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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030809
Receipt No. R000035174
Scientific Title Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.
Date of disclosure of the study information 2018/02/19
Last modified on 2019/04/11

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Basic information
Public title Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.
Acronym Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.
Scientific Title Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis.
Scientific Title:Acronym Effects of narrow-band ultraviolet-B irradiation on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa 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 In the present study, an attempt is made to examine the effects of intranasal irradiation with narrow-band ultraviolet-B on gene expression of histamine H1 receptor and allergy-related cytokines in nasal mucosa of patients with allergic rhinitis. After intranasal irradiation with narrow-band ultraviolet-B was given once or once a day for 3 days, changes in levels of histamine H1 receptor and allergy-related cytokine mRNAs in the nasal mucosa are examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gene expression of histamine H1 receptor and allergy-related cytokines (IL-4, 5 and 9) in the nasal mucosa
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intranasal irradiation of narrow-band ultraviolet-B once or once a day for 3 days
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 Adult patients with allergic rhinitis
Key exclusion criteria Patients who was excluded by investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Takeda
Organization University of Tokushima School of Medicine
Division name Department of Otolaryngology
Zip code
Address 3-18-15 Kuramoto, Tokushima, Japan
TEL 088-633-7169
Email takeda@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Takeda
Organization University of Tokushima School of Medicine
Division name Department of Otolaryngology
Zip code
Address 3-18-15 Kuramoto, Tokushima, Japan
TEL 088-633-7169
Homepage URL
Email takeda@tokushima-u.ac.jp

Sponsor
Institute University of Tokushima
Institute
Department

Funding Source
Organization Japan Agency of Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 02 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 Completed
Date of protocol fixation
2018 Year 01 Month 04 Day
Date of IRB
2018 Year 02 Month 19 Day
Anticipated trial start date
2018 Year 02 Month 26 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 15 Day
Last modified on
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035174

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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