<?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>IRCT20150927024228N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-08</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Apium graveolense and Trachyspermum copticum on postprandial syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Apium graveolense and Trachyspermum copticum  versus Domperidone on clinical symptoms of patients with postprandial distress syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37515</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are referred to a group of 6 blocks with 4 random sequences, respectively.
Sequences are based on the repetition of each of the two groups A, and B 6 blocks are randomly placed on the list. The patient will be referred to the list, respectively. for example: AABB, ABAB,, Blinding description: Medications are packaged and encoded by a third person who does not have a role until the end of the study and the researcher does not know about encoding. The general nature of the intervention groups is described to the patients before starting the study, But there is no information about the details of the group in which they are located.</study_design>
      <phase>3</phase>
      <hc_freetext>Functional dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Apium Graveolense beans 110 mg plus Trachyspermum Copticum beans 110 mg, three times daily,after meal, for 4 weeks. Intervention 2: Control group: Domperidone tablet 10 mg, three times daily, after meal, 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Articles

When:
6 months after printing of Articles

To whom:
Academic and Industrial Researchers

Conditions:
Demographic and symptom severity and quality of life information

Where to obtain:
E-mail

How to obtain:
1 month after request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirkabir Crossroad; Jomhuri Boulevard; Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3211 0123</telephone>
        <email>Dr.azimm@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirkabir Crossroad; Jomhuri Boulevard; Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 43 3211 0123</telephone>
        <email>Dr.azimm@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 60 year-old patients with functional dyspepsia
Presence of symptoms of postprandial distress syndrome</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and Lactation
History of convulsion
Use of chemical and herbal drugs of dyspepsia
Serious diseases like diabetes and cardiovascular diseases
History of gastrointestinal surgery
Severe mental retardation
Drug abuse
Use of anticoagulant drug
History of side effects related to use of herbal or chemical medicines
History of peptic ulcer or gastrointestinal reflux disease
Presence of any structural disorder in endoscopy during the last three months
Presence of irritable bowel syndrome
The patient's unwillingness to continue the study, or unwillingness to signing the concent form
Presence of any alarming sign (severe weight loss, anemia, bloody stool, difficult swallowing</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Functional 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: Apium Graveolense beans 110 mg plus Trachyspermum Copticum beans 110 mg, three times daily,after meal, for 4 weeks</i_keyword>
      <i_keyword>Control group: Domperidone tablet 10 mg, three times daily, after meal, for 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity assessment of dyspepsia. Timepoint: 4 times: baseline, 2,4 and 8 weeks. Method of measurement: The gastrointestinal severity symptom scale.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: 3 times: baseline, 4, 8 weeks. Method of measurement: NDI10 quality of life scale.</prim_outcome>
      <prim_outcome>Frequency assessment of dyspepsia. Timepoint: 4 times: baseline, 2,4 and 8 weeks. Method of measurement: Rome IV questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: During 8 weeks study. Method of measurement: Side effects questionnnaire.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-28</approval_date>
        <contact_name>Ethics Committe of Kerman University of Medical Sciences</contact_name>
        <contact_address>Shafa Crossroad; Jomhuri Boulevard; Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
