<?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>IRCT20200823048495N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-12</date_registration>
      <primary_sponsor>Knowledge Research and Innovation Center, Pakistan (KRIC)</primary_sponsor>
      <public_title>COVID-19 Cure Using Integrative Treatment</public_title>
      <acronym>COVID-19</acronym>
      <scientific_title>The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Single Group, Pretest-Posttest clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52742</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>SARS-COV-2.</hc_freetext>
      <i_freetext>Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms were given the Intervention. Baseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a max of 12 days, 50 ml of Oniater (onion water) once a day for 3 days. Hing  (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of twice a day for a maximum of 12 days. Datseed (date filled with black seeds, once a day for a maximum of 12 days. Use of protein heavy diets, fruits, milk shakes and fresh juices given even beyond 12 days. Use of 70gm of Talbina once per day, which served as high potency oral multivitamins energy diet..</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:
IPD collected for the primary and secondary outcome measures

When:
Starting 6 months after publication

To whom:
Data will be available globally

Conditions:
Data will be accessible to the researchers for the future researches.

Where to obtain:
The researchers can communicate on the following website: https://www.kric.edu.pk
or can email at: health@kric.edu.pk

How to obtain:
Communication from the research center, then send an application for the use of data along with cover letter and resume at: health@kric.edu.pk

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Umber Nawaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9 Noon Avenue, Block C, Muslim Town, Canal Road, Lahore, Punjab, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35440889</telephone>
        <email>umber@kric.edu.pk</email>
        <affiliation>Knowledge Research and Innovation Center, Pakistan (KRIC)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Umber Nawaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9 Noon Avenue, Block C, Muslim Town, Canal Road, Lahore, Punjab, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35440889</telephone>
        <email>umber@kric.edu.pk</email>
        <affiliation>Knowledge Research and Innovation Center, Pakistan (KRIC)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both genders
Aged between 18-80 years
Mild, moderate or severe infection
COVID-19 positive on the basis of symptoms, physical test and lab test</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any tumor or malignancy
Recent surgery
Patient on invasive / non-invasive ventilator (critical)
Taking any other medicine parallel to PAK-20, Oniater and Hing for treatment of COVID-19.
Taking any immunosuppressant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B97.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>SARS-associated coronavirus as the cause of diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms were given the Intervention. Baseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a max of 12 days, 50 ml of Oniater (onion water) once a day for 3 days. Hing  (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of twice a day for a maximum of 12 days. Datseed (date filled with black seeds, once a day for a maximum of 12 days. Use of protein heavy diets, fruits, milk shakes and fresh juices given even beyond 12 days. Use of 70gm of Talbina once per day, which served as high potency oral multivitamins energy diet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: Before intervention and (1,3,5) odd days after intervention. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Cough Scale.</prim_outcome>
      <prim_outcome>Sore Throat. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Sore Throat Scale.</prim_outcome>
      <prim_outcome>Shortness of Breath. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Borg Scale of Short of Breath.</prim_outcome>
      <prim_outcome>Muscle Pain. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Numeric pain rating Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>PCR-RT for COVID-19. Timepoint: Before intervention and 14th day after intervention. Method of measurement: PCR-RT Lab test.</sec_outcome>
      <sec_outcome>Chest X-ray. Timepoint: Before intervention and on 14th day after intervention. Method of measurement: Radiological X-ray findings.</sec_outcome>
      <sec_outcome>10 Second Breath Hold Test. Timepoint: Before intervention and on 14th day after intervention. Method of measurement: Physical 10 Second breath Hold.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>U1111-1262-7419</sec_id>
        <issuing_authority>World Health Organization Universal Trial Number</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Knowledge Research and Innovation Center, Pakistan (KRIC)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-16</approval_date>
        <contact_name>Ethical Research Committee of Knowledge Research and Innovation Center, Pakistan (KRIC)</contact_name>
        <contact_address>9 Noon Avenue, Block C, Muslim Town, Canal Road, Lahore, Punjab, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
