<?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>IRCT20201127049504N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-25</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of acupuncture and warm cupping on clinical manifestations of COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of the efficacy of acupuncture and warm cupping on clinical manifestations of patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52621</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using RAS or Random Allocation Software, they are divided into three groups: intervention groups cupping (B) or acupuncture (A) and the control group (C). Randomization will be done based on Block Randomization with six blocks.
Then, for random allocation, 15 blocks of 6 AABBCC, AABCBC, AACBCB, ABCABC, BABCAC, ACBBCA will be prepared and placed in envelopes. In order of entry and hospitalization of patients, one of the envelopes was selected at random and based on the obtained block, 6 patients will be assigned to three groups, Blinding description: This study is single blind. Researcher who completes questionnaire is blind. The person who evaluates the outcome is unaware of the grouping. Groups A and B and C are available to outcome assessor.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: standard treatment (based on the latest National Diagnostic and Treatment Protocol) + warm cupping: retained cupping  4 cm from each side of theT3 vertebrae for 1 minute, then moving cupping 4 cm from the spinous process of thoracic vertebraes for 5 minutes. Three times a day for 3-7 days (based on patient hospitalization) ; with a medium glass with a mouth diameter of 5 cm and a height of 8 cm, so the suction rate is between 10 and 15 mm. Intervention 2: Intervention group2: standard treatment (based on the latest National Diagnostic and Treatment Protocol) + Acupuncture with standard needling method (without electrical stimulation), once a day for 20 minutes for 3-7 days (based on patient hospitalization). Acupuncture will be done with 25×20 mm needle on acupoints: Lu5, Lu7,LI4, LV3, Ren12, Ren17, ST36. Intervention 3: Control group: standard treatment (based on the latest National Diagnostic and Treatment 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reihane Alipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional Persian Medicine, Vafamanesh St, Heravi Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1668753961</zip>
        <telephone>+98 21 2691 2137</telephone>
        <email>ralipour@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Hooman Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional Persian Medicine, Vafamanesh St, Heravi Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1668753961</zip>
        <telephone>+98 21 2691 2137</telephone>
        <email>amirhoomank@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who need hospitalization according to the guidelines of "National guidelines for the diagnosis and treatment of COVID-19" and for whom medical treatment has been initiated.
And o2 saturation&lt;93%.
Or Chest CT-scan with COVID-19 pattern.
Volunteer to join the trial and sign the informed consent form.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with complications of serious underlying diseases, such as coronary heart disease, chronic obstructive pulmonary disease, obstructive pulmonary disease, meningitis, encephalitis, cirrhosis.
Coagulation disorder and platelets&lt;50,000.
Probability of pulmonary embolism.
Patients with respiratory failure who require mechanical ventilation.
Pregnant or lactating women.
History of allergies and any skin lesions in the area.
Not be volunteer to join the trial and sign the informed consent form.</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: standard treatment (based on the latest National Diagnostic and Treatment Protocol) + warm cupping: retained cupping  4 cm from each side of theT3 vertebrae for 1 minute, then moving cupping 4 cm from the spinous process of thoracic vertebraes for 5 minutes. Three times a day for 3-7 days (based on patient hospitalization) ; with a medium glass with a mouth diameter of 5 cm and a height of 8 cm, so the suction rate is between 10 and 15 mm.</i_keyword>
      <i_keyword>Intervention group2: standard treatment (based on the latest National Diagnostic and Treatment Protocol) + Acupuncture with standard needling method (without electrical stimulation), once a day for 20 minutes for 3-7 days (based on patient hospitalization). Acupuncture will be done with 25×20 mm needle on acupoints: Lu5, Lu7,LI4, LV3, Ren12, Ren17, ST36.</i_keyword>
      <i_keyword>Control group: standard treatment (based on the latest National Diagnostic and Treatment Protocol)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood oxygen saturation. Timepoint: Before intervention and 1,2,3,4,5,6,7 days after intervention. Method of measurement: Pulse oximetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of cough. Timepoint: Before intervention and 1،2،3،4،5،6،7 days after intervention. Method of measurement: CTCAE version 5.</sec_outcome>
      <sec_outcome>Severity of dyspnea. Timepoint: Before intervention and 1،2،3،4،5،6،7 days after intervention. Method of measurement: CTCAE version 5.</sec_outcome>
      <sec_outcome>Chest pain (non cardiac). Timepoint: Before intervention and 1،2،3،4،5،6،7 days after intervention. Method of measurement: CTCAE version 5.</sec_outcome>
      <sec_outcome>Need to oxygen therapy. Timepoint: Before intervention and 1،2،3،4،5،6،7 days after intervention. Method of measurement: CTCAE version 5.</sec_outcome>
      <sec_outcome>Duration of hospital stay. Timepoint: Last day of hospitalization. Method of measurement: Day.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-17</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>1th Floor, Medicine School, Poursina St, Qods St, Enghelab St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
