UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038534
Receipt number R000043917
Scientific Title Comprehensive search for lipid mediators in nasal discharge of patients with allergic rhinitis
Date of disclosure of the study information 2019/11/11
Last modified on 2023/05/15 10:17:28

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Basic information

Public title

Comprehensive search for lipid mediators in nasal discharge of patients with allergic rhinitis

Acronym

Comprehensive search for lipid mediators in nasal discharge of patients with allergic rhinitis

Scientific Title

Comprehensive search for lipid mediators in nasal discharge of patients with allergic rhinitis

Scientific Title:Acronym

Comprehensive search for lipid mediators in nasal discharge of patients with allergic rhinitis

Region

Japan


Condition

Condition

Allergic rhinitis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comprehensive search for lipid mediator concentrations in nasal discharge of allergic rhinitis cases

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Lipid mediator concentrations in nasal discharge

Key secondary outcomes

The relationship between lipid mediator concentration and nasal symptoms


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

Mite induced allergic rhinitis cases or cold cases

Key exclusion criteria

Patients treated with anti-allergic drugs

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Syuji
Middle name
Last name Yonekura

Organization

Chiba University Hospital

Division name

Otolaryngology

Zip code

260-0856

Address

1-8-1 Inohana,Chuo-ku Chiba

TEL

043-222-7171

Email

syonekura@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Syuji
Middle name
Last name Yonekura

Organization

Chiba University Hospital

Division name

Otolaryngology

Zip code

260-0856

Address

1-8-1 Inohana,Chuo-ku Chiba

TEL

043-222-7171

Homepage URL


Email

syonekura@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Otorhinolaryngology in Chiba University hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital

Address

1-8-1 Inohana,Chuo-ku Chiba

Tel

043-222-7171

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

2019 Year 11 Month 11 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

2019 Year 07 Month 16 Day

Date of IRB

2019 Year 09 Month 27 Day

Anticipated trial start date

2019 Year 11 Month 11 Day

Last follow-up date

2024 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Comprehensive search for lipid mediator concentrations in nasal discharge of allergic rhinitis cases


Management information

Registered date

2019 Year 11 Month 11 Day

Last modified on

2023 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043917


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name