Investigating the Effect of Acupuncture on improving the quality of smell in patients with persistent Olfactory Dysfunction after infection with the COVID-19 Virus
Investigating the impact of Acupuncture on enhancing Olfactory function in patients experiencing persistent Anosmia following COVID-19 infection.
Design
A parallel-group, single-blind, randomized controlled clinical trial was conducted with concealment of random allocation involving 60 patients.
Settings and conduct
The present study is a single-blind randomized clinical trial. The study population comprises patients referred to the ear, nose, and throat clinic of Al-Zahra and Kashani hospitals affiliated with Isfahan University of Medical Sciences who have not experienced any improvement in their sense of smell in the last month following a COVID-19 infection.
Participants/Inclusion and exclusion criteria
Patients with a confirmed diagnosis of COVID-19 in the past, who self-report experiencing Olfactory Dysfunction that has not resolved at least one month after recovery from the disease, are eligible for the study. Individuals with a history of head surgery or trauma, chronic severe Inflammatory Diseases, Degenerative Nasal Conditions, Nasal Allergies, or Abnormal Nasal Anatomy will be excluded from the study.
Intervention groups
Real Acupuncture is used in the test group. Sham Acupuncture is used in the control group.
Main outcome variables
Percentage of people with an improved sense of smell
General information
Reason for update
Acronym
COVID-19
IRCT registration information
IRCT registration number:IRCT20110603006699N6
Registration date:2024-04-30, 1403/02/11
Registration timing:retrospective
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Mehrdad Rogha
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 0352
Email address
rogha@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
2023-05-10, 1402/02/20
Actual recruitment end date
2024-01-10, 1402/10/20
Trial completion date
empty
Scientific title
Investigating the Effect of Acupuncture on improving the quality of smell in patients with persistent Olfactory Dysfunction after infection with the COVID-19 Virus
Public title
Efficacy and safety of Acupuncture in the treatment of post COVID-19 Olfactory Dysfunction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a confirmed diagnosis of COVID-19 in the past who have self-reported Olfactory Disorders.
Within a month of contracting the disease, they show no signs of recovery from their Olfactory Disorder.
Exclusion criteria:
People with a history of any Irritation or Trauma to the Head, Severe Chronic Inflammatory Diseases, Degenerative Diseases (causing Destruction or Disintegration of Nasal Mucosa), and Nasal Allergies.
People with Abnormal Nasal Anatomy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
57
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Random Allocation method will be used. Before beginning the sampling process, we will establish the Randomization sequence and then proceed with Sampling. In this scenario, we will have two vases. The first vase will contain cards numbered from 1 to 60. In vase number 2, there will be 60 non-transparent envelopes containing the desired type of treatment. First, we will randomly select a card from the first vase and an envelope from the second vase and place them in a designated box. In this way, the number removed from pot #1 will receive the treatment that is removed from pot #2. This process will be repeated for all 60 numbers. That is, we will have 60 numbers in the designated box, and each number will correspond to an envelope containing treatment. It should be noted that the type of treatment will be concealed within the envelope until the patients are assigned, and no individual will be aware of the treatment (real acupuncture or placebo acupuncture) given to the patients until their appointment. In fact, the type of intervention inside each envelope is unclear. It is uncertain whether this method involves randomization concealment. In fact, the treatment assigned to the numbers will not be known until the person visits and the envelope is opened for them.
Blinding (investigator's opinion)
Single blinded
Blinding description
In a single-blind study, participants are randomly assigned to two groups. In the first group (test group), real acupuncture is used. Sham acupuncture is used in the second group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-07, 1402/02/17
Ethics committee reference number
IR.MUI.MED.REC.1402.072
Health conditions studied
1
Description of health condition studied
Olfactory Disorder
ICD-10 code
G52
ICD-10 code description
Disorders of olfactory nerve
Primary outcomes
1
Description
Percentage of people with an improved sense of Olfaction
Timepoint
Conduct an olfactory test before starting the intervention and four weeks after the intervention ends.
Method of measurement
Using a short Self-assessment of Olfactory Questionnaire (Self-MOQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After random allocation, an Olfactory test will be conducted in two sessions: the first session (before the intervention) and the second session (four weeks after the end of the intervention). In the intervention group, Real Acupuncture is utilized.
Category
Treatment - Devices
2
Description
Control group: After random allocation, an Olfactory test will be conducted in two sessions: the first session (before the intervention) and the second session (four weeks after the end of the intervention). Sham Acupuncture is used in the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ear, Nose and Throat Clinic, Al-Zahra Hospital, Isfahan University of Medical Sciences
Full name of responsible person
Mostafa Rezaei
Street address
Soffeh Blvd, Isfahan, Isfahan Province.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Ear, Nose and Throat Clinic, Kashani Hospital, Isfahan University of Medical Sciences
Full name of responsible person
Mojtaba Rahimi
Street address
Ayatollah Kashani Street, Ayatollah Kashani Educational and Therapeutic Center, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
GholamReza Asgari
Street address
Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Javad Firouz Vishkasougheh
Position
Non-faculty doctor
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ayatollah Kashani Hospital, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Fax
Email
mohammadj.firouzi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Rogha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3664 0352
Email
rogh@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Rezvani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3664 0352
Email
rezvani@med.mui.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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