<?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>IRCT20200907048643N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-14</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of three-drug and consecutive treatment regimens in the eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of three-drug and consecutive treatment regimens in the eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>270</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50770</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Gastrointestinal patients were selected after entering the gastrointestinal clinic and were randomly divided into three groups. A total of 270 patients were selected in groups of 90 with three, The groups were divided into each of which was randomly given one of the drug groups.The tool for making random blocks was https://www.sealedenvelope.com.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Comparison of three-drug and consecutive treatment regimens in eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First group: omeprazole 20mg twice daily + amoxicillin one gram twice daily + clarithromycin 500mg twice daily for 10 days Second group: omeprazole 20mg twice daily + amoxicillin one gram daily for 2 weeks + levofloxacin 500mg Twice a day in the first week of the diet and the third group: omeprazole 20mg twice daily + amoxicillin one gram twice daily for 5 days + metronidazole 500mg twice daily for the second 5 days + clarithromycin 500mg twice daily for 5 second day. Intervention 2: Intervention group: Group 2: omeprazole 20mg twice daily + amoxicillin 1 g daily for 2 weeks + levofloxacin 500mg twice daily in the first week of the diet. Intervention 3: Intervention group: Group 3: omeprazole 20mg twice daily + amoxicillin one gram twice daily for 5 days + metronidazole 500mg twice daily for the second 5 days + clarithromycin 500mg twice daily for the second 5 days.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
It is about the best treatment.

When:
Always

To whom:
Researcher

Conditions:
Always

Where to obtain:
Patients referred to the gastrointestinal clinic

How to obtain:
It does not have a specific process

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Reza Mehryar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Streat Resalt</address>
        <city>Urima</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>omid.garkaz23@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Reza Mehryar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Resalt Streat</address>
        <city>Urima</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>Hamidrezamehryar2010@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Endoscopic primary infection of Helicobacter pylori
2-Have symptoms of dyspepsia for at least 6 months or more
3- No history of taking any antibiotics during the last month and no history of taking proton and antacid pump inhibitors in the last month</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1- Endoscopic primary infection of Helicobacter pylori
2-Have symptoms of dyspepsia for at least 6 months or more
3- No history of taking any antibiotics during the last month and no history of taking proton and antacid pump inhibitors in the last month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oesophagitis</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 group: First group: omeprazole 20mg twice daily + amoxicillin one gram twice daily + clarithromycin 500mg twice daily for 10 days Second group: omeprazole 20mg twice daily + amoxicillin one gram daily for 2 weeks + levofloxacin 500mg Twice a day in the first week of the diet and the third group: omeprazole 20mg twice daily + amoxicillin one gram twice daily for 5 days + metronidazole 500mg twice daily for the second 5 days + clarithromycin 500mg twice daily for 5 second day</i_keyword>
      <i_keyword>Intervention group: Group 2: omeprazole 20mg twice daily + amoxicillin 1 g daily for 2 weeks + levofloxacin 500mg twice daily in the first week of the diet</i_keyword>
      <i_keyword>Intervention group: Group 3: omeprazole 20mg twice daily + amoxicillin one gram twice daily for 5 days + metronidazole 500mg twice daily for the second 5 days + clarithromycin 500mg twice daily for the second 5 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Helicobacter pylori treatment. Timepoint: Patients were referred to the clinic 2 weeks, 6 weeks and 10 weeks after starting treatment. Patients were examined for Helicobacter pylori by Stool Ag test. Individuals who were registered for successful negative test treatment for H. pylori eradication. In the second week visit, all side effects including (bad taste, dry mouth, diarrhea, confusion, tongue burn, nausea and vomiting, abdominal pain, constipation and headache) and patient compliance were recorded based on the number of pills remaining and then four weeks PPI only It was taken and then they did not take any PPI and antibiotics for 4 weeks and then it was proved by Stool Ag eradication of Helicobacter pylori infection in each group. Method of measurement: Blood and stool tests.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-03</approval_date>
        <contact_name>Urmia University of Medical Sciences</contact_name>
        <contact_address>Resalat Street, next to the provincial emergency room Urima West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
