<?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>IRCT2015042421915N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-28</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Purslane Cream on the Breast Fissure</public_title>
      <acronym></acronym>
      <scientific_title>effects of Purslane Cream on the BreastFissure in Lactating Women: A Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19054</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, multi-stage sampling was performed. In the first stage, sampling was done
in a class. The classes are the five regions of health centers (1-5) of Mashhad, Iran. They were
randomly selected from two classes (center number 3 and 5). The second phase of sampling
was randomly carried out according to the ratio of the patients referred to the thyroid clinic of
centers 3 and 5. In the third stage, among the lactating women referring to these 4 thyroid clinic
centers, firstly, the units of study were selected by inclusion criteria and then placed in two
groups of lanolin and purslane creams on the basis of random numbers. Noteworthy, mothers
along with their children should be routinely visited by their health centers on the third to fifth
day after childbirth to screen and prevent the hypothyroidism and related disorders. In this
regard, these centers were selected to provide more access to lactating women during this
period. Following the selection, required explanations regarding the research design, the
method of research, how to use drugs and the probability of drug allergy were given to them. If
they wished to participate in the research, written consent was obtained in order to observe the
ethical issues, they were assured about the confidentiality of their information and they can
leave the study at any time desired. Using the number cruncher statistical system (NCSS)
software, the samples were randomly assigned to one of the two groups of lanolin and purslane
cream, Blinding description: Drugs were packed by the pharmacist who un-known regarding the process of the study, in the
same tubes of 30 grams and was coded (A and B).</study_design>
      <phase>3</phase>
      <hc_freetext>Nipple fissure.</hc_freetext>
      <i_freetext>In the intervention group after breastfeeding 1gr purslane cream will be rubbed to the nipple and areola 3 times a day for8 days.control group  after breastfeeding 1grlanolin cream will be rubbed to the nipple and areola 3 times a day for8 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Promising effects of Purslane Cream on the Breast Fissure in
Lactating Women: A Clinical Trial

When:
2018

To whom:
student midwife

Conditions:
systematic review

Where to obtain:
azin_niazi65@yahoo.com

How to obtain:
Articles published in this field will be sent to the applicant.

Comments:
.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azin Niazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing And Midwifery</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6818714818</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>niazia931@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Yousefzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fourway Doctoral Faculty، of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6818714818</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>yousefzadehs@mums.ac.ir</email>
        <affiliation>Mashhad Univercity of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. Moreover, other exclusion criteria were abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day, and mother's use ofcold or hot compresses</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group after breastfeeding 1gr purslane cream will be rubbed to the nipple and areola 3 times a day for8 days.control group  after breastfeeding 1grlanolin cream will be rubbed to the nipple and areola 3 times a day for8 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breast Fissure. Timepoint: Before intervention, day 3 and day 8 after intervention. Method of measurement: Using  Stour scale.</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>Vice Chancellor for Research and Technology Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-18</approval_date>
        <contact_name>Vice Chancellor for research of Mashhad University of medical sciences</contact_name>
        <contact_address>Mashhad ، Ghoreshi Building ، Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
