UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016980 |
|---|---|
| Receipt number | 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 08:26:38 |
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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
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
sfujieda@g.u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018292
