UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041584
Receipt number R000047475
Scientific Title The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.
Date of disclosure of the study information 2020/08/28
Last modified on 2021/02/26 10:36:30

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Basic information

Public title

The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.

Acronym

The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.

Scientific Title

The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.

Scientific Title:Acronym

The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate test food on nasal and ocular symptoms associated with house dust and mites for 8 weeks using placebo as a control.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

QOL questionnaire, Diary of discomfort of eyes and nose.

Key secondary outcomes

Specific IgE (house dust and mites),
Eosinophils in nasal discharge,
Medical examination for check subjects nasal condition, and VAS-questionnaire.


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

Ingestion of the test product for 8 consecutive weeks.

Interventions/Control_2

Ingestion of the placebo for 8 consecutive 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 from 20 to 64 years of age.
(2)Subjects who have frequently presence of nasal and ocular discomfort.
(3)Subjects who have positive for specific IgE against house dust or mites.
(4)Subjects who are judged as healthy person by the investigator.
(5)Subjects who do not take anti- allergic drug a count for more than half of whole.

Key exclusion criteria

(1)Subjects who are constantly using drugs or health food affecting nasal and ocular discomfort.
(2)Subjects who frequently visit a otorhinology.
(3)Subjects who have severe nasal symptoms.
(4)Subjects who are complicated by bronchial asthma.
(5)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
(6)Subjects who are under medication which may influence the outcome of the study (e.g. specific desensitization therapy).
(7)Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function.
(8)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
(9)Subjects having possibilities for emerging allergy related to the study.
(10)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(11)Subjects who have participated in other clinical studies at the time of this study start.
(12)Subjects who intend to become pregnant or lactation plan during
a study period.
(13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(14)Subjects judged as unsuitable for the study by the investigator for other reasons.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Zentani

Organization

A・Pharma Kindai Co., Ltd.

Division name

Sales department

Zip code

577-0818

Address

3-5-14, Kowakae, Higashiosaka, Osaka

TEL

06-4307-5207

Email

zentani@a-pharma-kindai.co.jp


Public contact

Name of contact person

1st name Chiharu
Middle name
Last name Goto

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

c.goto@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

A・Pharma Kindai Co., Ltd.

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

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

t.saito@ttc-smo.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 08 Month 28 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

2020 Year 08 Month 06 Day

Date of IRB

2020 Year 08 Month 06 Day

Anticipated trial start date

2020 Year 08 Month 29 Day

Last follow-up date

2020 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

2020 Year 08 Month 28 Day

Last modified on

2021 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047475


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name