<?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>IRCT20200128046288N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-24</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Study of Combinatory effect of Cydonia oblanga, Cinnamomum zeylanicom, Pistacia lentiscus and Honey in Eradication of Gastric Helicobacter pylori Infection</public_title>
      <acronym></acronym>
      <scientific_title>The Study of Combinatory effect of Cydonia oblanga, Cinnamomum zeylanicom, Pistacia lentiscus and Honey in Eradication of Gastric Helicobacter pylori Infection in patients with dyspepsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used Blocking is used to balance the number of samples assigned to each study group, because we have two intervention groups, use equal 4 blocks and create all 4 possible modes and then with Excel software we randomly select a number of blocks. The label of interventions to one of the letters A or B and the sequence of randomization determined by the statistical consultant. For allocation concealment, drug delivery and the sequence of randomization is not available to researchers and evaluators while is the responsibility of the off-site individual, Blinding description: Unique codes, which is generated by the software, will be used on the drug and  placebo boxes. By entering each individual into the study based on the produced sequence, the drug or placebo box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Helicobacter pylori and dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving routine treatment, 30 ml of herbal syrup will be taken twice a day for 2 weeks. The herbal syrup includes fruit of Quince, cinnamon, mastic and honey which will be made by the researchers of the project and based on the formula of Iranian traditional medicine resources. Intervention 2: Control group: In addition to receiving routine treatment, 30 ml of placebo syrup will be taken twice a day 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data will be shared

When:
The access time is up to 6 months after the results are published

To whom:
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis

Conditions:
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.

Where to obtain:
Applicants can email the responsible author to receive the requested data golfakhrabadi@yahoo.com

How to obtain:
Applicants will have access to the data from the present study by emailing the responsible author for up to one month.golfakhrabadi@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh golfakhrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733184</zip>
        <telephone>+98 61 3373 8378</telephone>
        <email>golfakhrabadi@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh golfakhrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733184</zip>
        <telephone>+98 61 3373 8378</telephone>
        <email>golfakhrabadi@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who have one or more symptoms of dyspepsia (based on the Reflux Disease Questionnaire (RDQ))
Patients over 18 years with H.pylori positive test
The women in the study had a negative pregnancy test</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a chronic illness that leads to long-term use of a variety of medications. (Cardiovascular diseases, liver failure, kidney failure)
Previous history of gastrointestinal ulcers or gastrointestinal bleeding
Gasteric cancer
Allergy to plants especially fruits of Quince, Cinnamon and mastic</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving routine treatment, 30 ml of herbal syrup will be taken twice a day for 2 weeks. The herbal syrup includes fruit of Quince, cinnamon, mastic and honey which will be made by the researchers of the project and based on the formula of Iranian traditional medicine resources.</i_keyword>
      <i_keyword>Control group: In addition to receiving routine treatment, 30 ml of placebo syrup will be taken twice a day for 2 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Burning sensation in the back of the chest. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Feeling of pain in the back of the chest. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Heartburn. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Feeling of upper abdominal pain. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Acid taste. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Feeling the material move towards the top of the stomach. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Beiching. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Contusion. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Swallowing disorder. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Bitter taste sensation. Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
      <prim_outcome>Feeling of movement of material in the stomach upwards (throat or mouth). Timepoint: Before and 2 week after the intervention. Method of measurement: Reflux Disease Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The rate of drug side effects. Timepoint: During drug use. Method of measurement: Patient Report.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-03</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی جندی شاپور اهواز</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences,, Golestan street Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
