<?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>IRCT2015050322049N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-06</date_registration>
      <primary_sponsor>Shahed University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Specific Dietary Interventions in Postprandial Distress Syndrom</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of effect of Specific Dietary Interventions on severity of Dyspepsia in patients with Postprandial Distress Syndrom</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: blocking
Randomization unit: individual
In this method, each person was considered as a block.
Because there were two groups of intervention (a) and control (b), it was determined based on quadruple blocks and by drawing blocks, and thus each person was placed in the intervention and control group. for example:
A B A B
B A A B
B B A A   ,......
Random allocation software was used for randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Functional dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks.                                                 In this diet,  based on the food groups of the new food guide pyramid whit observing the principle of Variety and balance, cold and wet, heavy, slow-digesting or indigestible foods, and harmful to the stomach (based on reliable sources of traditional Persian medicine) are removed from patients' diets. Appropriate and equivalent are replaced in the same group.This diet are given to the patients in the intervention group for two weeks. Intervention 2: Control group: continue previous diet without restriction.</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:
Some data, such as information about the main outcome or the like, can be shared.

When:
The description includes both the time period and the start date of the access

To whom:
Researchers working in academic and scientific institutions

Conditions:
In the form of publication of an article

Where to obtain:
To the site of reputable domestic and foreign magazines

How to obtain:
It depends on the acceptance and publication of the article in the intended journal

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Nouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tim Health care, Third Dashtestan Ave, Shariati Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 2288 2521</telephone>
        <email>fdr.nouri@gmail.com</email>
        <affiliation>Shahed University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Taleghani Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2561</telephone>
        <email>saeedabdi75@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with 18-75 years old;
Willing to cooperate;
Early Satiety or bothersome postprandial fullness more than 3 months;
Without Organic Disorders on physical examination;
normal Endoscopic.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with organic disorders; T
he use of Chemicals and Herbals any other medication;
History of Abdominal surgeries;
History of bloody diarrhea;
Pregnancy and breast feeding;
Lack of interest in work;
Not sign the consent.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Indigestion</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: special diet based on the recommendations of the Traditional Iranian Medicine for Two weeks.                                                 In this diet,  based on the food groups of the new food guide pyramid whit observing the principle of Variety and balance, cold and wet, heavy, slow-digesting or indigestible foods, and harmful to the stomach (based on reliable sources of traditional Persian medicine) are removed from patients' diets. Appropriate and equivalent are replaced in the same group.This diet are given to the patients in the intervention group for two weeks.</i_keyword>
      <i_keyword>Control group: continue previous diet without restriction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity Assessment of Dyspepsia. Timepoint: At baseline, 2 and 8 weeks after starting the intervention. Method of measurement: The Gastrointestinal Symptom Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postprandial fullness. Timepoint: At baseline, 2 and 8 weeks after starting the intervention. Method of measurement: The Gastrointestinal Symptom Scale.</sec_outcome>
      <sec_outcome>Early Satiety. Timepoint: At baseline, 2 and 8 weeks after starting the intervention. Method of measurement: The Gastrointestinal Symptom Scale.</sec_outcome>
      <sec_outcome>Bloating. Timepoint: At baseline, 2 and 8 weeks after starting the intervention. Method of measurement: The Gastrointestinal Symptom Scale.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: At baseline, 2 and 8 weeks after starting the intervention. Method of measurement: The Gastrointestinal Symptom Scale.</sec_outcome>
      <sec_outcome>Belching. Timepoint: At baseline, 2 and 8 weeks after starting the intervention. Method of measurement: The Gastrointestinal Symptom Scale.</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>Shahed University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-27</approval_date>
        <contact_name>Shahed University of Medical Sciences</contact_name>
        <contact_address>Opposite of Imam Khomeiny Shrine Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
