<?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>IRCT20210502051161N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-22</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of Domask Rose essence and citrus aurantium on premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of Domask Rose essence and citrus aurantium on the severity of the symptoms of premenstrual syndrome in the students of Jahrom University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/83332</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method in this study was simple random allocation, in which, based on the list of female students in the operating room, anesthsia, and nursing, using a random number table, the first and second selected numbers from the students class list were placed in the test group, and the third number was placed in the control group in the same way. Allocation of samples in three groups continued until the number of samples was complete, Blinding description: The students in the experimental and control groups will be placed in two separate locations. In the first experimental group, a bottle containing 15 cc of 40% Domask Rose essence, from Barij Essential Oil Company, Kashan, will be provided to the experimental group. In the second experimental group, a bottle containing 15 cc of Citrus Aurantium essence, from Barij Essential Oil Company, Kashan, will be provided to the experimental group. For the students in the control group, a bottle containing 15 cc of edible Sweet Almond oil will be provided to them.The bottles containing essence oDomask Rose, Citrus Aurantium, and edible sweet almond are the same shape and none will have a specification label and will be marked with labels A (Domask Rose essence), B (Citrus Aurantium essence), and C (Sweet Almond oil) to differentiate them. Then, all three groups will be given bottle A, bottle B, and the control group will be given bottle C, respectively. Sufficient information will be given to the groups on how to consume the contents of the bottles.In this way, during two menstrual cycles, from 7 days before menstruation to the third day of menstruation, they will measure and drink 5 drops of the contents of the desired bottle by the bottle's own mouthpiece. At the end of each menstrual cycle during the intervention period, they will be asked to complete a premenstrual symptoms screening questionnaire.</study_design>
      <phase>3</phase>
      <hc_freetext>Premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aromatherapy is performed by individuals 1 week before menstruation until the third day of menstruation, twice a day for 5 minutes each time for 2 consecutive cycles, in a quiet place and in a stable and comfortable position, and they take 5 drops of the contents of the bottle with a dropper. For the first group, the dose of Domask rose essence used is 4% and for the second group, citrus aurantium essence is 0.5%. Intervention 2: Control group: Aromatherapy is performed by individuals 1 week before menstruation until the third day of menstruation, twice a day for 5 minutes each time for 2 consecutive cycles, in a quiet place and in a stable and comfortable position, and they take 5 drops of the contents of the bottle with a dropper. Sweet almond oil is used for this 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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Reza Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Motahari Street, Jahrom University of Medical Sciences, Campus Site</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 74 1484 6199</telephone>
        <email>Hamidrezaa891425@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahareh Mahdood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Motahari Street, Jahrom University of Medical Sciences</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 0405</telephone>
        <email>baharehmahdood68@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Completing the informed consent form
Having premenstrual syndrome based on self-report and questionnaire
Not taking hormonal medications for at least two months before the study
No use of any medication to reduce symptoms during menstruation or use of a specific medication such as painkillers by all participants
Not taking vitamin supplements one month before the start of the intervention
Absence of underlying physical and mental disorders based on the Goldberg General Health Scale
Having regular menstruation
Student dormitory resident</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue participating in the study
The occurrence of stressful events during the study and the use of any other medication during the study
Changes in menstrual cycle intervals and duration based on criteria
Sensitivity to essences used in the study
Incomplete completion of questionnaires</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Aromatherapy is performed by individuals 1 week before menstruation until the third day of menstruation, twice a day for 5 minutes each time for 2 consecutive cycles, in a quiet place and in a stable and comfortable position, and they take 5 drops of the contents of the bottle with a dropper. For the first group, the dose of Domask rose essence used is 4% and for the second group, citrus aurantium essence is 0.5%.</i_keyword>
      <i_keyword>Control group: Aromatherapy is performed by individuals 1 week before menstruation until the third day of menstruation, twice a day for 5 minutes each time for 2 consecutive cycles, in a quiet place and in a stable and comfortable position, and they take 5 drops of the contents of the bottle with a dropper. Sweet almond oil is used for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Screening for premenstrual symptoms. Timepoint: Before and after menstruation. Method of measurement: PSST questionnaire.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-03</approval_date>
        <contact_name>Ethics Committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Ostad Motahari Boulevard Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
