UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051620