<?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>IRCT2013122215891N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-20</date_registration>
      <primary_sponsor>Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica</primary_sponsor>
      <public_title>hyperprolactinemia</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of marticaria chamomilla syrup and cabergoline on hyperprolactinemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>158</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15020</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hyperprolactinaemia.</hc_freetext>
      <i_freetext>Intervention 1: Medication administration ( marticaria chamomilla syrup)  5 cc two times a day for 4 weeks. Intervention 2: Cabergoline 0.25 mg twice a week.</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>Marya Kabiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behesht Ave., Vahdat eslami St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>009821:55601274</telephone>
        <email>m-kabiri@razi.tums.ac.ir, marya_kabiri@yahoo.om</email>
        <affiliation>Traditional Medicine Faculty, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farnaz Sohrabvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini Hospital, Keshavar Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2741</telephone>
        <email>fsohrabvand@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patient satisfaction; Female; Outpatients older than 18 years; Patient with asymptomatic or mild symptoms  idiopathic hyperprolactinemia (menstrual disorders that are just starting with or without galactorrhea or without bothering galactorrhea alone); Serum prolactin level above 25 μgr/L&#13;
   Exclusion criteria: Patients older than 45 years; Patient with liver failure; Patient with kidney failure; Patient with hypothyroidism; Taking medication such as haloperidol, phenothiazine, butyrophenone, monoamine oxidase inhibitor, fluoxetine, sulpiride, metoclopramide, domperidone, tricyclic antidepressants, opioid, estrogen, verapamil, reserpine, methyldopa, benzodiazepine, cimetidine, medroxolol drugs and any medication that is effective in prolactin secretion in the last three months; The use of warfarin; The use of sedating; Prolactinoma( micro or macro adenoma); Adrenal, pituitary and hypothalamus disease; Pregnant women; Women who plan to become pregnant;  Breast feeding; Autoimmune disease such as lupus; Long- term menstural disorders; Bothering galactorrhea; Underlying disease such as diabetes, hypertension and cancer; History of hyperprolactinemia treatment in the last 6 months; The use of propranolol and vasoconstrictor drugs; Raynaud’s disease; History sensitivity to ergot derivatives;  History of stomach ulcers and gastrointestinal bleeding; Asthma; History of hay fever and allergic reaction to member of the compositae family such as yarrow, feverfew, artemisia, tansy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E 22.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hyperprolactinaemia</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>Medication administration ( marticaria chamomilla syrup)  5 cc two times a day for 4 weeks.</i_keyword>
      <i_keyword>Cabergoline 0.25 mg twice a week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum prolactin level. Timepoint: Before and after the intervention. Method of measurement: Laboratory measurement.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: During the treatment. Method of measurement: questionnaire and Physical exam.</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>Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-09</approval_date>
        <contact_name>Ethics Committee, Faculty of Traditional Medicine, Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blv Ghods St Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
