<?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>IRCT201012042085N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-01-20</date_registration>
      <primary_sponsor>Shahrekord University Of Medical Sciences</primary_sponsor>
      <public_title>Survey of Alhagi pseudalhagi effect on blood bilirubin in neonates with hyperbilirubinemia in Shahrekord Hajar hospital</public_title>
      <acronym></acronym>
      <scientific_title>Survey of Alhagi pseudalhagi effect on blood bilirubin in neonates with hyperbilirubinemia in Shahrekord Hajar hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1704</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hyperbilirubinemia.</hc_freetext>
      <i_freetext>Intervention 1: The mother and neonate received Alhagi pseudalhagi 25% cocentration solution, 30 cc and 1cc/kg, respectively, every 8 hours as well as phototherapy until the serum level of bilirubin decreased to the normal level. Intervention 2: The mother only received Alhagi pseudalhagi 25% cocentration solution, 30 cc every 8 hours as well as phototherapy for the neonates until the serum level of bilirubin decreased to the normal level. Intervention 3: In the control group, neither mother nor neonate received the solution. The neonates only received phototherapy until the serum level of bilirubin decreased to the normal level. Intervention 4: The neonate only received Alhagi pseudalhagi 25% cocentration solution, 1 cc/kg, every 8 hours as well as phototherapy until the serum level of bilirubin decreased to the normal level.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Parvin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University Of Medical Sciences</address>
        <city>Shahrekord University Of Medical Sciences</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 38 1334 6692</telephone>
        <email>np285@yahoo.com</email>
        <affiliation>Shahrekord University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Signing informed consent by parents, total serum bilirubin between 14 and 20 mg/dL, presence of Non hemolytic hyperbilirubinemia, presence of indirect hyperbilirubinemia, hyperbilirubinemia which starts between the third and tenth days after birth, term infant, (Gestational age 42-37 weeks), birth weight 4-5/2 Kg, exclusive breast feeding, Ability of mother to attend the neonate’s bedside, no congenital anomaly, no sepsis, history of asphyxia, or traumatic delivery, no cephalohematoma, no history of neonatal jaundice, no previous treatment for jaundice, any other treatments or hospitalization, no other treatment with antibiotic or other drugs&#13;
Exclusion criteria: discharge for any reason before bilirubin less than 12mg/dl, need to other drugs during treatment</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice from other and unspecified causes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The mother and neonate received Alhagi pseudalhagi 25% cocentration solution, 30 cc and 1cc/kg, respectively, every 8 hours as well as phototherapy until the serum level of bilirubin decreased to the normal level.</i_keyword>
      <i_keyword>The mother only received Alhagi pseudalhagi 25% cocentration solution, 30 cc every 8 hours as well as phototherapy for the neonates until the serum level of bilirubin decreased to the normal level.</i_keyword>
      <i_keyword>In the control group, neither mother nor neonate received the solution. The neonates only received phototherapy until the serum level of bilirubin decreased to the normal level.</i_keyword>
      <i_keyword>The neonate only received Alhagi pseudalhagi 25% cocentration solution, 1 cc/kg, every 8 hours as well as phototherapy until the serum level of bilirubin decreased to the normal level.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of bilirubin. Timepoint: Baseline and then daily during the study. Method of measurement: blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospital stay. Timepoint: During hospital stay. Method of measurement: The number of days that neonate is hospitalized.</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>Shahrekord University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-02-20</approval_date>
        <contact_name>Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Shahrekord University of Medical Sciences Shahrekord  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
