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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044256
Receipt No. R000050340
Scientific Title A study on immunoglobulin behavior in desensitization therapy
Date of disclosure of the study information 2021/05/19
Last modified on 2021/05/19

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Basic information
Public title A study on immunoglobulin behavior in desensitization therapy
Acronym A study on immunoglobulin behavior in desensitization therapy
Scientific Title A study on immunoglobulin behavior in desensitization therapy
Scientific Title:Acronym A study on immunoglobulin behavior in desensitization therapy
Region
Japan

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

Objectives
Narrative objectives1 Investigate immunoglobulins
Basic objectives2 Others
Basic objectives -Others Elucidation of the mechanism of immunity
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Immunoglobulin levels
Key secondary outcomes

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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Patients who have rhinitis symptoms for 2 years or more due to cedar pollen allergy
Key exclusion criteria Patients taking steroids
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Tadao
Middle name
Last name Enomoto
Organization non-profit organization Japan Health Promotion Support Organization
Division name none
Zip code 640-8269
Address 68, Komatsubaratoori 3-chome, Wakayama city, Wakayama, Japan
TEL 073-432-0582
Email t-enomoto@tempo.ocn.ne.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Shiraishi
Organization EPS Holdings, Inc.
Division name Souken Center
Zip code 162-0821
Address 9F Kagurazaka AK Building, 1-8 Tsukudo-cho, Shinjuku-ku, Tokyo, Japan
TEL 070-3023-8212
Homepage URL
Email shiraishi094@eps.co.jp

Sponsor
Institute non-profit organization Japan Health Promotion Support Organization
Institute
Department

Funding Source
Organization EPS holdings Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Station Clinic Research Ethics Committee
Address 3-12-8, Takaban, Meguro-ku, Tokyo
Tel 03-6452-2712
Email saito876@eps.co.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 だけクリニック耳鼻咽喉科・アレルギー科(和歌山県)、池田耳鼻いんこう科院(和歌山県)

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 19 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Immunoglobulin is measured in patients with rhinitis due to Sugi pollen allergy.

Management information
Registered date
2021 Year 05 Month 19 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050340

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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