UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038255
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043610

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.