Effect of olfactory training (OT) on olfactory disorders in patients with covid-19
Design
Clinical trial with control group, with parallel groups, single-blind, non-randomized, phase 3 on 78 patients
Settings and conduct
In this clinical trial study, patients with a history of being infected with Covid-19 (PCR positive) referred to Beheshti Hospital's treatment center who stated that they had smell problems for at least 3 months (since the PCR positive result). Randomization will be done - patients into two intervention and control groups -. The severity of the olfactory disorder is the same in both groups. The patients of the intervention group were treated with olfactory rehabilitation sprays for 3 months in the form of sniffing 2 times a day. The patients of the control group were treated with verticosteroid nasal spray 2 times a day for 3 months. Blinding in patients, pain sprays in both groups are completely similar
Participants/Inclusion and exclusion criteria
The main conditions for entering the study:
Patients with a history of being infected with Covid-19 (PCR positive) referring to Shahid Beheshti Health Center who have stated that they have had smell problems for at least 3 months (since the PCR positive result).
The main conditions for not entering the study:
Olfactory disorder caused by head trauma
- History of Parkinson's and Alzheimer's
Nasal polyposis
Merman's rhinosinusitis
History of nose surgery
-Pregnancy
- Other diseases and drugs that cause olfactory disorders.
- History of allergic asthma
Intervention groups
Intervention group: Patients will be treated with Olfactrin's olfactory rehabilitation spray package for 3 months in the form of sniffing twice a day.
Control group: Patients will be treated with corticosteroid nasal spray twice a day for 3 months.
Main outcome variables
Odor detection rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221023056273N1
Registration date:2023-01-02, 1401/10/12
Registration timing:retrospective
Last update:2023-01-02, 1401/10/12
Update count:0
Registration date
2023-01-02, 1401/10/12
Registrant information
Name
Sima Kianipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9399
Email address
sci@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-03, 1401/12/12
Actual recruitment start date
2022-05-05, 1401/02/15
Actual recruitment end date
2022-07-01, 1401/04/10
Trial completion date
2022-10-22, 1401/07/30
Scientific title
ٍEffect of olfactory training on olfactory disorders in patients with Covid -19
Public title
Effect of olfactory training on olfactory disorders caused by covid-19 disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with covid 19 suffering from olfactory disorder referring to medical centers in 2022
Age 20 to 50 years
Exclusion criteria:
Parkinson's and Alzheimer's disease
Olfactory disorder caused by head trauma
Nasal polyposis
Chronic rhinosinusitis
History of illness or nose surgery
Pregnancy
Other diseases and drugs that cause olfactory disorders
Anatomical disorder of the olfactory transmission path detected by PNS CT scan
Getting other viral and bacterial infections at the same time as covid-19
History of asthma and allergies
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
66
Actual sample size reached:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the patients, the sprays used in the two groups will be completely similar.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.201
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Odor Detection Rate
Timepoint
Measuring the rate of olfactory recognition at the beginning of the study and three months after the intervention (receiving olfactory rehabilitation spray or nasal corticosteroid spray)
Method of measurement
The measurement of smell detection will be done through the Iran Smell Identification Test (Iran-SIT).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients will be treated with Olfactrin's olfactory recovery spray package for 3 months in the form of sniffing 2 times a day.
Category
Treatment - Drugs
2
Description
Control group: Patients will be treated with corticosteroid nasal spray twice a day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Amirhossein Ahsani
Street address
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5533 1515
Email
ahsaniaraniamirhossein@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Qutb Ravandi Blvd., University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Amirhosein Ahsani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Doctors Complex, Elahia St., Imam Hossein Square,
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5533 1515
Email
ahsaniaraniamirhossein@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sima Kianipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Doctors Complex, Elahia St., Imam Hossein Square
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5533 1515
Email
simakianipour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sima Kianipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Doctors Complex, Elahia St., Imam Hossein Square,
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5533 1515
Email
simakianipour@gmail.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