<?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>IRCT20100130003226N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-22</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of capsule containing Pelargonium graveolens (Geranium) on postpartum blues</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of capsule containing Pelargonium graveolens (Geranium) on postpartum blues in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91631</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: It is available (simple) and goal based. In this way, all primiparous mothers who meet the conditions for entry into the study will be examined. Randomization will be done using Excel software; the list of random numbers will be the total number of samples, which will be recorded in front of each capsule code number A or B. Before the start of the study, the capsules will be placed in similar envelopes by the pharmacist consultant and the code A or B will be recorded on each envelope. 30 capsules will be placed in each envelope, and after the start of the study, based on the list of random numbers and the specified group in the order of entry into the study, the envelopes of capsules will be provided by the researcher to the research units, Blinding description: Geranium capsules and placebo are coded by the pharmacist; Researchers, research units and statistical analysts will be unaware of their content.</study_design>
      <phase>3</phase>
      <hc_freetext>Postpartum blues.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers who refer to health centers for first postpartum care within 3 to 5 days after delivery will be prescribed the intervention capsule twice a day for 14 days and the Stein questionnaire will be completed before the intervention and on days 10 and 14 after delivery. Intervention 2: Control group: Mothers who refer to health centers for first postpartum care within 3 to 5 days after delivery will be prescribed the placebo capsule twice a day for 14 days and the Stein questionnaire will be completed before the intervention and on days 10 and 14 after delivery.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mahrokh Dolatian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Gynecology Department ,In front of Shahid Rajaee Heart Hospital, The intersection of Niayesh, Vali Asr street, Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>009888655366</telephone>
        <email>mhdolatian@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahrokh Dolatian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Gynecology Department ,In front of Shahid Rajaee Heart Hospital, The intersection of Niayesh, Vali Asr street, Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>mhdolatian@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being Primiparous woman.
Aged 18 to 35 years.
Being literate in reading and writing.
Being Iranian.
Gestational age between 37 to 42 weeks.
Having alive and single  fetus.
Fetal weight between 2500 and 4000 gr.
Live with her husband and her husband has no other wife.
Do not have a history of mental disorders or severe stress.
Do not use chemical medications (antidepressants, sedatives or sleeping pills such as fluoxetine, sertraline) at the same time.
No smoking, alcohol and drugs.
No history of two or more miscarriages.
Do not suffer from adverse pregnancy and delivery outcomes including premature birth, instrumental delivery, birth of a baby with congenital abnormalities, preeclampsia, eclampsia, postpartum hemorrhage, infection, and breast problems.
No history of experiencing unfortunate and stressful events (serious illness of herself or her spouse and child, death of a loved one, accident, severe family conflict, divorce, immigration, dismissal or unemployment of herself or her spouse, and bankruptcy).
Having symptoms of postpartum blues. (According to the Stein questionnaire and obtaining a score higher than 8)
No history of allergy to herbal medicines, according to the individual's statement.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother or baby may need to be hospitalized.
Allergy to Geranium capsules.
The individual may not be willing to participate in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O90.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postpartum mood disturbance</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: Mothers who refer to health centers for first postpartum care within 3 to 5 days after delivery will be prescribed the intervention capsule twice a day for 14 days and the Stein questionnaire will be completed before the intervention and on days 10 and 14 after delivery.</i_keyword>
      <i_keyword>Control group: Mothers who refer to health centers for first postpartum care within 3 to 5 days after delivery will be prescribed the placebo capsule twice a day for 14 days and the Stein questionnaire will be completed before the intervention and on days 10 and 14 after delivery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum blues. Timepoint: Before intervention (days 3-5 after delivery), days 10 and 14 after delivery. Method of measurement: Stein questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of the drug. Timepoint: 14th after delivery. Method of measurement: Drug side effects 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>Shahid Beheshti University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-20</approval_date>
        <contact_name>Research Ethics Committees of School of Pharmacy and Nursing &amp; Midwifery- Shahid Beheshti University</contact_name>
        <contact_address>School of Nursing and Gynecology Department ,In front of Shahid Rajaee Heart Hospital, The intersection of Niayesh, Vali Asr street, Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
