<?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>IRCT2016072629026N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-29</date_registration>
      <primary_sponsor>Hormozgan Science &amp; Technology Park</primary_sponsor>
      <public_title>Herbal drug for treatment of  Irritable bowel syndrome (IBS)</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 Irritable bowel syndrome (IBS).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23417</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, GP 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>Irritable bowel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: ntervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit, Zataria Multifora and Dill oil, 2 times a day for 2 weeks. Intervention 2: Control group: Prescription of hyoscine 10 mg tablet three times 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>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, Iran.</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7915915517</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>ghasem.bordbar@hums.ac.ir</email>
        <affiliation>Hormozgan University of Medical Science</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>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7915915517</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>ghasem.bordbar@hums.ac.ir</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 Irritable bowel syndrome based on the ROME III criteria.</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 intestinal cancers, other chronic digestive diseases and peptic ulcer disease based on patient history, physical examination and medical records.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome</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>ntervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit, Zataria Multifora and Dill oil, 2 times a day for 2 weeks.</i_keyword>
      <i_keyword>Control group: Prescription of hyoscine 10 mg tablet three times a day for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention, end of intervention and 2 weeks after intervention. Method of measurement: IBS Quality of life(IBS-QOL).</prim_outcome>
      <prim_outcome>Relife of symptoms. Timepoint: End of intervention and 2 weeks after intervention. Method of measurement: IBS Adequate relief (IBS-AR).</prim_outcome>
      <prim_outcome>Relife of symptoms. Timepoint: End of intervention and 2 weeks after intervention. Method of measurement: IBS Global Assessment improvement(IBS-GAI).</prim_outcome>
      <prim_outcome>Average score of IBS Symptom Severity Scale(IBS-SSS). Timepoint: Before intervention, end of intervention and 2 weeks after intervention. Method of measurement: IBS Symptom Severity Scale(IBS-SSS).</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>Liver enzymes disorder. Timepoint: Before and after intervention. Method of measurement: Labratory test(AST,ALT,ALP,Billi T,D).</sec_outcome>
      <sec_outcome>Renal dysfunction. Timepoint: Before and after intervention. Method of measurement: Labratory test(BUN,Cr).</sec_outcome>
      <sec_outcome>Drug side effects. Timepoint: During and after intervention. Method of measurement: Entry the side effects by patient and clinical caregiver 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>Ethics committee 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>
