<?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>IRCT20260609069717N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-22</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Elaeagnus angustifolia cream on hemorrhoids during pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Elaeagnus angustifolia cream on hemorrhoid symptoms in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/90733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to two groups using a randomized block design. The blockrand package will be employed through the website www.sealedenvelope.com. In the specified function, the number of treatment groups will be set to 2 and the block size to 4. The generated allocation sequence will be random with ablock size of four, and participants will be assigned to the intervention and control groups based on this sequence, Blinding description: This study is designed as a triple-blind randomized controlled trial. The researcher, participants, and statistician will be blinded to group allocation( intervention vs. control). An independent pharmacist( no involvement in sample allocation, intervention, or patient assessment) will be responsible for coding. Tubes containing the active cram and placebo will be labeled as A and B.The data provided to the statistician will be coded to ensure the group identity remains undisclosed.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemorrhoids in pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Eligible pregnant women with hemorrhoid symptoms, confirmed as grade 1 or 2 by a physician at the health center, will receive lifestyle modification education and will apply 3 g of 5% oleaster extract cream (prepared at the Pharmacological Research Center for Medicinal Plants, Mashhad University of Medical Sciences) topically every 12 hours for 2 weeks. Intervention 2: Control group:Eligible pregnant women with hemorrhoid symptoms, confirmed as grade 1 or 2 by a physician at the health center, will receive lifestyle modification education and will apply 3 g of the base cream (without extract, prepared at the Pharmacological Research Center for Medicinal Plants, Mashhad University of Medical Sciences) topically every 12 hours for 2 weeks.</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 No more information is available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Dehghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>DehghaniF4032@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboobeh Firoozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>firoozim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Able to read and write
Pregnancy women aged 18-45 years
Singleton pregnancy
Gestational age between14 and 34 weeks
Body mass index of less than 30
Willingness to participate in the study
Presence of grade 1 or 2 hemorrhoids</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Concurrent participation in another interventional study
History of hemorrhoid surgery in the last month
Presence of specific underlying diseases, obstetric complications, or other colorectal disorders
Allergy to Elaeagnus angustifolia
Use of anti-hemorrhoid drugs or systemic steroids during the two weeks before the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O22.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemorrhoids in pregnancy</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:Eligible pregnant women with hemorrhoid symptoms, confirmed as grade 1 or 2 by a physician at the health center, will receive lifestyle modification education and will apply 3 g of 5% oleaster extract cream (prepared at the Pharmacological Research Center for Medicinal Plants, Mashhad University of Medical Sciences) topically every 12 hours for 2 weeks.</i_keyword>
      <i_keyword>Control group:Eligible pregnant women with hemorrhoid symptoms, confirmed as grade 1 or 2 by a physician at the health center, will receive lifestyle modification education and will apply 3 g of the base cream (without extract, prepared at the Pharmacological Research Center for Medicinal Plants, Mashhad University of Medical Sciences) topically every 12 hours for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of hemorrhoid pain. Timepoint: Before the intervention, 1 week and 2 weeks after the start of the intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale.</prim_outcome>
      <prim_outcome>Severity of hemorrhoid swelling. Timepoint: Before the intervention, 1 week and 2 weeks after the start of the intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale.</prim_outcome>
      <prim_outcome>Severity of hemorrhoid bleeding. Timepoint: Before the intervention, 1 week and 2 weeks after the start of the intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale.</prim_outcome>
      <prim_outcome>Severity of hemorrhoid itching. Timepoint: Before the intervention, 1 week and 2 weeks after the start of the intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale.</prim_outcome>
      <prim_outcome>Severity of anal discomfort. Timepoint: Before the intervention, 1 week and 2 weeks after the start of the intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale.</prim_outcome>
      <prim_outcome>Negative impact score of hemorrhoids on well-being. Timepoint: Before the intervention, 1 week and 2 weeks after the start of the intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-03</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
