UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048069 |
|---|---|
| Receipt number | 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 20:50:50 |
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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
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
syonekura@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University School of Medicine
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
Chiba University School of Medicine
Address
1-8-1, Inohana, Chuo-ku
Tel
043-2262137
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054786
