<?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>IRCT20191231045965N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-08</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effects of silymarin and N-acetylcysteine on improvement of, Hepatic and renal Abnormalities in Patients with SeverePreeclampsia in post-partum</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effects of silymarin and N-acetylcysteine on improvement of, Hepatic and renal Abnormalities in Patients with SeverePreeclampsia in post-partum</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45002</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, our patient cohorts are characterized by the size of the sample set.Then they are randomized by simple randomization using randomization software and generating randomized codes to assign each patient to each of the groups under study.The code generated by the software is specified by the sample size of each group and which code the disease belongs to the researcher.Patients were included in the initial cohort, Blinding description: Both medicines are packaged in the same package and given to the resident and she will provide the medication at the prescribed time.</study_design>
      <phase>2</phase>
      <hc_freetext>Preeclampcia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 70 mg silymarin is given  immediately after delivery and 12 hours and 24 hours after delivery. Intervention 2: Intervention group: 600 mg of N-acetylcysteine is given immediately after delivery, 12 hours and 24 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 I will decide until the end of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Mahmoodnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursery Street, Hajar Hospital</address>
        <city>Shahre-kord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813833435</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>leilamahmoodnia@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Mahmoodnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursery Street, Hajar Hospital</address>
        <city>Shahre-kord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813833435</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>leilamahmoodnia@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Maternal age is between 20 and 30 years.
mothers BMI is between 20 and 24.
Gestational age at termination of pregnancy is between 35 and 42 weeks.
The patient's blood pressure should be greater than 140/90 mmHg before termination of pregnancy.
Proteinuria, in urine random sample before pregnancy termination.
Lack of history of hypertension, diabetes, kidney disease, collagen vascular disease and other cardiovascular diseases.
The mother is nulipar and has no previous abortion or pregnancy.
No history of smoking or alcohol in the mother.
Pregnancy is single and not molar.
Indication of termination of pregnancy in a patient with severe preeclampsia.
The patient has complete consent to participate in the study and has signed the consent form.
No incidence of eclampsia prior to inclusion.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patient dissatisfaction to participate in the study
Patient with eclampsia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O14.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe pre-eclampsia</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: 70 mg silymarin is given  immediately after delivery and 12 hours and 24 hours after delivery.</i_keyword>
      <i_keyword>Intervention group: 600 mg of N-acetylcysteine is given immediately after delivery, 12 hours and 24 hours after delivery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver enzymes. Timepoint: 0,12,36 and 60 hours after intervention. Method of measurement: labratoary kit.</prim_outcome>
      <prim_outcome>Platlet count. Timepoint: 0,12,36 and 60 hours after intervention. Method of measurement: count in mm3.</prim_outcome>
      <prim_outcome>Proteinuria. Timepoint: 0,12,36 and 60 hours after intervention. Method of measurement: labratoary kit.</prim_outcome>
      <prim_outcome>Urea. Timepoint: 0,12,36 and 60 hours after intervention. Method of measurement: mg per dl.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: 0,12,36 and 60 hours after intervention. Method of measurement: mg per dl.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: q 3 hours in study. Method of measurement: mmHg.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of blood pressure crisis in study. Timepoint: q 3 hours. Method of measurement: bp &gt;160/110 mmhg.</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>Shahre-kord university of medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-05</approval_date>
        <contact_name>•Ethics committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>No. 1,Godal cheshme Ave.,Gode pahlevanan Ave., Ayat Blvd., Shahrekord town Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
