<?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>IRCT2015082323736N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-09</date_registration>
      <primary_sponsor>Vice chancellor for research, Lorestan University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of sequential therapy in eradication of Helicobacter Pylori</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two Sequential therapy regimens and Standard Triple-Drug therapy for eradication of Helicobacter Pylori in patients with Dyspepsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20232</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Dyspepsia. Condition 2: Helicobacter pylori.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 3 (Control group):&#13;
Standard triple therapy with Omeprazole 20 mg capsule twice a day, Amoxicillin 1 g capsule twice a day and Clarithromycin 500 mg capsule twice a day for 2 weeks. Intervention 2: Intervention 1:&#13;
The sequential regimen is including Omeprazole 20 mg capsule twice a day  and Amoxicillin 1 g capsule twice a day  for the first week and Omeprazole 20 mg capsule twice a day, Clarithromycin 500 mg capsule twice a day and Metronidazole 500 mg tablet twice a day for the second week. Intervention 3: Intervention 2:&#13;
The sequential regimen is including Omeprazole 20 mg capsule twice a day  and Amoxicillin 1 g capsule twice a day  for the first week and Omeprazole 20 mg capsule twice a day, Levofloxacin 500 mg capsule twice a day and Metronidazole 500 mg tablet twice a day for the second week.</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>Mosayeb Moradniani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad,  Lorestan</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819617691</zip>
        <telephone>+98 66 3341 1439</telephone>
        <email>dr.m.morad@lums.ac.ir</email>
        <affiliation>Lorstan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mosayeb Moradniani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad,  Lorestan</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819617691</zip>
        <telephone>+98 66 3341 1439</telephone>
        <email>dr.m.morad@lums.ac.ir</email>
        <affiliation>Lorstan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with Dyspepsia for whom endoscopy was performed and those ones that have the positive Helicobacter Pylori infection based on pathology result and those who have not been treated for Helicobacter Pylori eradication before.&#13;
Exclusion criteria: Patients that need more treatments based on endoscopy results, patients that have severe underling diseases (heart disease, kidney disease, liver disease, etc), pregnant and lactating women, patients who have allergies to drugs we want to use.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K30</hc_code>
      <hc_code>B98.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dyspepsia</hc_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>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 3 (Control group):&#13;
Standard triple therapy with Omeprazole 20 mg capsule twice a day, Amoxicillin 1 g capsule twice a day and Clarithromycin 500 mg capsule twice a day for 2 weeks</i_keyword>
      <i_keyword>Intervention 1:&#13;
The sequential regimen is including Omeprazole 20 mg capsule twice a day  and Amoxicillin 1 g capsule twice a day  for the first week and Omeprazole 20 mg capsule twice a day, Clarithromycin 500 mg capsule twice a day and Metronidazole 500 mg tablet twice a day for the second week</i_keyword>
      <i_keyword>Intervention 2:&#13;
The sequential regimen is including Omeprazole 20 mg capsule twice a day  and Amoxicillin 1 g capsule twice a day  for the first week and Omeprazole 20 mg capsule twice a day, Levofloxacin 500 mg capsule twice a day and Metronidazole 500 mg tablet twice a day for the second week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Eradication of Helicobacter Pylori. Timepoint: 6 weeks after the completion of treatment course. Method of measurement: (UBT) Urea Breath Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of drugs. Timepoint: 2 Weeks After Beginning of Treatment. Method of measurement: Questionnaire.</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, Lorestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-05</approval_date>
        <contact_name>Ethics committee of Lorstan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences, Pardis campus, Kamalvand,  Khorramabad,  Lorestan Khorramabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
