UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038255 |
|---|---|
| Receipt number | R000043610 |
| Scientific Title | Influence on reducing allergies reactions of eyes and nose by consumption of test foods |
| Date of disclosure of the study information | 2020/10/18 |
| Last modified on | 2020/10/19 09:33:39 |
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Basic information
Public title
Influence on reducing allergies reactions of eyes and nose by consumption of test foods
Acronym
Influence on reducing allergies reactions of eyes and nose by consumption of test foods
Scientific Title
Influence on reducing allergies reactions of eyes and nose by consumption of test foods
Scientific Title:Acronym
Influence on reducing allergies reactions of eyes and nose by consumption of test foods
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the influence on reducing allergies reactions of eyes and nose by 8 weeks consumption of test food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal symptom score of JRQLQ
Key secondary outcomes
* Nasal symptom score for severity classification of allergies
* Nasal examination
* Ocular symptoms score
* QOL score
* Concentration of serum non-specific IgE
* Concentration of serum specific IgE against CAP16
* White blood cell image
* Nasal discharge neutrophils
* Medication Score
* Incidence of adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake two packs of test food a day for eight weeks.
Interventions/Control_2
Intake two packs of control food a day for eight 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20 to 64 when informed consent, who match the inclusion criteria (2) and (4) or (3) and (4) as be shown below.
2) Healthy subjects who have, include used to have, nose allergy. And healthy subjects who don't and/or won't use allergy treatment medicines, before the test and/or during the test period.
3) Light symptom subjects who have, include used to have, nose allergy. And those subjects who will use allergy treatment medicines sometimes (not regularly), before the test and/or during the test period.
4) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria
1) Subjects who plan some treatment during test period.
2) Subjects who use oral steroid medicine in order to treatment allergy.
3) Subjects who regularly use and/or are not able to quit use medicines, quasi-drugs and herbal medicines those have the inhibition effects of allergy and concerned to give influence for test results.
4) Subjects who regularly use and/or are not able to quit use healthy foods those advocate to have the inhibition effects of allergy and concerned to give influence for test results.
5) Females who are pregnant or could become pregnant, and who are lactating.
6) Subjects who have previous and/or current medical history of serious disease
7) Subjects who use oral medicines and/or nasal drops those are antihistamine or anti-allergy
8) Subjects who don't intake test food and/or don't enter the Web diary against the instruction of administrator during test period.
9) Subjects who excessive alcohol intake.
10) Subjects who have non-allergic nasal inflammation
11) Subjects who can't eat lotus root
12) Subjects who have food allergy
13) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
14) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
15) Males who donated over 400mL blood within the last three months to the current study.
16) Females who donated over 400mL blood within the last four months to the current study.
17) Males who will be collected over 1200mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
18) Females who will be collected over 800mL blood when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
19) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Nagamine |
Organization
NICHIREI BIOSCIENCES INC.
Division name
Global Innovation Center
Zip code
350-1331
Address
1-11-8, Shin Sayama, Sayama-shi, Saitama, 350-1331, Japan
TEL
04-2930-2108
nagaminek@nichirei.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
NICHIREI BIOSCIENCES INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2020 | Year | 10 | Month | 18 | 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
| 2019 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043610
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