<?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>IRCT20120109008665N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-31</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of Turmeric and Ginger on the clinical manifestations and laboratory findings of patients with Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Turmeric and Ginger on the clinical manifestations and laboratory findings of patients with Covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58418</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Assignment of samples (to two experimental groups and one control group) will be done by simple random method using sealed envelopes. In this method, the letter T represents the turmeric group, the letter G represents the ginger group and the letter C represents the control group, Blinding description: Participants are randomly assigned to groups using sealed envelopes containing the letters T, G, and C, each of which identifies intervention or control groups. Because drugs will be identified in similar, opaque, letter-only bottles, and patients will be treated on an outpatient basis at home, participants, the outcome assessor, and the data analyst are unaware of the allocation of individuals to experimentals and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (turmeric) receives 3 tablets of 500 mg of turmeric (curcuma) daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company. Intervention 2: Intervention group: Group B (Vomigone) receives 3 tablets of 500 mg of ginger (Vomigone) daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company. Intervention 3: Control group: Group C receives 3 tablets of 500 mg of placebo daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company and contain compounds of polyvinyl pyrrolidone (PVP), microcrystalline cellulose (Avicel), starch and colorless.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Babamohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4192</telephone>
        <email>babamohammady2007@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Babamohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4192</telephone>
        <email>babamohammady2007@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years or older
Definitive diagnosis of Covid-19 disease (positive PCR, CT scan)
Absence of chronic hepatitis
Absence of cirrhosis
Absence of cholestatic liver disease
Absence of gallbladder inflammation
Absence of peptic ulcers
Lack of sensitivity to ginger
Lack of sensitivity to turmeric
Absence of women during pregnancy and lactation
Do not take anti-inflammatory drugs such as Colchicine and Actemra</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue participating in research</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A (turmeric) receives 3 tablets of 500 mg of turmeric (curcuma) daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company.</i_keyword>
      <i_keyword>Intervention group: Group B (Vomigone) receives 3 tablets of 500 mg of ginger (Vomigone) daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company.</i_keyword>
      <i_keyword>Control group: Group C receives 3 tablets of 500 mg of placebo daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company and contain compounds of polyvinyl pyrrolidone (PVP), microcrystalline cellulose (Avicel), starch and colorless.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: From the beginning of the intervention until the fifth day. Method of measurement: Fever will be measured using a mercury thermometer.</prim_outcome>
      <prim_outcome>Cough. Timepoint: From the beginning of the intervention until the fifth day. Method of measurement: Severity of cough will be measured using the visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: From the beginning of the intervention until the fifth day. Method of measurement: Severity of fatigue will be measured using the visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Sore throat. Timepoint: From the beginning of the intervention until the fifth day. Method of measurement: Severity of sore throat will be measured using the visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Nasal congestion. Timepoint: From the beginning of the intervention until the fifth day. Method of measurement: Severity of nasal congestion will be measured using the visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Diarrhea. Timepoint: From the beginning of the intervention until the fifth day. Method of measurement: The severity of diarrhea will be assessed by the number of times a day.</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: From the beginning of the intervention until the fifth day. Method of measurement: Severity of dyspnea will be measured using the visual analog scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complete blood count (CBC). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention). Method of measurement: Using the relevant laboratory kits.</sec_outcome>
      <sec_outcome>Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention). Method of measurement: Using the relevant laboratory kits.</sec_outcome>
      <sec_outcome>C-reactive protein (CRP). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention). Method of measurement: Using the relevant laboratory kits.</sec_outcome>
      <sec_outcome>Lactate dehydrogenase (LDH). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention). Method of measurement: Using the relevant laboratory kits.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-24</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
