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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012877
Receipt No. R000014972
Scientific Title Efficacy of preseasonal treatment on the quality of life in seasonal allergic rhinitis
Date of disclosure of the study information 2014/01/17
Last modified on 2014/08/18

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Basic information
Public title Efficacy of preseasonal treatment on the quality of life in seasonal allergic rhinitis
Acronym Efficacy of preseasonal treatment on QOL in seasonal allergic rhinitis
Scientific Title Efficacy of preseasonal treatment on the quality of life in seasonal allergic rhinitis
Scientific Title:Acronym Efficacy of preseasonal treatment on QOL in seasonal allergic rhinitis
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of preseasonal treatment on QOL in subjects with Japanese cedar pollinosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese cedar pollinosis
Key exclusion criteria Female patients are excluded if they are pregnant or breast-feeding. Patients with nasal polyps or obvious nasal structural abnormalities such as nasal septum deviation, or with acute sinusitis or other upper respiratory infections, are also excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuyo Miyanohara
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Dept. of Otolaryngology-Head and Neck Surgery
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima, 890-8520, Japan
TEL 099-275-5410
Email iusu33@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuyo Miyanohara
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Dept. of Otolaryngology-Head and Neck Surgery
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima, 890-8520, Japan
TEL 099-275-5410
Homepage URL
Email entjm@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Dept. of Otolaryngology-Head and Neck Surgery
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Dept. of Otolaryngology-Head and Neck Surgery
Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 01 Month 17 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
2014 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is planned to evaluate the efficacy and safety of preseasonal treatment in subjects with JC pollinosis, based on evaluation of quality of life (QOL).QOL was surveyed using the Japanese Allergic Rhinitis QOL Standard Questionnaire (JRQLQ) No.1 during the pollen season on the website.

Management information
Registered date
2014 Year 01 Month 16 Day
Last modified on
2014 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014972

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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