<?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>IRCT20160721029026N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-31</date_registration>
      <primary_sponsor>Hormozgan Science &amp; Technology Park</primary_sponsor>
      <public_title>Herbal Drug for Treatment of Functional Dyspepsia and eradication of Helicobacter pylori(H.pylori) infection.</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of herbal drug that is composed of essential oil of Zataria Multiflora Boiss, Trachyspermum Ammi and Anethum Graveolens L, in treatment of Functional dyspepsia (FD) and eradication of Helicobacter pylori(H.pylori) infection.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23418</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization method and using the Random Allocation software, Blinding description: After the patient is visited and proved by gastroenterologist to have required conditions ,the informed consent is obtained from the patients and they will be referred to GP to receive the drug. By simple randomization method and using the random Allocation, General Practitioner puts the patients in two equal group of control and interference.The patients in the control group receive medicinal regimen of type A and the patients in the interference group receive the medicinal regimen of type B. The drugs are placed in the containers with the same shape and appearance with code of A and B on them by the way the patients are uninformed about the regimen type. Finally the assessment is done by a third individual (a trained medical student) that is uninformed about the type of regimen A and B.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Functional Dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit,zataria multifora,dill oil , 3 times a day for 20 days. Intervention 2: Control group: Prescription of Clarithromycin 500mg twice a day for 2 weeks, Amoxicillin 1gr twice a day for 2 weeks and Omeprazole 20 mg capsule once a day for 4 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is According to the subject of the study, which is about an invention. To prevent misuse of the details of the study information, there is currently no way to publish information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghasem bordbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.</address>
        <city>Bandar Abaas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7915915517</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>bordbarghasem1@yahoo.com</email>
        <affiliation>Student Research Comitte, Vice-chancellery for Research, Hormozgan University of Medical Siences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghasem Bordbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.</address>
        <city>Bandra Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7915915517</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>bordbarghasem1@yahoo.com</email>
        <affiliation>Student Research Comitte, Vice-chancellery for Research, Hormozgan University of Medical Siences.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Written consent and complete knowledge about the study; being diagnosed with Functional dyspepsia based on the ROME III criteria; The presence of H.pylori infection based on Stool antigen test.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The participants’ lack of consent to continue their participation in the study; kidney and liver diseases based on laboratory tests; warning symptoms of gastric and esophageal cancers, other chronic digestive diseases and peptic ulcer disease based on patient history, physical examination, laboratory tests and, if necessary, upper endoscopy.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dyspepsia</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: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit,zataria multifora,dill oil , 3 times a day for 20 days.</i_keyword>
      <i_keyword>Control group: Prescription of Clarithromycin 500mg twice a day for 2 weeks, Amoxicillin 1gr twice a day for 2 weeks and Omeprazole 20 mg capsule once a day for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average score of persons in Gastrointestinal Symptom Rating Scale (GSRS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).</prim_outcome>
      <prim_outcome>Average score of persons in GSRS abdominal pain. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).</prim_outcome>
      <prim_outcome>Epigastric pain syndrome(EPS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).</prim_outcome>
      <prim_outcome>Average score of persons in GSRS indigestion score. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).</prim_outcome>
      <prim_outcome>Postprandial distress syndrom. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: SF-36 Healthy Survey questionnaire.</prim_outcome>
      <prim_outcome>Eradication oh H.pylori infection. Timepoint: Before intervention, 2 weeks after intervention. Method of measurement: Stool Ag test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of drug consumption. Timepoint: after intervention. Method of measurement: By checking the residual amount of drug after intervention.</sec_outcome>
      <sec_outcome>Elevation of liver enzymes. Timepoint: Before and after intervention. Method of measurement: labratory test(AST,ALT,ALP,Billi T,D).</sec_outcome>
      <sec_outcome>Dysfunction of kidney. Timepoint: Before and after intervention. Method of measurement: labratory tests (BUN,Cr).</sec_outcome>
      <sec_outcome>Drug side effects. Timepoint: During an after intervention. Method of measurement: Entry the side effects by patient and Responsible for study in side effects form.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Hormozgan University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Hormozgan Science &amp; Technology Park</source_name>
      <source_name>Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-07</approval_date>
        <contact_name>Vice-chancellery for research of Hormozgan University of Medical Science</contact_name>
        <contact_address>Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
