<?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>IRCT2015080723535N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-24</date_registration>
      <primary_sponsor>research and technology department of Shahid Beheshti University of Medical Sciences, Tehran</primary_sponsor>
      <public_title>the effect of Pistacia Atlantica ointment on nipple pain intensity and improvement of nipple fissure</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Pistacia Atlantica ointment on nipple pain intensity and improvement of nipple fissure among visited breast feeding women in health centers of Shahid Beheshti university of Sciences in 1394</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20048</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>nipple fissure.</hc_freetext>
      <i_freetext>Intervention 1: 1 gram of  Pistacia Atlantica ointment (in 24 gram cans) will be rubbed  to the nipple and areola three times a day for 7 days. Intervention 2: In the control group 2-3 drops of  expressed breast milk will be rubbed to the nipple and areola after each feeding and then allow to air dry for seven 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nayereh Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Shahid Chamran Highway  Yemen street , A'rabi Street, near Shahid Ayatollah Taleghani hospital,Shahid Beheshti University of Medical Sciences, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۸۳۵۱۱۹</zip>
        <telephone>+98 21 23871</telephone>
        <email>asadi_ nayereh@sbmu.ac.ir   nayereh.asadi62@gmail.com</email>
        <affiliation>Shahid Beheshti University of Sciences, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nourossadat Kariman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'rabi street, near Shahid Ayatollah Taleghani hospital, Yemen street, Shahid Chamran highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۸۳۵۱۱۹</zip>
        <telephone>+98 21 23871</telephone>
        <email>n_kariman@sbmu.ac.ir        n_kariman@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Sciences, Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criteria: Mothers suffering from nipple pain and nipple fissure who; get at least grade 3 through Storr scale; more than 18 years old; Iranian and live in Tehran; literate; singleton birth; term and healthy infant and exclusively breast fed; infant weight 2500 to 4000 grams; infant without any mouth or palate or jaw or face anomaly; mother without any identified mental disease;  mother without any nipple malformation (flat or inverted nipples or any nipple malformation which is followed by burning or any history of nipple and areola operation in childhood); mothers don't suffer from known background diseases such as diabetes or any kind of internal_surgical diseases; mothers who do not have any allergy to Pistacia Atlantica ointment.  &#13;
Excluding Criteria: During the study, the infant uses a pacifier or feeding bottle;The mother makes use of milking machine or plastic nipple; During the study, the infant gets infected to a disease; During the study, allergy to Pistacia Atlantica occurs; During the study the mother uses antibiotic;The mother gets infected to mastitis, breast abscesses or fungal infection of the breast; The mother does not desire to continue cooperation; Use of the proposed treatment less than three times a day; Use of the other treatments by the mother.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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 - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1 gram of  Pistacia Atlantica ointment (in 24 gram cans) will be rubbed  to the nipple and areola three times a day for 7 days.</i_keyword>
      <i_keyword>In the control group 2-3 drops of  expressed breast milk will be rubbed to the nipple and areola after each feeding and then allow to air dry for seven days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction of nipple pain. Timepoint: before intervention, day 3 and day 7 after intervention. Method of measurement: using Numerical Rating Scale for measuring pain intensity.</prim_outcome>
      <prim_outcome>Improvement of nipple fissure. Timepoint: before intervention, day 3 and day 7 after intervention. Method of measurement: Storr scale to measure nipple fissure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of Pistacia Atlantica ointment. Timepoint: before intervention, day 3 and day 7 after intervention. Method of measurement: examining and interviewing the patient.</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>research and technology department of Shahid Beheshti University of Medical Sciences, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-21</approval_date>
        <contact_name>Institutional Ethics Committee of the Faculty of Pharmacy and Nursing Midwifery of Shahid Beheshti U</contact_name>
        <contact_address>Vali-Asr Avenue, Cross of Vali-Asr and Niayesh Highway, opposite to Rajaee Heart Hospital, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
