<?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>IRCT20221203056699N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-31</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Inhaling Sour Lemon Essential Essence and Level of Consciousness</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Inhaling Sour Lemon Essential Essence and Placebo on the Level of Consciousness in Adult Patients with Mild to Moderate Decreased Level of Consciousness</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Blinding description: The intervention is carried out by a research assistant other than the researcher evaluating the Glasgow coma score before and after the intervention. As a result, the impact assessment researcher is unaware of the type of intervention. Also, as much as possible, the clinical caregiver is kept unaware of the type of intervention. The data analyst will do his work based on the anonymous codes and does not know the type of intervention performed on each code that is a patient. The legal guardian of the patient is fully aware of the study and its purpose, but they are not informed about the type of essential oil (lemon or normal saline).</study_design>
      <phase>2-3</phase>
      <hc_freetext>Decrease Level of Consciousness.</hc_freetext>
      <i_freetext>Intervention 1: intervention will be done within 5 days; 3 times a day and 20 minutes each time (in order to compensate for limitation of the hospitalization time, the frequency of the intervention has been increased to three times). In this regard, for the intervention group, the researcher first placed cotton soaked with 5 drops of 68.2% lemon essential oil from Kashan Barij essence medicine company, in a porous box at a distance of 20-40 cm from the patient and every day at 8:30, 12:30, 16:30 will be used and inhaled. Intervention 2: within 5 days; 3 times a day and 20 minutes each time, for the control group, by the researcher, cotton soaked with 5 drops of normal saline (as a placebo) was placed in a porous box at a distance of 20-40 cm from the patient and every day at 8:30, 12 :30, 16:30 will be used and inhaled.</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 If needed, people can access the study data by contacting the relevant supervisor (Dr. Mahnaz Rakhshan).</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ranjbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Ave, Namazi Square, Hazrat Fatemeh Nursing College</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>zahra_ranjbar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Rakhshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square, Hazrat Fatemeh Nursing College</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>rakhshanm@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with decreased level of consciousness , that at least one week has passed sinse their injury or brain damage.
18 years old and older age
Mild to Moderate level of consciousness disorder (GCS 9-14) due to Head Trauma, Neurological Diseases and Stroke.
Informed consent of the patient or her/his first degree relatives to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with decreased level of consciousness, as a result of receiving sedatives.
Patients with limb paralysis such as Spinal Cord Lesions, due to movement disorders.
Intubated or tracheostomy patients.
Respiratory allergies or allergies to plant extracts.
Problems related to smell and nose injury.
Participating in previous studies receiving Complementary and Alternative Medicine interventions from one week before our intervention.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G96.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of central nervous system, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention will be done within 5 days; 3 times a day and 20 minutes each time (in order to compensate for limitation of the hospitalization time, the frequency of the intervention has been increased to three times). In this regard, for the intervention group, the researcher first placed cotton soaked with 5 drops of 68.2% lemon essential oil from Kashan Barij essence medicine company, in a porous box at a distance of 20-40 cm from the patient and every day at 8:30, 12:30, 16:30 will be used and inhaled.</i_keyword>
      <i_keyword>within 5 days; 3 times a day and 20 minutes each time, for the control group, by the researcher, cotton soaked with 5 drops of normal saline (as a placebo) was placed in a porous box at a distance of 20-40 cm from the patient and every day at 8:30, 12 :30, 16:30 will be used and inhaled.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of Consciousness. Timepoint: The level of consciousness will be measured at the beginning of the study (before the start of the intervention) and every first 5 days, as well as on the eighth day (three days after the last day of the intervention), half an hour before each intervention and 10 minutes after each intervention. Method of measurement: Glasgow coma score.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-31</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand St., University of Medical Sciences central building, 7th floor, Research and Technology Vice-Chancellor Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
