<?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>IRCT20200309046727N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-13</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Investigating the effect of Hijamat  (wet cupping therapy) on acute pulmonary edema due to acute inhalant intoxication with chlorine gas</public_title>
      <acronym></acronym>
      <scientific_title>Explaining “OrameHarreRiyavi”(acute pulmonary edema) and investigating the effect of Hijamat (wet cupping therapy) on acute inhalant intoxication with chlorine gas</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46481</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Because of ethical considerations, this study is a quasi-experimental study, and the conditions, severity and method of intoxication cannot be controlled in advance, Randomization description: In this study,a simple random allocation method using Random Allocation Software (http://mahmoodsaghaie.tripod.com/softwares/randalloc.html) will be used to assign participants to the experimental and control groups.It will be done until reaching the desired sample size in each group(30 people).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute Respiratory Distress Syndrome caused by chlorine gas inhalation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: they receive Hijamat (wet cupping therapy) once between two scapulae, immediately after patient’s visit and after receiving allopathic medical treatment, with the use of a disposable cup for Hijamat (wet cupping therapy) and manual suction for 3 to 5 minutes and creating 10  millimeter skin scratches with a 15 bistoury blade, and then repeating the suction and taking 30 cc blood sampling. Then evaluating the patient’s symptoms 3 times in one hour, one week and one month after Hijamat (wet cupping therapy). Intervention 2: Control group: only receive allopathic medicine treatments at the beginning of the visit and then the evaluating of the patient's symptoms within one hour and one week and one month after the visit.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The study is still undergoing</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>KhaterehAkbariMashak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>PO Box:18155.159, Department of Traditional Medicine, Shahed University, facing the shrine of Imam Khomeini, Persian Gulf Highway(Tehran - Qom)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 4055</telephone>
        <email>Kh.akbari92@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>HasanNamdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>PO Box:18155.159, Department of Traditional Medicine, Shahed University, facing the shrine of Imam Khomeini, Persian Gulf Highway(Tehran - Qom)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 4055</telephone>
        <email>Dr.h.namdar@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Moderate to severe inhalant intoxication with bleaching agent
Age between 2 to 60 years old
Consent to Hijamat (wet cupping therapy)</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of history of previous lung disease such as asthma and chronic obstructive pulmonary disease (COPD)
Existence of history of hypersensitivity syndrome such as urticaria, atopic dermatitis (eczema)
Having sex or menstruation, severe bleeding and any kind of bleeding within the last 12 hours
Consuming foods such as egg, fish, liver, pickle and dairy products during the last 12 hours
Presence of any acute or chronic illnesses in active phase
Taking any anticoagulants drugs such as Aspirin, Warfarin, Plavix and Osvix</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: they receive Hijamat (wet cupping therapy) once between two scapulae, immediately after patient’s visit and after receiving allopathic medical treatment, with the use of a disposable cup for Hijamat (wet cupping therapy) and manual suction for 3 to 5 minutes and creating 10  millimeter skin scratches with a 15 bistoury blade, and then repeating the suction and taking 30 cc blood sampling. Then evaluating the patient’s symptoms 3 times in one hour, one week and one month after Hijamat (wet cupping therapy).</i_keyword>
      <i_keyword>Control group: only receive allopathic medicine treatments at the beginning of the visit and then the evaluating of the patient's symptoms within one hour and one week and one month after the visit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximum respiratory flow. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Peak flow meter device.</prim_outcome>
      <prim_outcome>The level of oxygen saturation of peripheral blood. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Pulse Oximeter device.</prim_outcome>
      <prim_outcome>Respiratory Sounds (wheezes and crackles (rales)). Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Lung sound examination with stethoscope.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Examination and counting per minutes.</prim_outcome>
      <prim_outcome>Puls rate. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Examination and counting per minutes.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Mercury sphygmomanometer device.</prim_outcome>
      <prim_outcome>Gastrointestinal symptoms. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Skin and mucosal irritation symptoms. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Neurological and cognitive symptoms. Timepoint: Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy). Method of measurement: questionnaire.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-17</approval_date>
        <contact_name>Ethics committee of shahedUniversity</contact_name>
        <contact_address>No. 364, Azadi residential complex, ETKA Alley, ShahidJavadAkbari Blvd., AzadiStreet, Tarasht Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
