<?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>IRCT20181030041504N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-08</date_registration>
      <primary_sponsor>Sirjan Faculty of Medical Science</primary_sponsor>
      <public_title>Evaluation of the combined effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on treatment, clinical symptoms of non-hospitalization and hospitalization patients with symptomatic COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on treatment, clinical symptoms of non-hospitalization and hospitalization patients with symptomatic COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51482</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the quadruple block method (Block Randomization). Random allocation software will be used for this purpose. We prepare two sheets of paper. On a sheet we write the letter I meaning "Intervention" and on a sheet the letter S means "Standard treatment". Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the leaflets will be randomly taken out and based on this extracted leaflet will be assigned to one of the two intervention groups. It should be noted that the pulled out sheets will not be returned to the drawer until all four sheets have been pulled out. After accidentally pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached, Blinding description: Participant, Evaluator, Data analyst, Data safety and Monitoring committee.</study_design>
      <phase>3</phase>
      <hc_freetext>covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: non-hospitalization patients with symptomatic COVID-19 received 1. Artemisia annua - Artemisinin ( Manufactured by Longlifenutri)150 mg every 24 hours 2. Dose of 1 g of vitamin C (Manufactured by Daroupakhsh) intravenous vitamin (2 ampoules of 500 mg in 250 cc of sodium chloride serum for 30 minutes) every 24 hours 3. Dose of 5 cc of noscapine ( Manufactured by Faran Shimi) each Eight hours 4. 500 mg dose of hesperidin (Manufactured by Swanson) every 24 hours 5. Resveratrol 500 mg (Manufactured by A Squard)  every 24 hours 6. NAC 600 mg ( Manufactured by Osvah ) every 12 hours . The duration of treatment is estimated at ten days. Supplements are taken orally and vitamin C is given to patients as an injection. Intervention 2: Control group: non-hospitalization patients with symptomatic COVID-19 Protocol of the Ministry of Health. Intervention 3: Intervention group: hospitalization patients with symptomatic COVID-19  received 1. Artemisia annua - Artemisinin ( Manufactured by Longlifenutri)150 mg every 12hours 2. Dose of 1 g of vitamin C (Manufactured by Daroupakhsh) intravenous vitamin (2 ampoules of 500 mg in 250 cc of sodium chloride serum for 30 minutes) every 12 hours 3. Dose of 5 cc of noscapine ( Manufactured by Faran Shimi) each Eight hours 4. 500 mg dose of hesperidin (Manufactured by Swanson) every 24 hours 5. Resveratrol 500 mg (Manufactured by A Squard)  every 24 hours 6. NAC 600 mg ( Manufactured by Osvah ) every 12 hours .  The duration of treatment is estimated at ten days.Supplements are taken orally and vitamin C is given to patients as an injection. Intervention 4: Control group:  hospitalization patients with symptomatic COVID-19 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Main outcome data, statistical analysis, final report, informed consent form

When:
6 months after publish the results

To whom:
Academic researchers

Conditions:
Master of Medical Sciences
PhD in Medical Sciences
specialist
Contribute to the advancement of science

Where to obtain:
Email m.mohamadpour2817@yahoo.com
Contact number: 09120031782
Dr. Masoomeh Mohamadpour - Tehran

How to obtain:
48-72 hours after sending the email request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Ali,Amjadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Seyyed Jamaledin Asad Abadi Blvd - Parks of Traffic</address>
        <city>Sirjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7816916338</zip>
        <telephone>+98 34 4234 0640</telephone>
        <email>Aamjadi50@yahoo.com</email>
        <affiliation>Sirjan Faculty of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Masoomeh Mohamadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 16, Gisha Ave</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1448643643</zip>
        <telephone>+98 21 8827 5219</telephone>
        <email>m.mohamadpour2817@yahoo.com</email>
        <affiliation>Rayan Research Company</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>COVID-19 virus infection by RT-PCR in non-hospitalization and hospitalization patients
G6PD sufficient  in non-hospitalization and hospitalization patients
Lack of clinical response to routine outpatient treatment  in non-hospitalization and hospitalization patients
Clinical symptoms (fever, cough, myalgia, shortness of breath, digestive problems)  in non-hospitalization and hospitalization patients
Age over 12 years  in non-hospitalization and hospitalization patients
Patient satisfaction  in non-hospitalization and hospitalization patients
Lymphocytes less than 15%, respiratory distress, lung involvement on CT scan, oxygen level less than 93%, unstable vital signs, severe gastrointestinal symptoms and oral intolerance, underlying disease Except for exclusion cases hospitalization patients</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to oral supplements and high doses of vitamin C
Reluctance to continue participating in the trial for any reason
Patients admitted to the intensive care unit (ICU) (patients who have been admitted to the ICU since admission)
Pregnant and lactating lady
Patients with seizures
Dialysis patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>RA01.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe Acute Respiratory Syndrome coronavirus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: non-hospitalization patients with symptomatic COVID-19 received 1. Artemisia annua - Artemisinin ( Manufactured by Longlifenutri)150 mg every 24 hours 2. Dose of 1 g of vitamin C (Manufactured by Daroupakhsh) intravenous vitamin (2 ampoules of 500 mg in 250 cc of sodium chloride serum for 30 minutes) every 24 hours 3. Dose of 5 cc of noscapine ( Manufactured by Faran Shimi) each Eight hours 4. 500 mg dose of hesperidin (Manufactured by Swanson) every 24 hours 5. Resveratrol 500 mg (Manufactured by A Squard)  every 24 hours 6. NAC 600 mg ( Manufactured by Osvah ) every 12 hours . The duration of treatment is estimated at ten days. Supplements are taken orally and vitamin C is given to patients as an injection</i_keyword>
      <i_keyword>Control group: non-hospitalization patients with symptomatic COVID-19 Protocol of the Ministry of Health</i_keyword>
      <i_keyword>Intervention group: hospitalization patients with symptomatic COVID-19  received 1. Artemisia annua - Artemisinin ( Manufactured by Longlifenutri)150 mg every 12hours 2. Dose of 1 g of vitamin C (Manufactured by Daroupakhsh) intravenous vitamin (2 ampoules of 500 mg in 250 cc of sodium chloride serum for 30 minutes) every 12 hours 3. Dose of 5 cc of noscapine ( Manufactured by Faran Shimi) each Eight hours 4. 500 mg dose of hesperidin (Manufactured by Swanson) every 24 hours 5. Resveratrol 500 mg (Manufactured by A Squard)  every 24 hours 6. NAC 600 mg ( Manufactured by Osvah ) every 12 hours .  The duration of treatment is estimated at ten days.Supplements are taken orally and vitamin C is given to patients as an injection</i_keyword>
      <i_keyword>Control group:  hospitalization patients with symptomatic COVID-19 Protocol of the Ministry of Health</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>LDH. Timepoint: Before the intervention and ten days after the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>CBC diff. Timepoint: Before the intervention and ten days after the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Na/K/Ca. Timepoint: Before the intervention and ten days after the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>CRP. Timepoint: Before the intervention and ten days after the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>ESR1. Timepoint: Before the intervention and ten days after the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Weakness and nausea. Timepoint: Before the intervention and ten days after the intervention. Method of measurement: Check List.</prim_outcome>
      <prim_outcome>Lung  involvement. Timepoint: Before the intervention and ten days after the intervention. Method of measurement: CT-Scan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determination of the effect of Hesperidin,Artemisinin- Artemisia annua, Noscapine, N-acetylcysteine, Resveratrol supplements and high dose of vitamin C on on oxygen. Timepoint: 10 day. Method of measurement: Pulse Oximeter.</sec_outcome>
      <sec_outcome>General condition of people and vitality after treatment. Timepoint: 10 day. Method of measurement: Examination and history.</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>Sirjan Faculty of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-07</approval_date>
        <contact_name>sirjan faculty of medical science</contact_name>
        <contact_address>sirjan - Seyyed Jamaledin Asad Abadi Blvd - Parks of Traffic - Sirjan University of Medical Sciences sirjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
