<?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>IRCT201103011155N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-03</date_registration>
      <primary_sponsor>Vince chancellor for reaserch guilan univercity of medical sciences</primary_sponsor>
      <public_title>Comparing regimens ( Bismuth sub-citrate , Omeprazole , Amoxicillin , Clarithromycin , Tinidazole ) and ( Bismuth sub citrate , Omeprazole , Tetracycline , Metronidazole , Ofloxacin ) on the eradication rate of Helicobacter pylori infection in non responder dyspeptic patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the five-drug regimen ( Bismuth sub-citrate , Omeprazole , Amoxicillin , Clarithromycin , Tinidazole ) and ( Bismuth sub citrate , Omeprazole , Tetracycline , Metronidazole , Ofloxacin ) on the eradication rate of Helicobacter pylori infection in non responder dyspeptic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/236</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: The first group treated with diet five drug protocol I ( Bismuth sub citrate 240 miligeram two time in day Construction Company Kimdaru drug 120 miligeram of two every 12 hours is given , Omeprazole 20 miligeram two time in day Construction Company doctor abidi capsule 20 miligeram every 12 hours of a number , Amoxicillin 1 geram two time in day Construction Co , two 500 mg capsules every 12 hours , Clarithromycin 500 miligeram two time in day Abbott Construction Company a number every 12 hours , making pars Tinidazole 500 miligeram two time in day drug every 12 hours that a number of drug to be prescribed for a week. Intervention 2: Another group treated with protocol II (Bismuth sub citrate 240 miligeram two time in day Construction Co Kimydaru  one number per 12 hours , Omeprazole 20 miligeram two time in day Construction Company doctor abidi a number every 12 hours , Tetracycline 500 miligeram two time in day Construction Company Razak two every 12 hours , Metronidazole 500 miligeram two time in day  Construction Company Alborz number every 12 hours , Ofloxacin  200 miligeram two time in day Construction Co. exir number every 12 hours a week will be given.</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>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 1553 5116</telephone>
        <email>info@gldrc.org</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 1553 5116</telephone>
        <email>info@gldrc.org</email>
        <affiliation>Gastrointestinal and Liver Diseases Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion: In this study , helicobacter pylori positive patients over 15 years and less than 65 years that under drug treatment regiment  quadriple or triple placed urea breath test (UBT) using carbon 14 (C14 or C13 or stoolAg) with the European protocol again have been positive , will enter the study. &#13;
Exclusion : Pregnant women , Patients with gastric malignancy , Cirrhosis , Patients with allergy to Amoxicillin or Clarithromycin , Omeprazole , Tetracycline , Ofloxacin , Metronidazole and Tinidazole , Colestramin Consumption , Renal failure , History of seizures , Blood disorders , Fauvism and treatment of patients with incomplete (less than 80%) will be excluded.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dyspepsia</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>The first group treated with diet five drug protocol I ( Bismuth sub citrate 240 miligeram two time in day Construction Company Kimdaru drug 120 miligeram of two every 12 hours is given , Omeprazole 20 miligeram two time in day Construction Company doctor abidi capsule 20 miligeram every 12 hours of a number , Amoxicillin 1 geram two time in day Construction Co , two 500 mg capsules every 12 hours , Clarithromycin 500 miligeram two time in day Abbott Construction Company a number every 12 hours , making pars Tinidazole 500 miligeram two time in day drug every 12 hours that a number of drug to be prescribed for a week.</i_keyword>
      <i_keyword>Another group treated with protocol II (Bismuth sub citrate 240 miligeram two time in day Construction Co Kimydaru  one number per 12 hours , Omeprazole 20 miligeram two time in day Construction Company doctor abidi a number every 12 hours , Tetracycline 500 miligeram two time in day Construction Company Razak two every 12 hours , Metronidazole 500 miligeram two time in day  Construction Company Alborz number every 12 hours , Ofloxacin  200 miligeram two time in day Construction Co. exir number every 12 hours a week will be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Helicobacter pylori eradication. Timepoint: 12 week. Method of measurement: ureas breath test with c14 and stool antigen.</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>Vince chancellor for reaserch guilan univercity of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-03-03</approval_date>
        <contact_name>Guilan University of Medical Sciences. Ethics Committee Gastrointestinal and Liver Diseases Research</contact_name>
        <contact_address>Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
