UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044256 |
|---|---|
| Receipt number | 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 14:29:39 |
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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
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
shiraishi094@eps.co.jp
Sponsor or person
Institute
non-profit organization Japan Health Promotion Support Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050340
