<?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>IRCT2016073029126N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-30</date_registration>
      <primary_sponsor>Vice chancellor for research, Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Achillea Millefolium on heavy menstrual bleeding</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of Comparing the effect of Achillea Millefolium capsules and Mefenamic Acid  on the amount and duration of menstrual bleeding in women affected by menorrhagia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23488</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study has been done by triple blind method. To do this, patients, researcher and statistical consultant were not aware of prescribed drug's nature. 90 women using Excel software, were randomly allocated to Achillea Millefolium  or control groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Menorrhagia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:   In control group, Mefenamic acid capsule 500 mg every 8 hours and placebo capsules 500 mg per day  every 12 hours,  were prescribed from the first day to the end of bleeding up to seven days. Intervention 2: Intervention 2:   In Achillea Millefolium group, Mefenamic acid capsules, 500 mg every 8 hours and hydro alcoholic extract of Achillea Millefolium capsules, 500 mg per day every 12 hours,were prescribed, from the first day to the end of bleeding up to 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>Katayoun Vakilian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beside Amir almomenin hospital, Sardasht St, Basij Sq, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3524</telephone>
        <email>Dr.vakilian@arakmu.ac.ir</email>
        <affiliation>School of Nursing and Midwifery Of Arak</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasim Khaademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University,Najafabad,Esfahan</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 4229 2530</telephone>
        <email>Khademi_nasim@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Affected by menorrhagia, Regular menstrual cycles,Body mass index between18.5- 29.5,Age between 18-45 years,No history of known systemic or pelvic inflammatory diseases, Not pregnant, No consumption of specific medications,No abnormal pap smear or ultrasonography,  No history of sensitivity to medicinal plants.&#13;
Exclusion criteria: Pregnancy during the study, Failure to adhere to prescribed treatment, sensitivity to the study medications, Unwilling to continue participation in the study,Occurrence a specific disease,Taking any herbal or chemical drug during the study,Occurrence of a specific event during the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N92-0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>excessive and frequent menturation with regular cycle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1:   In control group, Mefenamic acid capsule 500 mg every 8 hours and placebo capsules 500 mg per day  every 12 hours,  were prescribed from the first day to the end of bleeding up to seven days.</i_keyword>
      <i_keyword>Intervention 2:   In Achillea Millefolium group, Mefenamic acid capsules, 500 mg every 8 hours and hydro alcoholic extract of Achillea Millefolium capsules, 500 mg per day every 12 hours,were prescribed, from the first day to the end of bleeding up to seven days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of bleeding. Timepoint: before treatment، First month during treatment, second month during treatment. Method of measurement: Higam Chart.</prim_outcome>
      <prim_outcome>Duration of bleeding. Timepoint: before treatment، First month during treatment, second month during treatment. Method of measurement: Higam Chart.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of medication. Timepoint: 2 months after treatment. Method of measurement: Questionnaire.</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, Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-07</approval_date>
        <contact_name>Ethics committee of Arak of University of Medical Sciences</contact_name>
        <contact_address>Beside Amir almomenin hospital, Sardasht St, Basij Sq,Arak Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
