UMIN-CTR Clinical Trial

Public title

Effects of a Test Food for Reducing Discomfort of Eyes or Nose

Acronym

Effects of a Test Food for Reducing Discomfort of Eyes or Nose

Scientific Title

Effects of a Test Food for Reducing Discomfort of Eyes or Nose

Scientific Title:Acronym

Effects of a Test Food for Reducing Discomfort of Eyes or Nose

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate effect of a test food for reducing discomfort of eyes and nose and its safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Indexes for allergic rhinitis (grading the severity of allergic rhinitis [Week 0, 4, 8, 12]; grading of local findings [Week 0, 4, 8, 12]; effect measurement [Week 12]; Japan Rhinitis Quality of Life Questionnaire No. 1 [Week 0, 2, 4, 6, 8, 10, 12])

Key secondary outcomes

*Secondary outcomes
[1]Nasal discharge eosinophils (Week 0, 12)
[2]Blood IgE (Week 0, 12)
[3]Japanese edition of Profile of Mood States (2nd edition) (Week 0, 4, 8, 12)

*Safety evaluation
[1]Hematologic test (Week 0, 4, 8, 12)
[2]Blood biochemical test (Week 0, 4, 8, 12)
[3]Urine analysis (Week 0, 4, 8, 12)
[4]Blood pressure, pulsation (Week 0, 4, 8, 12)
[5]Weight, body fat percentage, BMI (Week 0, 4, 8, 12)
[6]Doctor's questions (Week 0, 4, 8, 12)

*Other indexes
[1]Questionnaire for allergic rhinitis (Week 0)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test food (6 tablets once a day for 12 weeks)

Interventions/Control_2

Oral ingestion of the placebo food (6 tablets once a day for 12 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 20-65 years.
[2]Individuals who are healthy and are not suffered from a chronic malady.
[3]Individuals with allergic rhinitis-symptoms.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals whose grade for the severity of allergic rhinitis is "severe" or "most severe".
[2]Individuals who visit a hospital or use a drug to treat perennial allergic rhinitis or pollinosis (except using nose drops and eye drops of category-3 OTC).
[3]Individuals using medical products.
[4]Individuals who are a patient of or have a history of bronchial disease.
[5]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[6]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[7]Individuals who are sensitive to a test food, other foods, and medical products.
[8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease.
[9]Individuals who are a patient or have a history of or endocrine disease.
[10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[11]Individuals who had an experience of side effects on blood sampling such as bad feeling or poor physical condition.
[12]Individuals who ingest food for specified health uses or foods with Function Claims (except individuals who can stop ingesting these food before an informed consent).
[13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[14]Individuals whose life style will change during the test period.
[15]Individuals who are or are possibly, or are lactating.
[16]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[17]Individuals who are or whose family is engaged in healthy or functional foods.
[18]Individuals judged inappropriate for the study by the principal.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuhiro Sugimoto

Organization

Otsubokai Medical Corporation Tohto Bunkyo Hospital

Division name

Head

Zip code

Address

3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN

TEL

03-3831-2181

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

HIGASHIMARU SHOYU CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

09

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

21

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

09

Month

11

Day

Last modified on

2017

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033198