UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045185 |
|---|---|
| Receipt number | R000051620 |
| Scientific Title | "ADDITIONAL VALUE" OF NASAL THERAPY IN STANDARD THERAPY FOR COVID-19 PATIENTS WITH OLFACTORY DISORDERS: A Preliminary Randomized Controlled Clinical Trial |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2021/08/18 14:15:46 |
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Basic information
Public title
"ADDITIONAL VALUE" OF NASAL THERAPY IN STANDARD THERAPY FOR COVID-19 PATIENTS WITH OLFACTORY DISORDERS:
A Preliminary Randomized Controlled Clinical Trial
Acronym
"ADDITIONAL VALUE" OF NASAL THERAPY IN STANDARD THERAPY FOR COVID-19 PATIENTS WITH OLFACTORY DISORDERS:
A Preliminary Randomized Controlled Clinical Trial
Scientific Title
"ADDITIONAL VALUE" OF NASAL THERAPY IN STANDARD THERAPY FOR COVID-19 PATIENTS WITH OLFACTORY DISORDERS:
A Preliminary Randomized Controlled Clinical Trial
Scientific Title:Acronym
"ADDITIONAL VALUE" OF NASAL THERAPY IN STANDARD THERAPY FOR COVID-19 PATIENTS WITH OLFACTORY DISORDERS:
A Preliminary Randomized Controlled Clinical Trial
Region
| Asia(except Japan) |
Condition
Condition
olfactory disorder in COVID-19
Classification by specialty
| Medicine in general | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical presentation of olfactory disorders in COVID-19 based on the alcohol sniff test (AST) and the intravenous olfaction test (IOT) and the effectiveness of the nasal therapy protocol as an adjunct to standard therapy in COVID-19 patients with olfactory disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of olfactory disorders both subjective (visual analog score) and objective by Alcohol sniff test and Intravenous olfaction test results after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
COVID standar Therapy for 2 weeks
Interventions/Control_2
COVID standar Therapy and nasal treatment (mometasone nasal spray 2dd2 spray, normosaline nasal irrigation 2dd30 cc both nostrils, oxymethazolin 0,5% nasa spray 1dd2 spray before bedtime, aromatic vaporub 1dd1 on neck and chest before bedtime) for 2 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Confirmed Sars-COV2 PCR positive with mild or moderate symptomps
2. Impaired Alcohol Swab test result
3. Cooperative
Key exclusion criteria
1. Cognitive and conciousness impairment
2. Severe dyspnea and unstable vital sign
3. History of olfactory and taste disturbance before COVID
4. History of chronic rhinosinusitis and severe head trauma
5. History of routine use of steroid intranasal, decongestan before COVID-19
6. History of skin and vascular problem
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | indra |
| Middle name | parmaditya |
| Last name | pamungkas |
Organization
ORL-HNS Departement CIpto Mangunkusumo General Hospital
Division name
Oncology-Rhinology
Zip code
10430
Address
Jl Diponegoro 71 Senen Central Jakarta
TEL
6281314319179
indraparmaditya@gmail.com
Public contact
Name of contact person
| 1st name | indra |
| Middle name | parmaditya |
| Last name | pamungkas |
Organization
ORL-HNS Departement CIpto Mangunkusumo General Hospital
Division name
Oncology-Rhinology
Zip code
10430
Address
Jl Diponegoro 71 Senen Central Jakarta
TEL
6281314319179
Homepage URL
indraparmaditya@gmail.com
Sponsor or person
Institute
there were no sponsors available
Institute
Department
Personal name
Funding Source
Organization
Rhinology division ORL-HNS Department Cipto Mangunkusumo General Hospital
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
The ethics commitee of the faculty of medicine, University of Indonesia- Cipto Mangunkusumo Hospital
Address
University Indonesia Faculty of Medicine Building , jl salemba raya No 6 Jakarta 10430
Tel
62213912477
humas@fk.ui.ac.id
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
university of Indonesia
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 18 | 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
24
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 03 | 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 | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051620
