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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000045185
Receipt No. 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

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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
Email 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
Email indraparmaditya@gmail.com

Sponsor
Institute there were no sponsors available
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051620

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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