<?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>IRCT20160118026097N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-11</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of low dose and high dose of furazolidone in the treatment of Helicobacter pylori infection</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>Comparison of low dose and high dose of furazolidone in the treatment of Helicobacter pylori infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39664</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: This study will be performed by a random sampling method, block allocation. In such a way that In this study, 60 patients with corona will be randomly divided into two groups. The selection of groups will be based on the fact that individuals will be assigned to groups based on block randomization. Block size 4 is considered. So we have six blocks of four, ABAB, ABBA, AABB, BAAB BBAA, BABA. The selection of each block will also be random and will be done using dice. For example, if the number 5 comes in the dice roll, the AABB block is considered and Therefore, the first two patients are assigned to treatment A, and the two patients are then assigned to treatment B.The dice will be thrown ten times to complete the allocation of patients to treatment groups. Treatment with dexamethasone and control will also be based on accident (coin toss).</study_design>
      <phase>3</phase>
      <hc_freetext>Helicobacterpylori Eradication.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: After obtaining informed consent and full explanation of the treatment process to the patient and his companions regarding the treatment process, under low-dose four-drug treatment (OfAB) including amoxicillin mg-BD 1000, furazolidone mg-BD 100, omeprazole mg-BD20, and bismuth 240 mg-BD subcitrate for 2 weeks. Intervention 2: Intervention group 2: After obtaining informed consent and full explanation of the treatment process to the patient and his companions about the treatment process, under treatment with four high-dose drugs (OFAB) including: amoxicillin mg-BD 1000, furazolidone mg-BD 200, omeprazole mg-BD20 and bismuth sub-citrate 240 mg-BD for 2 weeks.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The final report is not completed.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>jamshid vafaeemanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qom - Shahid Lavasani Street (Coastal) - Qom University of Medical Sciences</address>
        <city>qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3612 2526</telephone>
        <email>jvafaeemanesh@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>jamshid vafaeemanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qom - Shahid Lavasani Street (Coastal) - Qom University of Medical Sciences</address>
        <city>qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3612 2526</telephone>
        <email>jvafaeemanesh@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Peptic ulcer diagnosis with endoscopic diagnosis test
Helicobacter pylori infection with RUT
consent to cooperate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Cancer or Liver Failure
Diabetes Mellitus
History of Cigarette
History of Alcohol
History of Drug Sensitivity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastric ulcer</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>Intervention group 1: After obtaining informed consent and full explanation of the treatment process to the patient and his companions regarding the treatment process, under low-dose four-drug treatment (OfAB) including amoxicillin mg-BD 1000, furazolidone mg-BD 100, omeprazole mg-BD20, and bismuth 240 mg-BD subcitrate for 2 weeks.</i_keyword>
      <i_keyword>Intervention group 2: After obtaining informed consent and full explanation of the treatment process to the patient and his companions about the treatment process, under treatment with four high-dose drugs (OFAB) including: amoxicillin mg-BD 1000, furazolidone mg-BD 200, omeprazole mg-BD20 and bismuth sub-citrate 240 mg-BD for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Response to treatment-Helicobacter pylori eradication after drug treatment with urease respiratory test. Timepoint: Six weeks after drug treatment. Method of measurement: Urease Respiratory Test.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-22</approval_date>
        <contact_name>Golestan University of Medical Sciences</contact_name>
        <contact_address>Golestan Research Center of Gastroenterology and Hepatology-GRCGH (GOUMS), Golestan      University of Medical Sciences, Gorgan, Iran gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
