<?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>IRCT2013031012765N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-21</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology- Golestan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison efficacy of tow serum therapy methods (serum with bicarbonate and without bicarbonate with soduim) in some factors (cratinin, pH of urine, term negative UA in terms of hemoglobin and granular casts)  patients with hemolysis caused by glucose 6-phosphate dehydrogenase enzyme deficiency in Taleghani hospital, Gorgan</public_title>
      <acronym></acronym>
      <scientific_title>considering  effect of serum with bicarbonate and serum without bicarbonate with soduim in treatment of hemolysis caused by glucose 6-phosphate dehydrogenase deficiency</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12760</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemolysis due to glucose 6-phasphate deficiency.</hc_freetext>
      <i_freetext>Intervention 1: treatment by serum with bicarbonate, 1.5 times of Maintaining serum volume of dextrose water 5% and for 100 mililiter, 3 meq/lit of bicarbonate. Intervention 2: treatment by serum with bicarbonate, 1.5 times of Maintaining serum volume of dextrose water 5% and for 100 mililiter, 3 meq/lit of NaCl.</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>Narges beigom Mirbehbahani, Skineh Mohammadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, Janbazan Boulevard</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 1232 8539</telephone>
        <email>n.mirbehbahani@gmai.com, saminmohammadian@gami.com</email>
        <affiliation>Hematology &amp; Oncology Research Center, Golestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges beigom Mirbehbahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, Janbazan Boulevard</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 1232 8539</telephone>
        <email>n.mirbehbahani@gmail.com</email>
        <affiliation>Hematology and Oncology Research Center, Golestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria is just  diagnosis favism. Beans consumption and Highlighted in urine are the first items for diagnosis of favism and it is confirmed  by urinalysis that  is Hemoglobinuria positive. Exclusion criteria is dissatisfaction.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D55.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anaemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency</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>treatment by serum with bicarbonate, 1.5 times of Maintaining serum volume of dextrose water 5% and for 100 mililiter, 3 meq/lit of bicarbonate</i_keyword>
      <i_keyword>treatment by serum with bicarbonate, 1.5 times of Maintaining serum volume of dextrose water 5% and for 100 mililiter, 3 meq/lit of NaCl.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemoglpbine. Timepoint: befor intevention and after intervention, befor discharge. Method of measurement: g/dl- according to tests.</prim_outcome>
      <prim_outcome>Cereatinine. Timepoint: befor intevention and after intervention, befor discharge. Method of measurement: mg/dl- according to tests.</prim_outcome>
      <prim_outcome>PH of urine. Timepoint: befor intevention and after intervention, befor discharge. Method of measurement: by pH meter.</prim_outcome>
      <prim_outcome>UA-cast. Timepoint: befor intevention and after intervention, befor discharge. Method of measurement: BY Urinanalysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time of admission until discharge. Timepoint: at discharge. Method of measurement: Measuring the time from the moment of admission to hospital discharge.</sec_outcome>
      <sec_outcome>Number of blood transfusion. Timepoint: during treatment. Method of measurement: The frequency of blood transfusion.</sec_outcome>
      <sec_outcome>Blood volume injected for each time. Timepoint: during intervention. Method of measurement: ml- Based on the amount of blood recieved at every turn.</sec_outcome>
      <sec_outcome>Time to clear urine. Timepoint: at the end of intervention. Method of measurement: being negative urine from hemoglobinuria.</sec_outcome>
      <sec_outcome>Side effects of ficarbonate. Timepoint: after intervention. Method of measurement: basis on observed side effects.</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>Vice Chancellor for Research and Technology- Golestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-13</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Falsafi Higher Education Bilding, Bigining of Shatkola Roade Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
