<?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>IRCT20201027049164N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-16</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparative investigation between the effectiveness of Achillea wilhelmsii tablet and group counseling based on acceptance and commitment on Pre Menstrual Syndrome (PMS) symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Comparative investigation between the effectiveness of Achillea wilhelmsii tablet and group counseling based on acceptance and commitment on Pre Menstrual Syndrome (PMS) symptoms in students living in the dormitories</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>264</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58045</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For simple randomization, the numbers 1 to 135 are assigned to the participants, respectively. Then, using online software to generate random sequences (www.randomizer.org), they will be divided into three groups of 45 will be placed in the counseling group and the yarrow and control receiving group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstrual Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: The counseling group will receive 8 sessions of 90-minute counseling based on acceptance and commitment once a week. Intervention 2: Intervention group2: The yarrow group is given yarrow pills at variable doses that follow the estrogen pattern of the menstrual cycle. Thus, at first, the estrogen menstrual cycle is low, and then, like the normal menstrual cycle, when estrogen levels gradually increase, the dose of yarrow pills increases. The maximum dose of the pill is given on the fourteenth day according to the peak estrogen in the normal cycle. Then, as in the normal cycle, when the amount of estrogen decreases, the dose of yarrow tablets decreases, ie the dose of the drug starts from 70 mg, twice a day, and until the fourteenth day, we add 10 mg every day, and on the fourteenth day the maximum dose is 200 mg. We will have 14 days. Intervention 3: Control group: They do not receive any intervention.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The release schedule is not yet known</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra pakdel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5856</telephone>
        <email>zahrapakdel75@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Ghazanfarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5856</telephone>
        <email>M.ghazanfarpour@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All samples should have a menstrual cycle duration of 35-24 days.
Being single
The age of the samples should be between 18-45 years.
Samples with premenstrual syndrome for at least six months and tend to participate in the study.
Do not have any mental or physical illness.
Do not take any chemical and herbal medicines
Do not take birth control pills
Have at least one symptom of mental and physical symptoms that should begin 16 days after menstruation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Menstrual period is less than 3 days and more than 8 days
Interval of menstrual cycles less than 24 days and more than 35 days
Existence of severe stress in the last trimester such as: death of relatives, marriage or surgery
Pregnant and lactating women
Participating in a simultaneous counseling program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premenstrual tension syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: The counseling group will receive 8 sessions of 90-minute counseling based on acceptance and commitment once a week.</i_keyword>
      <i_keyword>Intervention group2: The yarrow group is given yarrow pills at variable doses that follow the estrogen pattern of the menstrual cycle. Thus, at first, the estrogen menstrual cycle is low, and then, like the normal menstrual cycle, when estrogen levels gradually increase, the dose of yarrow pills increases. The maximum dose of the pill is given on the fourteenth day according to the peak estrogen in the normal cycle. Then, as in the normal cycle, when the amount of estrogen decreases, the dose of yarrow tablets decreases, ie the dose of the drug starts from 70 mg, twice a day, and until the fourteenth day, we add 10 mg every day, and on the fourteenth day the maximum dose is 200 mg. We will have 14 days</i_keyword>
      <i_keyword>Control group: They do not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of premenstrual syndrome. Timepoint: Beginning of the study (before the start of the intervention) and end of the intervention. Method of measurement: Daily Symptom Report Questionnaire (DSR).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-10</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology;ebne-e-Sina St.,Jahad Blvd., Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
