<?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>IRCT20170829035966N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-17</date_registration>
      <primary_sponsor>Vice Chancellor for research of Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Laughter Yoga and anti-anxiety drugs on irritable bowel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Laughter Yoga and anti-anxiety medication on anxiety and gastrointestinal symptoms of patients with irritable bowel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27026</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomizashin by sealed envelope.</study_design>
      <phase>2</phase>
      <hc_freetext>Irritable Bowel Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention in the first intervention group:Laughter Yoga:Laughter Yoga combines unconditional laugh with yoga breathing and yoga stretching exercises, and people laughing without any jokes. Meetings will be held once a week. there are seven Meetings of stress management therapy by Laughter Yoga, each meetings duration are one hour, a first meeting is justification of Laughter Yoga for participants, and the next five meetings are training and practice of laughing techniques, and the last meeting is practice and repetition of training of the previous one will be. Severity scorring system of irritable bowel syndrome designed by Francis CY in 1997. Mild (score 8 to 18), moderate (score 18 to 30) and severe (above 30). Intervention 2: Intervention in the second intervention group:&#13;
Anti-anxiety treatment:&#13;
Sertraline, 50 mg orally once a day for seven weeks. Intervention 3: Control group:&#13;
Symptomatic treatment with loperamide and hyoscine&#13;
Loperamide: 2 mg orally three to four times a day for seven weeks&#13;
Hyoscine: 20 mg orally four times a day for seven 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more informations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Davoody Navid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Birjand University of Medical Sciences, Ghaffari street, Birjand</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187874151</zip>
        <telephone>+98 51 3761 3026</telephone>
        <email>Dr.n.davoody@gmail.com</email>
        <affiliation>Faculty of medicine, Birjand University of Medical Sciences, Birjand, South Khorasan, Iran.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Tavakoli Tahmine</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Birjand University of Medical Sciences, Ghaffari Street, Birjand</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187874151</zip>
        <telephone>+98 51 3761 3026</telephone>
        <email>Tahminetavakoli95238@yahoo.com</email>
        <affiliation>Faculty of medicine, Birjand University of Medical Sciences, Birjand, South Khorasan, Iran.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged between 18 and 50 years old
Patients who accepted to participate in the study after explaining the purposes of the study and advantages and disadvantages of the interventions
There should be the possibility to keep the type and dose of the medications fixed during the study
Patients who do not have psychotic or personality disorders
Patients who do not have alarm signs including gastrointestinal bleeding, blood in stool, fever, weight loss, anemia, diarrhea at night, severe abdominal pain and so on</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who receive psychological treatments before entering the study
Patients who have any other anatomical or functional gastrointestinal disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K58.9, K58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome without diarrhoea ,Irritable bowel syndrome with diarrhoea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention in the first intervention group:Laughter Yoga:Laughter Yoga combines unconditional laugh with yoga breathing and yoga stretching exercises, and people laughing without any jokes. Meetings will be held once a week. there are seven Meetings of stress management therapy by Laughter Yoga, each meetings duration are one hour, a first meeting is justification of Laughter Yoga for participants, and the next five meetings are training and practice of laughing techniques, and the last meeting is practice and repetition of training of the previous one will be. Severity scorring system of irritable bowel syndrome designed by Francis CY in 1997. Mild (score 8 to 18), moderate (score 18 to 30) and severe (above 30)</i_keyword>
      <i_keyword>Intervention in the second intervention group:&#13;
Anti-anxiety treatment:&#13;
Sertraline, 50 mg orally once a day for seven weeks</i_keyword>
      <i_keyword>Control group:&#13;
Symptomatic treatment with loperamide and hyoscine&#13;
Loperamide: 2 mg orally three to four times a day for seven weeks&#13;
Hyoscine: 20 mg orally four times a day for seven weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Irritable Bowel Syndrome severity. Timepoint: Before and right after the end of intervention. Method of measurement: Irritable Bowel Syndrome severity score system designed by Francis CY in 1997: mild (8 to 18) - moderate (18 to 30) - severe ( more than 30).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety severity. Timepoint: Before and right after the end of intervention. Method of measurement: Anxiety score from beck anxiety inventory.</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 Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-21</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Faculty of medicine, Birjand University of Medical Sciences, Ghaffari street, Birjand Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
