<?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>IRCT20230202057305N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of furazolidone drug for the treatment of stomach bacterial infection</public_title>
      <acronym>no</acronym>
      <scientific_title>Comparison of efficacy and safety of quadruple regimens containing furazolidone in patients with Helicobacter pylori infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68820</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple. Randomization unit: individual. Randomization tool: randomization using the site http://www.randomizer.0rg, which is extracted using random numbers obtained by the software, patients are divided into one of 3 groups: Amoxicillin A, Tetracycline T, and Levofloxacin L. In other words, We extract random numbers based on the number of samples introduced on the site, Blinding description: The patients were randomly selected and placed in groups that were unaware of the other groups, and the medication package was delivered to them in coded form.</study_design>
      <phase>2</phase>
      <hc_freetext>H. pylori infection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First intervention group: furazolidone, proton pump inhibitor, bismuth, amoxicillin. . which is in the form of furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, and amoxicillin 1000 every 12 hours and from Obeid Pharmaceutical Company for 10-14 days. Intervention 2: Intervention group: second intervention group: furazolidone, proton pump inhibitor, bismuth, tetracycline. Furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, tetracycline 500 every 6 hours. From Obeid Pharmaceutical Company for 10-14 days. Intervention 3: Intervention group: The third intervention group: furazolidone, proton pump inhibitor, bismuth, levofloxacin in the form of furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, and levofloxacin 500 daily from Obeid Pharmaceutical Company for 10-14 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:
All data can be shared after de-identification

When:
6 months after the results are published

To whom:
public

Conditions:
Scientific and therapeutic research

Where to obtain:
Send your request to maryam.moghadam201@gmail.com

How to obtain:
Just submit your request in email
maryam.moghadam201@gmial.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Maryam Moghadam Ziabari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabatabai St. - Stovar Alley - No. 5</address>
        <city>Masal</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4381965747</zip>
        <telephone>+98 13 4468 2868</telephone>
        <email>maryam.moghadam201@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Maryam Moghadam Ziabri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabatabai St. - Stovar Alley - No. 5</address>
        <city>Masal</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4381965747</zip>
        <telephone>+98 13 4468 2868</telephone>
        <email>maryam.moghadam201@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of H. pylori infection in patients by standard diagnostic methods
Over seventeen years of age</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of known drug sensitivity to the studied drug regimen
pregnancy
Having chronic diseases (pulmonary, kidney, liver)
Unwillingness to participate in the study
Patients treated with other treatment methods such as probiotics, other antibiotics, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B96.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere</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 intervention group: furazolidone, proton pump inhibitor, bismuth, amoxicillin. . which is in the form of furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, and amoxicillin 1000 every 12 hours and from Obeid Pharmaceutical Company for 10-14 days.</i_keyword>
      <i_keyword>Intervention group: second intervention group: furazolidone, proton pump inhibitor, bismuth, tetracycline. Furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, tetracycline 500 every 6 hours. From Obeid Pharmaceutical Company for 10-14 days</i_keyword>
      <i_keyword>Intervention group: The third intervention group: furazolidone, proton pump inhibitor, bismuth, levofloxacin in the form of furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, and levofloxacin 500 daily from Obeid Pharmaceutical Company for 10-14 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Eradication and safety of drug regimens containing furazolidone in patients with H. pylori infection. Timepoint: Investigating the eradication rate of H. pylori two weeks after the end of the treatment regimen. Method of measurement: Standard diagnostic methods include RUT, histology staining, bacterial culture, antigen test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>H. pylori eradication, drug safety. Timepoint: Two weeks after the end of the eradication treatment. Method of measurement: Urea breath test, fecal antigen, bacterial culture, histology.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-22</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti Medical School</contact_name>
        <contact_address>Masal - Shahid Tabatabai St. - Stovar Alley - No. 5 Masal Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
