<?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>IRCT20200428047229N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of cupping on respiratory symptoms of COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of cupping therapy on respiratory symptoms of patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51516</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first due to the inclusion criteria, infectious diseases specialist diagnosis, and positive PCR test, and Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving cupping and control group (Assignment). Then based on blocks and allocation sequences cupping therapy will be given to patients. This is an open-label study and blinding will not happen.</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 5 days, once a day for 15 to 20 minutes in the back of the chest (3 glasses on each side). Intervention 2: Control group: Patients in this group receive medication for COVID-19 according to the Ministry of Health protocol.</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>Hanieh Tahermohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>dr.hmohammadi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Tansaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8 Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>Tansaz_mojgan@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18 to 60 years
Diagnosis confirmation by the cooperative infectious disease specialist in the project
Patient's consent to participate in the project
With inpatient clinical criteria (fever above 38° C  or severe cough or shortness of breath or respiratory rate more than 24 per minute or oxygen saturation lower than 93%)
Positive PCR</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Current incidence of coagulopathy, obesity, deep vein thrombosis, vertebral fracture or herniated disc
Need for current hospitalization in ICU
Pregnancy
Breastfeeding
Hearth failure
Chronic renal failure
Receive chemotherapy
Receive corticosteroids
Immune deficiency
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>COVID-19, virus identified</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 5 days, once a day for 15 to 20 minutes in the back of the chest (3 glasses on each side).</i_keyword>
      <i_keyword>Control group: Patients in this group receive medication for COVID-19 according to the Ministry of Health protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyspnea. Timepoint: At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of cupping. Method of measurement: By using a pulse oximeter and asking the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fever. Timepoint: At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the medical beer. Method of measurement: Mercury thermometer (oral).</sec_outcome>
      <sec_outcome>Muscular pain. Timepoint: At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the cupping. Method of measurement: By asking the patient and the Visual Analog Scale (VAS) score.</sec_outcome>
      <sec_outcome>Dry cough. Timepoint: At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the cupping. Method of measurement: By asking the patient.</sec_outcome>
      <sec_outcome>ESR. Timepoint: At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping. Method of measurement: Sed rate device.</sec_outcome>
      <sec_outcome>CRP. Timepoint: At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping. Method of measurement: Agglutination kit.</sec_outcome>
      <sec_outcome>Cell blood count. Timepoint: At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping. Method of measurement: Cell Counter device.</sec_outcome>
      <sec_outcome>Chest X-ray. Timepoint: At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping. Method of measurement: Radiology set.</sec_outcome>
      <sec_outcome>Chest CT scan. Timepoint: At the beginning of the study (before the start of the intervention) and on the 5th day, if requested by the treating physician, it will be recorded. Method of measurement: CT scan set.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-08</approval_date>
        <contact_name>Ethics committee of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Scie</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
