<?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>IRCT20200330046899N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-17</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of herbal capsule in  COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the efficacy of herbal capsule in COVID-19 patients in a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is used in this study. The treatment assignment is in a 1:1 ratio, and there are two groups, then, the block size is chosen 4. Possible balanced combinations are calculated with 2 subjects in control and 2 subjects in the intervention group (Six possibilities). In each 4 block size, two patients will be assigned to the intervention (capsule) group and two patients will be assigned to the control group. To allocate all participants in the two groups, the blocks are randomly selected.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 50 patients receive routine interventions according to the instructions of the Ministry of Health for 1 weeks. Intervention 2: Intervention group: 50 patients receive herbal treatment including  capsule (Lyophilized powder from hydroalcoholic 70% extracts of Punica granatum L., Rheum palmatum L.,  Glycyrrhiza glabra L., and seed powder of Nigella sativa L.) 2 times a day with routine interventions based on the instructions of the Ministry of Health for 1 weeks.</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:
All results will be shared with identified individuals

When:
Start the access period from 6 months after printing results

To whom:
Academic researchers can access data

Conditions:
For use in review articles, and modeling can be used in other studies.

Where to obtain:
for data accessing, send an email to mseteyeshmail@gmail.com. Or call 09133950546

How to obtain:
It will be done through coordination with the executor or the vice chancellor for research of the university and after the identification of the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hamid Aboosaeidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Highway, Afzalipoor Hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۶۹۱۳۹۱۱</zip>
        <telephone>+98 34 3132 8000</telephone>
        <email>Habousaidi@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Setayesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Alley 12, Shafa Street, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618745853</zip>
        <telephone>+98 34 3212 4069</telephone>
        <email>msetayeshmail@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who require hospitalization based on national guidelines for diagnosis and treatment of COVID-19 and need to start drugs.
18 to 75 years of age for both sexes
The patient's ability to fill out an informed consent form to enter the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
History of allergy to any of the components of the herbal product
The patient's inability to take oral form
The patients with serious underlying disease at the same time, including high blood pressure, heart disease, lung disease, cerebral disease, diabetes.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19</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>Control group: 50 patients receive routine interventions according to the instructions of the Ministry of Health for 1 weeks</i_keyword>
      <i_keyword>Intervention group: 50 patients receive herbal treatment including  capsule (Lyophilized powder from hydroalcoholic 70% extracts of Punica granatum L., Rheum palmatum L.,  Glycyrrhiza glabra L., and seed powder of Nigella sativa L.) 2 times a day with routine interventions based on the instructions of the Ministry of Health for 1 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Temperature. Timepoint: 0-1-2-3-4-5-6-7 days after starting intervention. Method of measurement: Mercury thermometer.</prim_outcome>
      <prim_outcome>Cough severity. Timepoint: 1th and 7th dady after starting intervention. Method of measurement: cough severity score 1-4.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: 0-1-2-3-4-5-6-7 days after starting intervention. Method of measurement: Counting the number of breaths per minute.</prim_outcome>
      <prim_outcome>Dyspnea severity. Timepoint: 0-1-2-3-4-5-6-7 days after starting intervention. Method of measurement: Dyspnea severity score 1-4.</prim_outcome>
      <prim_outcome>O2 saturation percentage. Timepoint: pulse oximetry at baseline, 1-2-3-4-5-6-7 days after starting intervention. Method of measurement: pulse oximeter.</prim_outcome>
      <prim_outcome>White blood cell count. Timepoint: baseline and  day 7 after starting intervention. Method of measurement: WBC counting under the microscope.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-13</approval_date>
        <contact_name>Kerman University of Medical Science</contact_name>
        <contact_address>Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
