Home » Trials » SLCTR/2023/008
Comparison of olfactory training, topical corticosteroids and combination therapy for the treatment of post COVID-19 olfactory dysfunction in a tertiary care centre, Sri Lanka; Randomized Controlled trial
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SLCTR Registration Number
SLCTR/2023/008
Date of Registration
The date of last modification
Apr 17, 2023
Scientific Title of Trial
Comparison of olfactory training, topical corticosteroids and combination therapy for the treatment of post COVID-19 olfactory dysfunction in a tertiary care centre, Sri Lanka; Randomized Controlled trial
Public Title of Trial
A clinical trial study to compare treatment options, smell training with essential oils, application of steroid nose drops, application of both the steroid nose drops and smell training and watchful waiting for reduced and altered smell after Covid 19 infection in a tertiary care hospital, Sri Lanka
Disease or Health Condition(s) Studied
Post Covid-19 Olfactory dysfunction
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1290-0737
Any other number(s) assigned to the trial and issuing authority
46/22 - Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayawardanepura
What is the research question being addressed?
What is the most effective treatment out of olfactory training, topical nasal corticosteroids or combination therapy versus watchful waiting for post Covid 19 olfactory dysfunction in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Randomization
a. Method of randomization - Simple randomization 23 each for four groups
b. Unit of randomization - Patients with olfactory dysfunction following COVID 19
c. Method of sequence generation - Computer generated numbers using a software
d. Method of allocation concealment- Open label- No concealment
Intervention I. Olfactory training: Ask to smell 20 seconds of each pure essential oils; citronella, rose, cloves, and eucalyptus twice a day for three months II. Nasal steroids: Two drops of Betamethasone (Probeta) 0.1% nasal drop twice daily for 3 months III. Combination of both the above treatment
Control - Since post covid 19 olfactory training is a novelty, almost all patients get no specific treatment and expect spontaneous recovery
Blinding - Open label
Inclusion criteria
18 years both males and females PCR confirmed COVID 19 patients Has anosmia or hyposmia as symptom following COVID 19 infection confirmed by Quick smell identification test Symptoms persisted for at least more than one month upto 3 months following confirmation of COVID 19
Exclusion criteria
Previous nasal pathologies including sinonasal tumours, chronic rhinosinusitits, allergic rhinitis, pre-existing anosmia or hyposmia Patients with history of allergy to steroids and patients with past history of anaphylaxis Patients who are already on any kind of systemic or topical steroid Pregnant patients Patients with psychiatric disorders, intellectual disabilities and ambulatory disability Patients treated in ICU Clinical history and rhinological examination will be performed at the ENT clinic to exclude patients with other structural rhinological conditions
Primary outcome(s)
|
1.
Quick smell identification test (strip test to identify smell dysfunction which tests 3 different odours) 3 out of 3 score in the QSIT smell identification test |
[ Prior to interventions and 3 months after interventions ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
23 for one arm. Four parallel arms are present in the study. Altogether 92 patients will be allotted.
Countries of recruitment
Sri Lanka
Anticipated start date
2023-05-01
Anticipated end date
2023-08-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2023-02-23
Approval number
46/22
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayawardanepura |
| Institutional Address: | Faculty of Medical Sciences, University of Sri Jayewardenepura Gangodawila, Nugegoda, Sri Lanka |
| Telephone: | Tel.94-11-2758588, |
| Email: | erc.fms@sjp.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. A S R De Alwis
Acting consultant in otorhinolaryngology
Colombo South Teaching Hospital, Kalubowila
0776415041
0715572586
2shashini@gmail.com
Contact Person for Public Queries
Dr. A S R De Alwis
Acting consultant in otorhinolaryngology
Colombo South Teaching Hospital, Kalubowila
0715572586
2shashini@gmail.com
Primary study sponsor/organization
Colombo South Teaching Hospital
B229 Hospital Rd, Dehiwala-Mount Lavinia
0112 763 262
https://www.csth.health.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
