<?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>IRCT201506181165N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-13</date_registration>
      <primary_sponsor>Research deputy of Baqiyatallah University of Medical Sciences</primary_sponsor>
      <public_title>Examining the effect of NAC tablet on improving lung problems caused by mustard gas in chemically-wounded patients and veterans</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of efficacy and safety of Iranian version of NAC and comparing it with foreign sample of NAC in controlling pulmonary symptoms caused by sulfur mustard in chemically-wounded patients and veterans</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/307</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: We used the block randomization technique as the randomization procedure in our trial; if Oslyt group is shown by the letter A and Fluimucil group by B, randomization blocks are quaternary, i.e., AABB, BBAA, BABA, ABBA, ABAB and BAAB. In total, 21 blocks are established and patients are allocated to Oslyt or Fluimucil by these blocks and therefore, randomized.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic respiratory disorders caused by chemical weapons (sulfur mustard; mustard gas).</hc_freetext>
      <i_freetext>Intervention 1: In the control group, patients consume the standard treatment of Foreign NAC (Fluimucil) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for four months. Intervention 2: In the intervention group, patients consume the Iranian NAC (Oslyt) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for four months.</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. Yunes Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Sheykhbahaei st., Mollasadra st., Vanak square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8248 2507</telephone>
        <email>yunespanahi@yahoo.com circevaluations@yahoo.com</email>
        <affiliation>Baqiyatallah University of Medical Sciences-Chemical Injuries Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Aboutaleb Simiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Sheykhbahaei st., Mollasadra st., Vanak square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8248 2507</telephone>
        <email>mghanei@hbi.irm.ghanei@bmsu.ac.ir</email>
        <affiliation>Chemical Injuries Research Center, Baqiyatallah University of Medical sciences, Qazvin University of</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: documented exposure to sulfur mustard; documented diagnosis of chronic pulmonary disease due to mustard gas (histological evidence from previous biopsies); no history of tuberculosis; no history of resection of one or more lobes of lung&#13;
&#13;
Exclusion criteria: pneumonia; acute bronchitis; smoking cigarettes; being a substance abuser; any illness in which the medications could not be stopped; occurrence of any severe side effects of N-acetylcysteine (anaphylactoid reaction); use of any kind of antioxidant drugs; deterioration of clinical conditions during the course of the study; consuming less than 80% of allocated NAC medication</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J68.4, Y36</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>due to inhalation of chemicals, gases, fumes and vapours</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>In the control group, patients consume the standard treatment of Foreign NAC (Fluimucil) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for four months</i_keyword>
      <i_keyword>In the intervention group, patients consume the Iranian NAC (Oslyt) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for four months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cough. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: likert scale from 1 to 5: 1=I did not have cough 2=I have cough, but it is not a serious problem 3=I have cough, sometimes disturbs my work 4=I have disturbing cough, usually disturbs my work 5=I have disturbing cough, always disturbs my work.</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: likert scale from 1 to 5: 1=There is no dyspnea 2=Dyspnea only in extraordinary exercises 3=Dyspnea in ordinary exercise 4=Dyspnea in mild exercise 5=Dyspnea in rest.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wake-up dyspnea. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: likert scale from 1 to 4: 1=I never woke up due to dyspnea 2=I wake up less than once a week 3=I wake up once a week 4=I wake up more than twice a week.</sec_outcome>
      <sec_outcome>Side effects of Iranian NAC (Oslyt) and Foreign NAC (Fluimucil). Timepoint: At the end of the second week of the trial. Method of measurement: At the end of the second week of the trial and in a clinical visit, patients in both groups were asked about the side effects of NAC including nausea, vomiting, unpleasant taste of tablet, gastrointestinal distress, diarrhea, constipation and symptoms related to anaphylactoid reactions like urticaria, rash, suffocation feeling, dysphagia, dizziness, reduced blood pressure, pruritus and etc.</sec_outcome>
      <sec_outcome>Sputum. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: Sputum was reported as 0 for absence and 1 for presence.</sec_outcome>
      <sec_outcome>Delta Cough. Timepoint: Four months after intervention (end of intervention). Method of measurement: Cough Score at month 4 minus cough score at month 0.</sec_outcome>
      <sec_outcome>Delta dyspnea. Timepoint: Four months after intervention (end of intervention). Method of measurement: Dyspnea Score at month 4 minus dyspnea score at month 0.</sec_outcome>
      <sec_outcome>Delta Wake-up dyspnea. Timepoint: Four months after intervention (end of intervention). Method of measurement: Wake-up Dyspnea Score at month 4 minus wake-up dyspnea score at month 0.</sec_outcome>
      <sec_outcome>FEV1. Timepoint: Before intervention, two months after intervention, four months after intervention (end of intervention). Method of measurement: Measured by a HI-801 Chest M.I. Spirometer, Tokyo, Japan and unit of measurement is liter.</sec_outcome>
      <sec_outcome>FVC. Timepoint: Before intervention, two months after intervention, four months after intervention (end of intervention). Method of measurement: Measured by a HI-801 Chest M.I. Spirometer, Tokyo, Japan and unit of measurement is liter.</sec_outcome>
      <sec_outcome>FEV1/FVC. Timepoint: Before intervention, two months after intervention, four months after intervention (end of intervention). Method of measurement: FEV1 divided by FVC that has no specific unit.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Osvah Pharmaceutical Company</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research deputy of Baqiyatallah University of Medical Sciences</source_name>
      <source_name>Osvah Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-17</approval_date>
        <contact_name>Ethics Committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah University of Medical Sciences, Sheykh Bahaei-South st., Mollasadra st., Vanak square, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
