UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038861 |
|---|---|
| Receipt number | R000044309 |
| Scientific Title | A study to examine the effects of food intake on relief from eye and nasal discomfort. |
| Date of disclosure of the study information | 2019/12/26 |
| Last modified on | 2020/08/05 15:25:47 |
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Basic information
Public title
A study to examine the effects of food intake on relief from eye and nasal discomfort.
Acronym
A study to examine the effects of food intake on relief from eye and nasal discomfort.
Scientific Title
A study to examine the effects of food intake on relief from eye and nasal discomfort.
Scientific Title:Acronym
A study to examine the effects of food intake on relief from eye and nasal discomfort.
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study to examine the effects of improving eye and nasal discomfort by ingesting food derived from Shiikuwasa (Citrus depressa Hayata).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese Rhinoconjunctivitis Quality of Life Questionnaire version 2002 (JRQLQ No1)
Key secondary outcomes
Assessment of the nasal cavity
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
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The foods that are contained nobiletin and tangeretin
Interventions/Control_2
Placebo
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20 to 49
2. Persons who have perennial allergies or seasonal allergies as subjective symptoms
3. Persons who can obtain consent for voluntary study participation in writing
4. Persons who are not ill
Key exclusion criteria
1. Persons who regularly consume yogurt or lactic acid bacteria food (more than 4 times a week)
2. Persons who regularly consume citrus fruits and processed foods (at least 4 times a week)
3. Participants in foods and health foods that are described as containing nobiletin and tangeretin
4. Persons who must continue to use drugs that may affect nose and eye symptoms (antiallergic drugs, antihistamines, steroidal vasoconstrictors, antihypertensive drugs, etc.)
6. Persons who may develop allergies to the test foods.
7. Persons who are judged to be inappropriate as subjects from the results of the lifestyle questionnaire
8. Participants in other clinical studies at the start of this study
9. Persons who are pregnant or breastfeeding during the study period
10. A person who is judged unsuitable for study participation by the investigator
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | YUTAKA |
| Middle name | |
| Last name | OGIDOH |
Organization
Okinawa TLO Co., Ltd.
Division name
Not Division
Zip code
903-0213
Address
University of the Ryukyus - Industry-academia-government collaboration building 3F
TEL
098-895-1701
ogidoh@okinawa-tlo.com
Public contact
Name of contact person
| 1st name | YUTAKA |
| Middle name | |
| Last name | OGIDOH |
Organization
Okinawa TLO Co., Ltd.
Division name
Not Division
Zip code
903-0213
Address
University of the Ryukyus - Industry-academia-government collaboration building 3F
TEL
098-895-1701
Homepage URL
ogidoh@okinawa-tlo.com
Sponsor or person
Institute
Okinawa TLO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Okinawa TLO Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Samon-Cho 13, Isobe Build. 2F, Shinjyuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.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
いきいきクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 26 | 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
34
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 | 10 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 10 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044309
