<?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>IRCT2016110827998N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-11</date_registration>
      <primary_sponsor>Vice Chancellor for research of ShahreKord  University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of Aloe Vera gel and Sweet Almond oil on Striae Gravidarum in nulliparous women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Aloe Vera gel and Sweet Almond oil on Striae Gravidarum in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>steria gravidarum.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 : Will be given 700 g combination of aloe Vera (extracted from aloe Vera leaves) in a cream base and in a 1 to 1 ratio to rub 2g every 12 hours gently and without massage on the abdominal skin from the 16th week of pregnancy until the delivery day. The amount of cream will be calculated based on the Finger Tip Unit (FTU) (26). Intervention 2: Intervention group 2 : Each subject will be given 700 g combination of sweet almond oil in a cream base to rub 2g every 12 hours gently and without massage on all abdominal area from the 16th week of pregnancy until the delivery day.  The amount of cream will be calculated based on the Finger Tip Unit (FTU) (26). Intervention 3: Control group 1 :They will only be given 700g base cream to rub 2g every 12 hours gently and without massage on all abdominal area from the 16th week of pregnancy until the delivery day. Intervention 4: Control group 2 : They will be received no medication to treat or prevent striae.</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>Maryam Hajhashemy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahari avenue, Felezi bridge, Beheshti hospital, Esfahan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3776 6578</telephone>
        <email>hajhashemy73@yahoo.com</email>
        <affiliation>Shehrekord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Hajhashemy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid beheshti hospital, Motahary avenue, Felesy bridje, Esfahan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3776 6578</telephone>
        <email>hajhashemy73@yahoo.com</email>
        <affiliation>Shahrekord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 20 to 35 years old nulliparous women with normal body mass index (18.5 to 26); informed consent for participation in the study; using no topical medication for the treatment or prevention of striae before entering the study; and having no skin diseases.&#13;
Exclusion criteria: twin pregnancy; Polyhydramnios; preterm labor; the subject’s unwillingness to participate in the study; early termination of the cream; below 2 kg or above 4 kg infant birth weight; and using creams other than one prescribed for the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>026.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified pregnancy-related conditions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 : Will be given 700 g combination of aloe Vera (extracted from aloe Vera leaves) in a cream base and in a 1 to 1 ratio to rub 2g every 12 hours gently and without massage on the abdominal skin from the 16th week of pregnancy until the delivery day. The amount of cream will be calculated based on the Finger Tip Unit (FTU) (26).</i_keyword>
      <i_keyword>Intervention group 2 : Each subject will be given 700 g combination of sweet almond oil in a cream base to rub 2g every 12 hours gently and without massage on all abdominal area from the 16th week of pregnancy until the delivery day.  The amount of cream will be calculated based on the Finger Tip Unit (FTU) (26).</i_keyword>
      <i_keyword>Control group 1 :They will only be given 700g base cream to rub 2g every 12 hours gently and without massage on all abdominal area from the 16th week of pregnancy until the delivery day.</i_keyword>
      <i_keyword>Control group 2 : They will be received no medication to treat or prevent striae.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of abdominal areas affected by striae ,. Timepoint: during a six months period and in monthly. Method of measurement: the number of abdominal areas affected by striae (abdomen division into four zones) was measured by the examiner based on counting the number of areas.</prim_outcome>
      <prim_outcome>Number of striae. Timepoint: during a six months period and in monthly. Method of measurement: the number of striae was measured based on the observer’s observations.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Itching. Timepoint: during a six months period and in monthly. Method of measurement: itching (qualitative measure: low, medium, high) based on the subject’s expression.</sec_outcome>
      <sec_outcome>Striae diameter ,. Timepoint: during a six months period and in monthly. Method of measurement: by calipers.</sec_outcome>
      <sec_outcome>Erythema. Timepoint: during a six months period and in monthly. Method of measurement: qualitative measure: low, medium, high) by the observer’s observation.</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 of ShahreKord  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-08-07</approval_date>
        <contact_name>Vice Chancellor for research of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Billding number 2, university complex, Edarat avenue, Shahrekord Shahrekord  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
