaceutical Company for 3 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scar spread. Timepoint: Scar spread will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on the observation of the researcher.</prim_outcome>
      <prim_outcome>Erythema. Timepoint: Erythema will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on the observation of the researcher.</prim_outcome>
      <prim_outcome>Dyspigmentation. Timepoint: Dyspigmentation will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on the observation of the researcher.</prim_outcome>
      <prim_outcome>Track marks or suture marks. Timepoint: Track marks or suture marks will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on the observation of the researcher.</prim_outcome>
      <prim_outcome>Hypertrophy/atrophy. Timepoint: Hypertrophy/atrophy will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on the observation of the researcher.</prim_outcome>
      <prim_outcome>Overall impression. Timepoint: Overall impression will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on the observation of the researcher.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Pain  will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on questions from the patient.</prim_outcome>
      <prim_outcome>Itch. Timepoint: Itch  will be measured at the beginning of the study and then weekly for 3 months. Method of measurement: Based on questions from the patient.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-03</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, In front of 17 shahrivar hospital, Shaid siadati street,Namjoo street, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
