<?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>IRCT20210515051296N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-11</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Effect of cupping on pulmonary symptoms of COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cupping therapy on blood oxygen level in patients with coronavirus 2 (SARS-CoV-2) infection with pulmonary involvement</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>55</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before intervention, each patient selects one of the 55 envelopes that contain the codes 001 to 055, then by having the selected code and using the output table of Block randomization statistical software, it is determined the patient in which group: intervention or controls.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group receive the treatment of COVID-19 according to the protocol of the Ministry of Health, in addition, they should receive cupping therapy using special disposable plastic cups for cupping therapy, for each patient, for 14 days, once a day for 15 to 20 minutes in the back of the chest. Intervention 2: Control group: The control group will be received only the prescribed medications for the treatment of COVID-19 according to the protocol of the Ministry of Health.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahyar Seddighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Buali Sina Medical Center, Buali Street, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3416586165</zip>
        <telephone>+98 28 3333 2930</telephone>
        <email>mahyarseddighi@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahyar Seddighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Buali Sina Medical Center, Buali Street, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413786135</zip>
        <telephone>+98 28 3333 2930</telephone>
        <email>mahyarseddighi@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 18 to 65 years
Resident of Qazvin
Willingness to participate in the research project and complete the consent form
Presence of typical evidence on lung CT-Scan or positive specific RT-PCR test  from oropharyngeal secretions
Presence of clinical criteria for hospitalization (fever above 38 ° C or severe cough or shortness of breath or respiratory rate greater than 24 per minute or oxygen saturation less than 93%)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of coagulation diseases, obesity, deep vein thrombosis
Have a history of vertebral fracture or disc herniation
Patients during pregnancy, lactation, and menstruation
Patients with heart failure
Patients with chronic renal failure
cancer patients
Patients with defective immune system or Patients receiving corticosteroids
Existence of open wound at the site of cupping</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Probable COVID-19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in this group receive the treatment of COVID-19 according to the protocol of the Ministry of Health, in addition, they should receive cupping therapy using special disposable plastic cups for cupping therapy, for each patient, for 14 days, once a day for 15 to 20 minutes in the back of the chest.</i_keyword>
      <i_keyword>Control group: The control group will be received only the prescribed medications for the treatment of COVID-19 according to the protocol of the Ministry of Health.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arterial blood oxygen saturation. Timepoint: At the beginning of the study (before the intervention) and the first to fourteenth days during cupping therapy. Method of measurement: Pulse oximetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscular pain. Timepoint: At the beginning of the study (before the intervention) and then daily for 14 days from the beginning of cupping therapy to the end of cupping therapy. Method of measurement: By asking the patient and the Visual Analog Scale (VAS) score.</sec_outcome>
      <sec_outcome>Headache. Timepoint: At the beginning of the study (before the intervention) and then daily for 14 days from the beginning of cupping therapy to the end of cupping therapy. Method of measurement: By asking the patient and the Visual Analog Scale (VAS) score.</sec_outcome>
      <sec_outcome>Chest pain. Timepoint: At the beginning of the study (before the intervention) and then daily for 14 days from the beginning of cupping therapy to the end of cupping therapy. Method of measurement: By asking the patient and the Visual Analog Scale (VAS) score.</sec_outcome>
      <sec_outcome>Number and severity of cough. Timepoint: At the beginning of the study (before the intervention) and then daily for 14 days from the beginning of cupping therapy to the end of cupping therapy. Method of measurement: By asking the patient and the Visual Analog Scale (VAS) score.</sec_outcome>
      <sec_outcome>Hemoglobin. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: CBC test.</sec_outcome>
      <sec_outcome>ESR. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Sed rate device.</sec_outcome>
      <sec_outcome>LDH. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Device of utoanalyser.</sec_outcome>
      <sec_outcome>RDW. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: CBC test.</sec_outcome>
      <sec_outcome>Platelet. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: CBC test.</sec_outcome>
      <sec_outcome>WBC count. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: CBC test.</sec_outcome>
      <sec_outcome>Lymphocyte Percentage. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: CBC test.</sec_outcome>
      <sec_outcome>Neutrophil Percentage. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: CBC test.</sec_outcome>
      <sec_outcome>CRP. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Agglutination kit.</sec_outcome>
      <sec_outcome>Na. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Flame photometer.</sec_outcome>
      <sec_outcome>K. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Flame photometer.</sec_outcome>
      <sec_outcome>Blood Suger. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Device of utoanalyser.</sec_outcome>
      <sec_outcome>BUN. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Device of utoanalyser.</sec_outcome>
      <sec_outcome>Creatinin. Timepoint: At the beginning of the study (before the intervention) and every other day for 14 days from the beginning of cupping therapy to the end of cupping therapy for 7 days. Method of measurement: Device of utoanalyser.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-08</approval_date>
        <contact_name>Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
