<?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>IRCT20220529055014N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-15</date_registration>
      <primary_sponsor>Bam University of Medical Sciences</primary_sponsor>
      <public_title>Effect of N-acetylcysteine ​​and bromhexine pneumothorax</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of N-acetylcysteine and bromhexine in patients with pneumothorax</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: First determine a total sample size then randomly Assign a set of them to group A and the rest to group B. For example, in a study with a sample size of 50 people, 25 balls for intervention group A and 25 balls for group Intervention B is placed inside a lottery container and then the balls are randomly recorded without being replaced from the container and the resulting sequence is recorded.</study_design>
      <phase>3</phase>
      <hc_freetext>Pneumothorax.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, pneumothorax patients are treated orally for one week by implanting chest tube and taking bromhexine tablets, a product of Aveh Sina Pharmaceutical Company, at a dose of 8 mg once a day. Then the patient is photographed chest and in case of recovery of pneumothorax, the time required for chest tube exit is recorded and examined. Intervention 2: Intervention group: In this group, pneumothorax patients are treated by chest tube implantation and N-acetylcysteine, a product of Aveh Sina Pharmaceutical Company, at a dose of 600 mg as a solution in 30cc of water, every 12 hours orally for one week. Take. Then the patient is photographed chest and in case of recovery of pneumothorax, the time required for chest tube exit is recorded and examined.</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:
Clinical information (including therapeutic outcomes) and demographics Pneumothorax patients treated with N-acetylcysteine ​​and bromhexine

When:
About a year

To whom:
Public

Conditions:
Detailed study information can be made available to interested researchers Treat patients

Where to obtain:
Author responsible for the study

How to obtain:
Competent and enthusiastic researchers can document the data after publication Work of the responsible author by providing academic information and self-identification To receive

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bam - Persian Gulf Highway - University Campus</address>
        <city>Bam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7661771967</zip>
        <telephone>+98 34 4421 9074</telephone>
        <email>Hossein.rezaei.aliabadi@gmail.com</email>
        <affiliation>Bam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Khojandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bam - Persian Gulf Highway - University Campus</address>
        <city>Bam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7661771967</zip>
        <telephone>+98 34 4421 9074</telephone>
        <email>Mojtabakhojandi@gmail.com</email>
        <affiliation>Bam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient admitted to the surgical ward
Satisfaction with participation in the study
Patients with traumatic pneumothorax to a significant extent</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with chronic obstrucrive pulmonary disease ( copd )
Asthma
cystic fibrosis
bronchitis
bronchiectasis
AIDS
Patients who have undergone intubation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: In this group, pneumothorax patients are treated orally for one week by implanting chest tube and taking bromhexine tablets, a product of Aveh Sina Pharmaceutical Company, at a dose of 8 mg once a day. Then the patient is photographed chest and in case of recovery of pneumothorax, the time required for chest tube exit is recorded and examined</i_keyword>
      <i_keyword>Intervention group: In this group, pneumothorax patients are treated by chest tube implantation and N-acetylcysteine, a product of Aveh Sina Pharmaceutical Company, at a dose of 600 mg as a solution in 30cc of water, every 12 hours orally for one week. Take. Then the patient is photographed chest and in case of recovery of pneumothorax, the time required for chest tube exit is recorded and examined</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Normalization of symptoms in chest xray. Timepoint: About a week after starting treatment. Method of measurement: Counting the number of days hospitalized.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Bam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-18</approval_date>
        <contact_name>Ethics Committee of Bam University of Medical Sciences</contact_name>
        <contact_address>Bam - Sardaran Shahid Square - Shahid Rajaei Boulevard Bam Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
