<?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>IRCT201708071155N26</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-08</date_registration>
      <primary_sponsor>Guilan Univercity of Medical Sciences</primary_sponsor>
      <public_title>The effect of fourteen days regimen of four medications “bismuthe subcirate, pantoprazole, amoxicilline, clarithromycin” and  seven days sequential regimen of “bismuthe subcirate, pantoprazole, amoxicilline, meteronidazole” and “bismuthe subcirate, pantoprazole, amoxicilline, furazolidone” in helicobacter pylori eradication</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of helicobacter pylori eradication of fourteen days regimen of four medications “bismuthe subcirate, pantoprazole, amoxicilline, clarithromycin” with seven days sequential regimen of “bismuthe subcirate, pantoprazole, amoxicilline, meteronidazole” and “bismuthe subcirate, pantoprazole, amoxicilline, furazolidone”</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>344</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/248</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No Comment.</study_design>
      <phase>3</phase>
      <hc_freetext>Helicobacter pylori.</hc_freetext>
      <i_freetext>Intervention group takethe 14 days treatment of  bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, clarithromycin 500 mg twice a day made by Actover , and the sequential regimen; first 7 days of bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, meteronidazole 500 mg twice a day made by abidi, and second 7 days with  bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, and furazolidone 100 mg twice a day made by Tehran Darou..</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>Dr.	Farahnaz Joukar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>955655-41448</zip>
        <telephone>+98 13 3353 5116</telephone>
        <email>farajov@gmail.com</email>
        <affiliation>Gastrointestinal and Liver Diseases Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Fariborz Mansour-Ghanei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95655-41448</zip>
        <telephone>+98 13 3353 5116</telephone>
        <email>ghanaie@yahoo.com</email>
        <affiliation>Gastrointestinal and Liver Diseases Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Inclusion criteria: Positive helicobacter pylori in the endoscopy and no therapeutic regimen for treatment &#13;
•	Exclusion criteria: Pregnant and breast feeding women, gastric and esophageal malignancy, cirrhosis, heart and kidney failure, history of seizure, hematologic diseases, and allergy to medications, patients with incomplete treatment period, severe side effects, and no satisfaction to continue treatment</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B98.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group takethe 14 days treatment of  bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, clarithromycin 500 mg twice a day made by Actover , and the sequential regimen; first 7 days of bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, meteronidazole 500 mg twice a day made by abidi, and second 7 days with  bismuthe subcirate 240 mg twice a day made by Kimidarou, pantoprazole 20 mg twice a day made by Takeda, amoxicilline 1 gr twice a day made by Kosar, and furazolidone 100 mg twice a day made by Tehran Darou.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Helicobacter pylori eradication. Timepoint: 12 weeks. Method of measurement: Ureas Breath Test with C14.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comparison of helicobacter pylori eradication of fourteen days regimen of four medications “bismuthe subcirate, pantoprazole, amoxicilline, clarithromycin” with seven days sequential regimen of “bismuthe subcirate, pantoprazole, amoxicilline, meteronidazole” and “bismuthe subcirate, pantoprazole, amoxicilline, furazolidone”. Timepoint: 2-4 weeks. Method of measurement: 2-4 weeks.</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>Guilan Univercity of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-12</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences.</contact_name>
        <contact_address>Gaz square ,Shaheed Beheshti street,Research and Technology Deputy Rasht, Iran Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
