<?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>IRCT20210202050231N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-08</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of vanilla essential oil with eucalyptus essential oil on the return of olfactory sense in COVID-19 patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of vanilla essential oil with eucalyptus essential oil on the return of olfactory sense in COVID-19 patients with olfactory dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54081</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the available people, randomly blocked blocks with a volume of "6 random blocks" will be randomly assigned to one of the intervention and control groups, the list of blocks and their random order by the statistical consultant and based on Proc PLAN in software The SAS software will be identified and made available to the patient selector.In the proc command we will defined the total number of required samples, number of blocks, number of groups, code related to arm. so, output of SAS includes the code of participants in blocks with size 6, in each block, 2 samples regarding to each group are randomly distributed, Blinding description: Participants in the control group will receive a placebo.
Statistical consultants are unaware of intervention and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients in this group have olfactory stimulation (sniffing 100% pure eucalyptus essential oil from the French company seven star) in plastic perfume bottles of 2.5 ml with the label "Do not eat"  How to use: irritating smell for a week, every day 6 times (within 4 hours) after washing your nose with saline  0.9 percent. Intervention 2: Intervention group 2: Patients in this group have olfactory stimulation (smelling 100% pure vanilla essential oil from the French company sevenstar) in 2.5 ml plastic perfume containers labeled "Do not eat"  How to use: Odor stimulation will be done 6 times a day (4 hours apart) after rinsing your nose with 0.9% rinsing serum. Intervention 3: Control group: Patients in this group will receive placebo (plastic perfume containers containing 2.5 ml of water labeled "Do not eat" for 6 weeks (every 4 hours) after rinsing the nose with serum Wash percentage).</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:
All study information except personal information of the participants

When:
A year after the publication

To whom:
For researchers working in academic and scientific institutions

Conditions:
To extract more findings

Where to obtain:
By e-mail after the permission of the University of Medical Sciences

How to obtain:
Obtain permission from Zanjan University of Medical Sciences, email it to the person in charge of research, receive information

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad ali Yadegary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8241</telephone>
        <email>ma.yadegary@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad ali Yadegary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8241</telephone>
        <email>ma.yadegary@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent to participate in the study  -
Have a positive PCR test
They did not experience any signs of decreased olfactory and taste sensation at least 2 weeks before the onset of the first Covid-19 demonstrations.
-Living in the city
Non-smoker</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- People with certain underlying diseases (such as asthma and history of allergies, Parkinson's, Alzheimer's, severe eating disorders, acute rhinitis, acute sinusitis, nasal congestion, for example, after rhinoplasty, traumatic nerve damage and.
Having other viral and bacterial infections at the same time as Covid-19
- People who deal with thick odors in their job, such as working with paint or acid.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified site (B34.2)Coronavirus as the cause of diseases classified to other chapters (B97.2)Severe acute respiratory syndrome [SARS], unspecified (U04.9)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Patients in this group have olfactory stimulation (sniffing 100% pure eucalyptus essential oil from the French company seven star) in plastic perfume bottles of 2.5 ml with the label "Do not eat"  How to use: irritating smell for a week, every day 6 times (within 4 hours) after washing your nose with saline  0.9 percent.</i_keyword>
      <i_keyword>Intervention group 2: Patients in this group have olfactory stimulation (smelling 100% pure vanilla essential oil from the French company sevenstar) in 2.5 ml plastic perfume containers labeled "Do not eat"  How to use: Odor stimulation will be done 6 times a day (4 hours apart) after rinsing your nose with 0.9% rinsing serum.</i_keyword>
      <i_keyword>Control group: Patients in this group will receive placebo (plastic perfume containers containing 2.5 ml of water labeled "Do not eat" for 6 weeks (every 4 hours) after rinsing the nose with serum Wash percentage)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The result of the olfactory test is reported as a number from zero to 24 and indicates the function of the sense of smell in the range of normal and mild normosemia, anosmia, hyposemia (microsaemia). Timepoint: Before intervention, one week after intervention, two weeks after intervention. Method of measurement: University of Pennsylvania Odor Detection Test (UPSIT).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-24</approval_date>
        <contact_name>Ethics committee of zanjan university of medical sciences</contact_name>
        <contact_address>Professor Yousef Sabouti Blvd., Zanjan University of Medical Sciences zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
