<?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>IRCT20240109060656N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-08</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>herbal medicine myrrh , sesamum indicum and oral contraceptive pill  for treatment of incomplete abortion</public_title>
      <acronym></acronym>
      <scientific_title>comparison between herbal medicine myrrh , sesamum indicum and oral contraceptive pills for treatment of incomplete abortion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74925</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study includes 160 patients in 4 groups. 160 patients were divided into 40 blocks of 4. Each block is numbered and will be used for 4 patients, that is, if block number 2 is selected in the lottery, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment C, and the fourth patient will receive treatment D. The fifth patient will be randomly selected from one of the blocks and the type of treatment will be assigned to the fifth to eighth patients according to the block, Blinding description: The study was conducted in a double-blind manner, and the patients and the examiner of the results (our expert radiologist) will not be aware of the type of drug used. Each drug is placed in a box in the package with a corresponding number label so that the patient does not have any information about the type of drug used. The shape and packaging of myrrh and OCP capsules and sesame and placebo are similar. In this study, our nurse colleague in the hospital affiliated to Shiraz University of Medical Sciences will deliver medicine and placebo to the study participants based on the random block table.</study_design>
      <phase>1-2</phase>
      <hc_freetext>incomplete abortion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In group A, LD, which is a type of OCP tablet that is placed inside the capsule with Avacil and is prepared as a capsule. This capsule is prescribed for 40 patients for 14 days. Intervention 2: Intervention group: Group B Myrrhs capsules to 40 patients, 500 mg BID for 14 days. Intervention 3: Intervention group: Group C (n=40),Contact capsules with dried sesame extract are given to 40 patients for 14 days (BID). Intervention 4: 40 patients will receive a placebo capsule (containing Avacil) for 14 days.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data related to the study will not be published

When:
Data related to the study will not be published

To whom:
Data related to the study will not be published

Conditions:
Data related to the study will not be published

Where to obtain:
Data related to the study will not be published

How to obtain:
Data related to the study will not be published

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Rowshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>f.rowshani@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Rowshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>f.rowshani@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>healthy women with a normal blood count ( hemoglobin &gt; ۹)
estimated gestational age less than ۲۰ weeks
with intrauterine tissue with an anterior posterior diameter ۱۵-۵۰ mm less than ۱ month post abortion
BMI ≤ ۳۰
no fever
no pelvic tenderness
no infection in vaginal exam
Age between 18 and 35 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Age less than 18 and more than 35 years
BMI&gt;30
Presence of infection in vaginal examination</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O03. 4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous abortion Incomplete, without complication.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In group A, LD, which is a type of OCP tablet that is placed inside the capsule with Avacil and is prepared as a capsule. This capsule is prescribed for 40 patients for 14 days</i_keyword>
      <i_keyword>Intervention group: Group B Myrrhs capsules to 40 patients, 500 mg BID for 14 days</i_keyword>
      <i_keyword>Intervention group: Group C (n=40),Contact capsules with dried sesame extract are given to 40 patients for 14 days (BID).</i_keyword>
      <i_keyword>40 patients will receive a placebo capsule (containing Avacil) for 14 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Remaining remnants of the placenta after abortion. Timepoint: After the end of 14 days of treatment. Method of measurement: Using the findings observed in transvaginal color doppler ultrasound.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-24</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
