<?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>IRCT20150916024047N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-16</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect  extract of violet on fever  patient with covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of aqueous extract of violet on fever in patient with covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59676</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 52 patients were selected by convenience sampling method and were randomly assigned to one of the two experimental groups (A) and control (B). According to the 6 possible modes of placing letters in quadruple blocks, these blocks are numbered with numbers from one to six (AABB1- ABBA2 - BABA3 - BBAA4 -ABAB5 ABAB6) then using Random Allocation Software 2.0 one of the numbers up to Six are randomly selected for 13 times. The four blocks are placed in 13 opaque numbered envelopes according to a random selection sequence, and these envelopes are sealed by a person outside the research team, respectively, and the patients are assigned to the relevant groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19 Patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the experimental group, after recording the temperature and receiving acetaminophen ampoules, one gram intravenous infusion for 15 minutes and using 5 cc of violets barij extract prepared from the blue extract of Violets flower) with Product registration code no. 6599807159453166 from Bari j Essence Company, in people whose sweetness of syrup stimulates the throat due to red sugar, they can take the dose in half of the water supply. Lukewarm dissolves and drinks slowly will be used.Temperatures will be recorded at 30, 60 minutes and the end of 4 hours.The patients' falloff will continue for three days and in case of fever in the experimental group, in addition to acetaminophen injection, violet syrup will be given to patients every 8 hours up to three days and the patient's temperature will be recorded every 6 hours and in case of no fever, violet syrup will be discontinued. Intervention 2: The control group will receive routine measures including receiving 1g acetaminophen injection as intravenous infusion at 100 cc normal saline for 15 minutes. Follow-up will continue for up to 3 days and the patient's temperature will be recorded every 6 hours.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Patient name information will be kept confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>DR.H. jafary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery., Vesal., west Amir mazandarani,</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>009833350602</telephone>
        <email>hedayat2003@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.Hedayat.jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal,  Amir mazandarani</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>0981133350602</telephone>
        <email>hedayat2003@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of covid 19 with positive PCR
Temperature between 38.3 to 40 ° C
Having a fever from the time of admission to 10 days
Complete patient consciousness
Lack of any sensitivity to herbal medicines,
Not receiving and not using Other help methods to reduce fever in 4 hours before</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity to violet syrup
Unwillingness to cooperate
Not being pregnant
Seizures
History of head trauma and brain tumor and history of brain surgery due to possible hypothalamus disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID19, virus identified</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>Intervention group: In the experimental group, after recording the temperature and receiving acetaminophen ampoules, one gram intravenous infusion for 15 minutes and using 5 cc of violets barij extract prepared from the blue extract of Violets flower) with Product registration code no. 6599807159453166 from Bari j Essence Company, in people whose sweetness of syrup stimulates the throat due to red sugar, they can take the dose in half of the water supply. Lukewarm dissolves and drinks slowly will be used.Temperatures will be recorded at 30, 60 minutes and the end of 4 hours.The patients' falloff will continue for three days and in case of fever in the experimental group, in addition to acetaminophen injection, violet syrup will be given to patients every 8 hours up to three days and the patient's temperature will be recorded every 6 hours and in case of no fever, violet syrup will be discontinued.</i_keyword>
      <i_keyword>The control group will receive routine measures including receiving 1g acetaminophen injection as intravenous infusion at 100 cc normal saline for 15 minutes. Follow-up will continue for up to 3 days and the patient's temperature will be recorded every 6 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: Q6h - 3day. Method of measurement: Before the intervention, patients' temperature is recorded with MICROLAB digital thermometer.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-16</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing, Midwifery., Vesal., Amir Mazandarani Stree., Sari t Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
