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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016980
Receipt No. R000018292
Scientific Title Effects of nattokinase on the patients with eosinophilic chronic rhinosinusitis
Date of disclosure of the study information 2015/04/01
Last modified on 2015/03/31

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Basic information
Public title Effects of nattokinase on the patients with eosinophilic chronic rhinosinusitis
Acronym Effects of nattokinase on the patients with eosinophilic chronic rhinosinusitis
Scientific Title Effects of nattokinase on the patients with eosinophilic chronic rhinosinusitis
Scientific Title:Acronym Effects of nattokinase on the patients with eosinophilic chronic rhinosinusitis
Region
Japan

Condition
Condition Eosinophilic chronic rhinosinusitis
Classification by specialty
Pneumology Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Examination of the curative effect with the nattokinase in the eosinophilc chronic rhinosinusitis patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Evaluation improvement effect of the nasal polypus 8 weeks after the nattokinase dosage
Key secondary outcomes Evaluation symptom score, QOL, and CT score 8 weeks after the nattokinase dosage

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 160 patients with chronic rhinosinusitis take actual drug for 8 weeks.
Interventions/Control_2 160 patients with chronic rhinosinusitis take placebo for 8 weeks.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who had a diagnosis of eosinophilic chronic rhinosinusitis using JESREC (Japanese epidemiological survey of refractory eosinophilic chronic rhinosinusitis) diagnostic criteria.
Key exclusion criteria 1)The patient who is complicated with a nose disease (severe septum deviation, severe allergic rhinitis, nose or paranasal sinus tumor) that make this study difficult.

2)The case that the steroid dosage cannot cancel for the treatment of this disease and other diseases.

3)The case that has allergy for Natto or soybean.

4)Under during the pregnancy or the nursing

5)Patient during medical treatment of immunity

6)The patient who judged that the medical attendant was inappropriate
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeharu Fujieda
Organization University of Fukui
Division name Otorhinolaryngology Head & Neck Surgery
Zip code
Address 23-3, Matsuokashimoaizuki, eiheiji-cho, Yoshida-gun, Fukui 910-1193 JAPAN
TEL 0776-61-3111
Email sfujieda@g.u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeharu Fujieda
Organization University of Fukui
Division name Otorhinolaryngology Head & N
Zip code
Address 23-3, Matsuokashimoaizuki, eiheiji-cho, Yoshida-gun, Fukui 910-1193 JAPAN
TEL 0776-61-3111
Homepage URL
Email sfujieda@g.u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 福井大学(福井県)、獨協大学(埼玉県)、広島大学(広島県)、兵庫医科大学(兵庫県)、
自治医科大学附属さいたま医療センター(埼玉県)、東京慈恵会医科大学(東京都)、順天堂大学医学部附属順天堂医院(東京都)、関西医科大学(大阪府)、金沢医科大学(石川県)、
三重大学(三重県)、日本医科大学武蔵小杉病院(神奈川県)、岡山大学(岡山県)、
札幌医科大学(北海道)、東邦大学(東京都)、東京大学(東京大学)、横浜市立大学附属市民総合医療センター(神奈川県)、日赤和歌山医療センター(和歌山県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 31 Day
Last modified on
2015 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018292

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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