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

* 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

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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name