<?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>IRCT2014100419330N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-11-22</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Arak University of Medical Science</primary_sponsor>
      <public_title>A comparison between effects of Glycyrrhiza glabra and Zataria multiflora on gastrointestinal disorders of ICU nurses</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Liquorice and Zataria multiflora effects on gastrointestinal symptoms in ICU and CCU nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17306</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: A random number between 1 and 105 is assigned to each of nurses (satisfying inclusion criteria) and then they classified to three groups via random number generation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Irritable bowel syndrome. Condition 2: Constipation. Condition 3: Functional diarrhoea. Condition 4: Fissure and fistula of anal and rectal regions. Condition 5: Abscess of anal and rectal regions. Condition 6: Other diseases of anus and rectum. Condition 7: Other diseases of intestine. Condition 8: Other specified diseases of digestive system. Condition 9: Disease of digestive system, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: First intervention group treatment is carried out via Glycyrrhiza glabra (3 capsule D-reglis: 650mg per day) during 4 weeks. Intervention 2: Control group: In control group, placebo is utilized (3 capsule starches per day) during 4 weeks. Intervention 3: Second intervention group: Second intervention group treatment is carried out via Zataria multiflora (3 capsule gastrolit: 20 mg per day) during 4 week.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sharareh Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir-al-momenin hospital, Basij square, Sardasht, Arak, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>shararehkh2011@yahoo.com</email>
        <affiliation>Arak university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sharareh khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir-al-momenin hospital, Basij square, Sardasht, Arak, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>shararehkh2011@yahoo.com</email>
        <affiliation>Arak university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  To be eligible for this trial, each volunteer needs to meet the following criteria at a screening and baseline visit: Volunteers between 20 to 55 years old, male or female, capable of giving informed consent, to have at least 1 year record of service in intensive care unit, and affected by gastrointestinal disturbances during the last weak.&#13;
&#13;
Exclusion criteria: Nonconformity with medication regimen, being affected by any severe systemic diseases. Moreover, volunteers that are receiving any medical treatment of stress induced symptoms (such as sleeping pills, antidepressants, or anxiolytics) or those who have taken such treatment since 3 months ago or later are also excluded. In addition, those volunteers who are using nicotine or who have weaned since 6 months ago  are excluded.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k58</hc_code>
      <hc_code>k59.0</hc_code>
      <hc_code>k59.1</hc_code>
      <hc_code>k60</hc_code>
      <hc_code>k61</hc_code>
      <hc_code>k62</hc_code>
      <hc_code>k63</hc_code>
      <hc_code>k92.8</hc_code>
      <hc_code>K92.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome</hc_keyword>
      <hc_keyword>Constipation</hc_keyword>
      <hc_keyword>Functional diarrhoea</hc_keyword>
      <hc_keyword>Fissure and fistula of anal and rectal regions</hc_keyword>
      <hc_keyword>Abscess of anal and rectal regions</hc_keyword>
      <hc_keyword>Other diseases of anus and rectum</hc_keyword>
      <hc_keyword>Other diseases of intestine</hc_keyword>
      <hc_keyword>Other specified diseases of digestive system</hc_keyword>
      <hc_keyword>Disease of digestive system, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: First intervention group treatment is carried out via Glycyrrhiza glabra (3 capsule D-reglis: 650mg per day) during 4 weeks.</i_keyword>
      <i_keyword>Control group: In control group, placebo is utilized (3 capsule starches per day) during 4 weeks.</i_keyword>
      <i_keyword>Second intervention group: Second intervention group treatment is carried out via Zataria multiflora (3 capsule gastrolit: 20 mg per day) during 4 week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal pain. Timepoint: 4 weeks. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Pyrosis. Timepoint: 4 weeks. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in bowel habits (Constipation, Diarrhea). Timepoint: 4 Weeks. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Reflux. Timepoint: 4 Weeks. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Flatulence. Timepoint: 4 Weeks. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Xerostomia. Timepoint: 4 Weeks. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: 4 Weeks. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Abdominal pain caused by hunger. Timepoint: 4 Weeks. Method of measurement: Questionnaire.</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>Vice Chancellor for Research of Arak University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-22</approval_date>
        <contact_name>Ethics Committe of Arak University of Medical Science</contact_name>
        <contact_address>Basij square, Sardasht, Arak, Iran Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
