<?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>IRCT20190315043059N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-31</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Scrophularia Striata on Breast Fissure of Lactating women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Scrophularia Striata Plant on Breast Fissure of Lactating women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38520</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the number cruncher statistical system (NCSS) software, the samples will randomly assign to one of the two groups of Scrophularia striata and lanolin, Blinding description: Patients became blind because of the appearance and color of the ointment. Due to lack of knowledge about the random allocation of patients to thei ntervention 1 and 2 group, the researcher was blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Breast Fissure.</hc_freetext>
      <i_freetext>Intervention 1: intervention group1: In the intervention group1 after breastfeeding 1gr Scrophularia striata cream will be rubbed to the nipple and areola 3 times a day for 7 days. Intervention 2: intervention group2: in the intervention group two after breastfeeding 1gr Lanolin cream will be rubbed to the nipple and areola 3 times a day for 7 days.</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 The release plan is not yet available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirreza Nasirzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691933577</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>nasirzadeharnz@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Ebrahimisenu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691933577</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>hamid.ebrahimi7050@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single-child delivery
A term and healthy infant and exclusive breast milk nutrition
Birth weight of infant between 2500 to 4000 grams</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Abnormality of mouth, palate, jaw or face in infant
Mother's disease to known underlying diseases (diabetes or any type of internal-surgical disease)
History of nipple abnormalities (flat or inverted nipples or any nipple malformation which is followed by burning or any history of nipple and areola operation in childhood)
History of identified mental illnesses in mother</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N64.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fissure and Fistula of Nipple</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>intervention group1: In the intervention group1 after breastfeeding 1gr Scrophularia striata cream will be rubbed to the nipple and areola 3 times a day for 7 days</i_keyword>
      <i_keyword>intervention group2: in the intervention group two after breastfeeding 1gr Lanolin cream will be rubbed to the nipple and areola 3 times a day for 7 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction of nipple pain. Timepoint: Before intervention, day 3 and day 8 after intervention. Method of measurement: Using Numerical Rating Scale for measuring pain intensity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The improvement of nipple fissures. Timepoint: Before intervention, day 3 and day 8 after intervention. Method of measurement: Measure the severity of damage, by store.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-27</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
