UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043537 |
|---|---|
| Receipt number | R000049715 |
| Scientific Title | Post COVID-19 Anosmia treatments |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2021/03/05 21:56:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Post COVID-19 Anosmia
Acronym
Anosmia
Scientific Title
Post COVID-19 Anosmia treatments
Scientific Title:Acronym
Anosmia treatments
Region
| Africa |
Condition
Condition
Anosmia
Classification by specialty
| Medicine in general | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the role of the topical corticosteroid, antihistamines, nasal spray in the treatment of post-COVID-19 anosmia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anosmia improvement that was measured by Butanol threshold test and discrimination test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination of local corticosteroids and antihistamines nasal spray
Interventions/Control_2
Local corticosteroids nasal spray
Interventions/Control_3
Antihistamines nasal spray
Interventions/Control_4
Normal saline 0.2%
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All adults with post-COVID-19 smell dysfunction
Key exclusion criteria
We excluded patients who already used nasal or systemic steroids or with previous chronic rhinological pathologies, patients with anosmia improved before COVID-19 recovery, pregnant women, or patients who did not complete the follow-up period
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Asmaa |
| Middle name | Salah. |
| Last name | Mohamed |
Organization
Derya university
Division name
Clinical pharmacy
Zip code
61516
Address
Minia, Egypt
TEL
01066953443
asmaa.elsaddory@yahoo.com
Public contact
Name of contact person
| 1st name | Hosam |
| Middle name | Mohammad |
| Last name | Ahmad |
Organization
Egypt Ministry of Health and population
Division name
Internal Medicine and biomedical chemistry
Zip code
61516
Address
Minia, Egypt
TEL
01000638308
Homepage URL
hosam.refaei@yahoo.com
Sponsor or person
Institute
Derya university, Minia university
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Deraya university
Address
Plot No 3 Ard El Gameaat, New Minya, Minya, Egypt
Tel
16283
commuincation.center@deraya.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
"Derya University, Minia university hospital"
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049715
