<?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>IRCT20200530047600N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-18</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48541</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization
Unit: Individual
It is not stratified
Tools: random allocation statistical software
Regarding concealment: A person outside the design will prepare sealed envelopes based on the random allocation sequence created and provide them to the executors, Blinding description: The same capsules, with the same number, are placed in similar enveloped envelopes (from 1 to 80) based on a random assignment list by a person outside the research design.The study subjects receive the capsules monthly and in envelopes with the code. Participants, researchers, data evaluators, and data analysts are unaware of how the code is assigned.</study_design>
      <phase>3</phase>
      <hc_freetext>Premenstrual Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The test group received oral capsules containing Echium and fennel  at a dose of 2 grams of Echium and 1 gram of fennel fruit (Ground and granulated) during the day, three times a day with a glass of lukewarm water for the second two weeks of Cycle in two consecutive cycles. Intervention 2: Control group: The control group will receive a placebo capsule containing starch with the conditions of the intervention group.</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 اطلاعات بیشتری وجود ندارد</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Simin Sadat Motevalli Haghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177899191</zip>
        <telephone>+98 51 3891 0394</telephone>
        <email>motevalihs961@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Maliha Motusalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177899191</zip>
        <telephone>+98 51 3884 8930</telephone>
        <email>MotavasselianM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 35 years
Regular menstruation for the past 6 months,
Bleeding period 3 to 9 days and two bleeding intervals 24 to 35 days,
Complete the conscious consent form
Get a minimum score of 19 from the PSST questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension
Death of a loved one in the last six months
The use of anti-anxiety and anti-depressant drugs in the last three months,
The use of estrogen and progesterone medications in the last three months,
Taking herbal medicines and vitamin and mineral supplements over the past month,
History of allergy to Echium and fennel
Pregnancy and lactation</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 - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The test group received oral capsules containing Echium and fennel  at a dose of 2 grams of Echium and 1 gram of fennel fruit (Ground and granulated) during the day, three times a day with a glass of lukewarm water for the second two weeks of Cycle in two consecutive cycles.</i_keyword>
      <i_keyword>Control group: The control group will receive a placebo capsule containing starch with the conditions of the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of change in the severity of symptoms of premenstrual syndrome. Timepoint: Before the intervention, the first menstrual cycle after the intervention, the second menstrual cycle after the intervention. Method of measurement: Daily Record of Severity of Problems (DRSP).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The relationship between general temperament and the severity of symptoms. Timepoint: At the beginning of the study. Method of measurement: Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ).</sec_outcome>
      <sec_outcome>Changes in the quality of life in the intervention and control groups. Timepoint: Before and after the intervention. Method of measurement: Short-Form Health Survey questionnaire(SF-36).</sec_outcome>
      <sec_outcome>Possible side effects. Timepoint: During the intervention. Method of measurement: Patient report.</sec_outcome>
      <sec_outcome>The relationship between general temperament and the type of symptoms. Timepoint: At the beginning of the study. Method of measurement: Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ).</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>2020-05-23</approval_date>
        <contact_name>Ethics Committee in Research of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee in Research, Central University Building, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
