UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039243
Receipt number R000044685
Scientific Title Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.
Date of disclosure of the study information 2020/01/23
Last modified on 2021/10/28 12:16:02

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Basic information

Public title

Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.

Acronym

Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.

Scientific Title

Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.

Scientific Title:Acronym

Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine effects of a test food containing an extract of unripe mandarins for reducing allergic reaction of eyes or nose.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Indexes for allergic rhinitis (Japan Rhinitis Quality of Life Questionnaire No. 1(1), grading the severity of allergic rhinitis(2), grading of local findings(2), eyes and nose condition based on subject's diary(3), effect measurement(4))
(1):Week 0, 2, 4, 6, 8, 10, 12.
(2):Week 0, 6, 12.
(3)From the first day of ingestion of a test material to the last day of the test.
(4)Week 12.

Key secondary outcomes

*Secondary outcomes
[1]Specific measurementf of nasal discharge and blood (nasal discharge eosinophils(1), eosinophil(1), nonspecific IgE(1), specific IgE(2)).
(1):Week 0, 6, 12.
(2):Week 0, 12.

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

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


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

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test food (2 capsules once a day for 12 weeks).

Interventions/Control_2

Oral ingestion of the placebo food (2 capsules 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



Eligibility

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 20-64 years.
[2]Individuals who are healthy and are not suffered from a chronic malady.
[3]Individuals with allergic reaction of eyes and nose in early spring.
[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 using medical products.
[2][2]Individuals who use an antiallergic drug or steroid drug or will use during the test period.
[3]Individuals who have history of intranasal laser therapy to reduce allergic symptoms.
[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 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 whose BMI is over 30 kg/m2.
[11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing similar composition with a test food in the past 1 month or will ingest those foods during the test period.
[13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period to reduce allergic symptoms.
[14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60 mg/day).
[15]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[16]Individuals who are or are possibly, or are lactating.
[17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[18]Individuals who are or whose family is engaged in healthy or functional foods.
[19]Individuals judged inappropriate for the study by the principal.

Target sample size

68


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Ono

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc


Public contact

Name of contact person

1st name Ryoma
Middle name
Last name Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Nikken Foods 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

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.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



Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 23 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

2019 Year 12 Month 10 Day

Date of IRB

2019 Year 12 Month 11 Day

Anticipated trial start date

2020 Year 01 Month 28 Day

Last follow-up date

2020 Year 04 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Revision of the Protocol (2nd version; 16th April 2020)
Due to the declaration of the State of Emergency by the Japanese Government and the requirement of staying at home by both Japanese and Tokyo Metropolitan Governments in relation to the COVID-19, the safety and security of the subjects and staff have been our first priority. As a result, we decided to cancel the test at the Week 12 and to extend it to the Week 16.

Ueno-Asagao Clinic Ethical Review Committee (Approval date: 17th April 2020, Approval number: 2019-39-J1)

Revision of the Protocol (3rd version; 15th May 2020)
Due to the extend period of the declaration of the State of Emergency by the Japanese Government and the requirement of staying at home by both Japanese and Tokyo Metropolitan Governments in relation to the COVID-19, we decided to cancel the test at the Week 16 and to extend it to the Week 18.

Ueno-Asagao Clinic Ethical Review Committee (Approval date: 15th March 2020, Approval number: 2019-39-J2)


Management information

Registered date

2020 Year 01 Month 23 Day

Last modified on

2021 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044685


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name