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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048069
Receipt No. R000054786
Scientific Title Exploratory research on the elucidation of the therapeutic effect manifestation mechanism of allergic rhinitis
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/15

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Basic information
Public title Exploratory research on the elucidation of the therapeutic effect manifestation mechanism of allergic rhinitis
Acronym Study on the therapeutic effect of allergic rhinitis
Scientific Title Exploratory research on the elucidation of the therapeutic effect manifestation mechanism of allergic rhinitis
Scientific Title:Acronym Study on the therapeutic effect of allergic rhinitis
Region
Japan

Condition
Condition Allergic rhinitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An exploratory study will be conducted on the relationship between changes in clinical symptoms due to treatment and changes in biomarkers measured using blood samples.
Basic objectives2 Others
Basic objectives -Others Search for biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in biomarkers measured using blood samples
Key secondary outcomes Changes in clinical symptoms due to treatmen

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
5 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria A case of 5 years or older who was diagnosed with allergic rhinitis in an allergy outpatient department of the Department of Otorhinolaryngology, Chiba University Hospital
Key exclusion criteria Cases without treatment for allergic rhinitis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Syuji
Middle name
Last name Yonekura
Organization Chiba university
Division name Otolaryngology
Zip code 260-0856
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi
TEL 043-226-2137
Email syonekura@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Syuji
Middle name
Last name Yonekura
Organization Chiba university
Division name Otolaryngology
Zip code 206-0856
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi
TEL 043-226-2137
Homepage URL
Email syonekura@faculty.chiba-u.jp

Sponsor
Institute Chiba University School of Medicine
Institute
Department

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 Chiba University School of Medicine
Address 1-8-1, Inohana, Chuo-ku
Tel 043-2262137
Email syonekura@faculty.chiba-u.jp

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

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 20 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 11 Month 15 Day
Date of IRB
2021 Year 11 Month 30 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we will explore the relationship between changes in clinical symptoms and changes in biomarkers measured using blood samples.

Management information
Registered date
2022 Year 06 Month 15 Day
Last modified on
2022 Year 06 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054786

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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