The effect of olfactory training on anosmia following COVID-19 infection
Design
Patients between the ages of 18-60 years following COVID-19 infection with olfactory dysfunction and a positive serology test who qualify for the study.
Clinical trials are performed on all patients within a specified period of time
Settings and conduct
Patients referred to the olfactory clinic of Amir Alam Hospital in Tehran, where the severity of olfactory disorder is first assessed by SIT test. Patients are then undergo olfactory training for 3 months and then re-evaluated by SIT test.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients between 18-60 years old following COVID-19 infection with olfactory dysfunction and positive serology test
Exclusion Criteria:
History of head trauma, Parkinson's disease, nasal polyposis and other diseases and medications that cause olfactory disorders.
Anatomical and olfactory transmission pathways detected by PNS CT scan.
Negative test for anti-coronavirus serology
Intolerance and poor follow-up during the trial
Death of the patient for any reason
Intervention groups
Intervention group 1: Evaluation of the effectiveness of olfactory rehabilitation with different aromas as a therapeutic method and helping patients with olfactory disorders following COVID-19
Intervention group 2: Evaluation of the effectiveness of olfactory rehabilitation with different aromas as a treatment and aid to patients with olfactory disorders following COVID-19 and also comparison of the effectiveness of rehabilitation start time in patients (3 months vs. 6 months)
Main outcome variables
Improve the sense of smell and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200629047953N1
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Mohammadsadegh Zabihidan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 8353
Email address
sina_zabihidan@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of olfactory training on anosmia following COVID-19 infection
Public title
Effect of olfactory training on anosmia of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Smell disorders caused by COVID-19 during Coronavirus pandemia
Positive Serology of COVID-19
Considering that the numbers of patients who have been suffering from olfactory disorder due to corona pandemic for 3 months and have inclusion criteria of the study, and according to statistical estimates, at least 40 patients are required, all patients who refer to the clinic are selected. First, the olfactory recognition test is tested with the smell test booklet of Danesh Bonyan Company (Iran Smell Identification Test). The initial result is recorded. Then, they will be treated by the package of Olfactrin Oral Rehabilitation Sprays for 3 months by inhaling this package twice a day. The odor test is performed again and the result is recorded. Also, the second group or the control group are patients who have had olfactory disorder for more than 6 months and no rehabilitation intervention has been performed in the last three months.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnics committee of Tehran University of Medical Sciences
Street address
Amir A'lam Hospital, Saadi St., Darvazeh Dowlat
City
Tehran
Province
Tehran
Postal code
6511111457
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1399.017
Health conditions studied
1
Description of health condition studied
Loss of smell, Olfactory Rehabilitation
ICD-10 code
R43.0
ICD-10 code description
Anosmia
Primary outcomes
1
Description
Score of Smell Identification Test
Timepoint
Measure theSIT test at the beginning of the study and 90 days after the onset of olfactory rehabilitation
Method of measurement
Iranian SIT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who have had an olfactory disorder for more than 3 months, are treated with Olfactrin Odor Rehabilitation Spray Package by smelling these sprays twice a day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Patients who have had an olfactory disorder for more than 6 months, and have not undergone any rehabilitation intervention in the past three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir A'lam Hospital
Full name of responsible person
Mohammad Reza Firoozifar
Street address
North Saadi St., Enqelab St., (Darvzeh Dowlat)
City
Tehran
Province
Tehran
Postal code
65111 11457
Phone
+98 21 6634 3352
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh Basti
Street address
Pour Sina St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 6640 5357
Email
deanmed@tums.ac.ir
Web page address
http://medicine.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadsadegh Zabihidan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi St., Darvazeh Dowlat
City
Tehran
Province
Tehran
Postal code
65111 11457
Phone
+98 21 6634 3352
Email
Sina_Zabihidan@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadsadegh Zabihidan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
1st Floor, No. 18, Ensafimoqadam St., Azarbayejan St.
City
Tehran
Province
Tehran
Postal code
1319784915
Phone
+98 71 3630 8353
Fax
Email
sina_zabihidan@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadsadegh Zabihidan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
1st Floor, No. 18, Ensafimoqadam St., Azarbayejan St.
City
Tehran
Province
Tehran
Postal code
1319784915
Phone
+98 71 3630 8353
Fax
Email
sina_zabihidan@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available