<?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>IRCT20200401046914N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-30</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Black seed and monstrogol and mefenamic acid on postpartum pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of nigella sativa and Menstrogol ® and Mefenamic acid on postpartum pain in women with after-pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57159</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation is done using three-membered blocks with a ratio of 1: 1: 1 with three members A = black seed capsule, B = monstrogel capsule C = mefenamic acid using block randomization method. To do this, first determine all possible combinations in the blocks (for example, "CBA, ABC, CAB) and then write them on the same pieces of paper and put them in a sealed envelope. The paper is randomly extracted and continues until the sample size is reached.The resulting sequence chain is used to assign participants to the groups, Blinding description: The capsule will be given to patients with a completely similar appearance and the form of the drugs will be the same. Therefore, the patient will not know the type of intervention. The data collector will not be aware of the type of intervention. The data analyst will not know the type of intervention. Therefore, the study will be conducted in a three-way blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>postpartum pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: One 500 mg capsule of Nigella sativa every 6 hours for 24 hours about 2 hours after delivery. Intervention 2: Intervention group: One 500 mg capsule of Menstrogol every 6 hours for 24 hours about 2 hours after delivery. Intervention 3: Control group: One 250 mg capsule of mefenamic acid every 6 hours for 24 hours about 2 hours 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>Nahid Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, Ghaffari St. Birjand City.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9716813448</zip>
        <telephone>+98 991 577 1494</telephone>
        <email>Navid.fp4m@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, Ghaffari St, Birjand City.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9716813448</zip>
        <telephone>+98 991 577 1494</telephone>
        <email>Navid.fp4m@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Literacy for reading and writing
Gestational age 37 to 42 weeks
Spontaneous exit of pairs and curtains
Having a moderate to severe back pain score
Having a healthy and single baby
Mother age 15-44 years
Spontaneous vaginal delivery
Iranian
Start and perform breastfeeding successfully
Satisfaction to participate in research</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having serious postpartum complications
Lack of breastfeeding due to maternal and neonatal causes
Smoking and drugs
Having a medical illness
Taking drugs during labor
Having 3rd and 4th degree rupture
Taking painkillers during the last 4 hours
Allergy to herbal medicines
use epidural and spinal anesthesia during labor
Having history of cesarean section and abdominal surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for maternal postpartum care and examination</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: One 500 mg capsule of Nigella sativa every 6 hours for 24 hours about 2 hours after delivery</i_keyword>
      <i_keyword>Intervention group: One 500 mg capsule of Menstrogol every 6 hours for 24 hours about 2 hours after delivery</i_keyword>
      <i_keyword>Control group: One 250 mg capsule of mefenamic acid every 6 hours for 24 hours about 2 hours after delivery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity postpartum after-pain. Timepoint: Before and one hour after the first intervention, before and one hour after the second intervention, before and one hour after the third intervention, before and one hour after the fourth intervention. Method of measurement: Numeric pain Rating scale.</prim_outcome>
      <prim_outcome>Postpartum hemorrhage. Timepoint: Before and after the intervention. Method of measurement: Higam bleeding measuring instrument.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-28</approval_date>
        <contact_name>committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences, Moalem Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
