<?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>IRCT20180501039490N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-06</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of Centella Asiatica and Conjugated estrogen vaginal cream for the treatment of vaginal atrophy in postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of Centella Asiatica and Conjugated estrogen vaginal cream for the treatment of vaginal atrophy in postmenopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30888</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation will be done by typing on the code assigned to the Centella Asiatica cream and the conjugated estrogen cream. These codes are wrriten on two peaces of papers which are place in one box. At the first day of sampling, the researcher takes one of the papers inside the box , which will be assigned to the first sample,and the other code will be allocated to the next sample(control). In this way, subjects will be assigned to intervention and control group, Blinding description: Similarity of creams in terms of shape, color and size of cream-containing shells.</study_design>
      <phase>4</phase>
      <hc_freetext>Vaginal Atrophy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Centlla Asiatica Cream 1% , daily for 8 weeks as an applicator, produced in the laboratory of school of Pharmacy, Mashhad University of Medical Sciences, Mashhad,Iran. Intervention 2: Control group: Conjucated estrogen cream.</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 "No more information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Rahmanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.48,,Ladan 22 Blvd.,Vakil Abad Ave.,Mashad</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9179965789</zip>
        <telephone>+98 51 3891 5478</telephone>
        <email>Rahmanpourm951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>prof. Robab Latifnejad Roudsari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences,Mashhad,Iran</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91388-13944</zip>
        <telephone>+98 38413007051</telephone>
        <email>latifnejadr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being Iranian and residence of Mashhad,Iran
Married and Sexually active women
age range of 40–65 years
Having reading and writing skills
Having amenorrhea for at least 12 months , or 6 months amenorrhea  with FSH&gt;40 or an endometrial thickness of 5 mm or less as determined by transvaginal ultrasonography
Getting a score of ≥ 65 on the visual analogue scale (VAS) and having at least one symptom  of physical examination scale and a vaginal pH value &gt; 5 and Vaginal maturation index(VMV) &lt; 50</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Current or suspected endometrial cancer
Suspected genital cancer
Reproductive system abnormalities
Genital bleeding with unknown causes
Use of anti hypertensive drugs
Smoking or passing at least 3 months after smoking ceasation
Vaginal infections
Use of hormone replacement therapy 8 weeks before the study
Use of foods containing 40 to 60 grams (about one tbsp) of phyto estrogen (such as red clover, flaxseeds and soy beans) in the past month
Having conditions such as diabetes, chronic renal disease, arthritis, cardiovascular diseases, and active disease in the liver or gallbladder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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 group: Centlla Asiatica Cream 1% , daily for 8 weeks as an applicator, produced in the laboratory of school of Pharmacy, Mashhad University of Medical Sciences, Mashhad,Iran</i_keyword>
      <i_keyword>Control group: Conjucated estrogen cream</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vaginal pH. Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Merk PH-indicator strips.</prim_outcome>
      <prim_outcome>Vaginal maturation value (VMV). Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Pathological examination.</prim_outcome>
      <prim_outcome>Vaginal maturation index (VMI). Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Pathological examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Most bothersome symptom(MBS). Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Vaginal physical examination. Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: physical examination scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-21</approval_date>
        <contact_name>The Research Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave, Mashhad,Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
