UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052952 |
|---|---|
| Receipt number | R000060418 |
| Scientific Title | A Confirmatory Study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/11/30 09:44:12 |
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Basic information
Public title
A Confirmatory Study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
A Confirmatory Study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of test food
Scientific Title
A Confirmatory Study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A Confirmatory Study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of test food
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on uncomfortable feelings in eyes and nose in healthy Japanese subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ)
Key secondary outcomes
1. Grading the severity of allergic rhinitis
2. Medical examination for check subjects nasal and eye symptom survey and nasal condition
3. The number of eosinophils in nasal discharge and specific IgE (Four types: Japanese red-cedar, cypress, Dermatophagoides pteronyssinus, and house dust)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Plant A oil
Administration: Take two packets (4.4 g/packet x two packets, in total 8.8 g) at any time during the day
Interventions/Control_2
Duration: 12 weeks
Test food: Plant B oil
Administration: Take two packets (4.4 g/packet x two packets, in total 8.8 g) at any time during the day.
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
1. Japanese
2. Healthy adult males and females from 20 to 65 years of age
3. Subjects who have eyes and nose discomfort by pollen at last two years
4. Subjects who have positive for specific IgE against cedar or cypress or house dust or mites.
5. Subjects who do not use antiallergic drugs at the agreement to participate in this trial
6. Subjects whose total score of JRQLQ is bad at screening
7. Subjects who receive a comprehensive explanation of this study, can understand it, and provide a written informed consent
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who are allergic to medicines and/or the test food related products (particularly, plant A, plant A oil, plant B, or plant B oil)
3. Subjects who are currently, exercise therapy and diet therapy are performed/ planning to under the supervision of a physician
4. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
5. Subjects who are receiving long-term drug treatment (antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the trial
6. Subjects who are currently taking medicines, foods for specified health uses, health foods, etc. (e.g. vitamins, lactic acid drinks/supplements for the purpose of alleviating discomfort in the eyes and/or nose.)
7. Subjects who have a nasal irrigation habit
8. Subjects who do not go out more than once a week
9. Subjects whose eating habit is extremely irregular
10. Subjects who are routinely drinking a large amount of alcohol.
11. Subjects whose life rhythms are irregular due to shift work, night work, or others
12. Subjects who have been enrolled in other clinical trials within one month before the agreement to participate in this trial or plan to participate another trial during this trial
13. Subjects who are judged as ineligible to participate in this study by the physician
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fukumitsu |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
046-222-6963
sfukumitsu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Tomaru |
Organization
Synapse planning Co.,Ltd.
Division name
Representative of Director
Zip code
162-0054
Address
3F T-Bldg., 7-5, Kawada-chou, Shinjyuku-ku, Tokyo, Japan.
TEL
03-5604-9442
Homepage URL
volunteer@synaps.co.jp
Sponsor or person
Institute
Synapse planning Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
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 Tsukiji Futaba Clinic
Address
Hosokawa Tsukiji Bild. 6th Floor, Tsukiji 1-9-9, Cyuou-ku Tokyo
Tel
03-6226-5812
tohru@hikobae.net
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
医療法人社団曙光会コンフォガ－デンクリニック（東京）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | 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
| 2023 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060418
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| Registered date | File name |
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