UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038343
Receipt number R000043699
Scientific Title A study of effects of food containing herbal extract on throat discomfort
Date of disclosure of the study information 2020/11/30
Last modified on 2020/01/29 19:14:18

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Basic information

Public title

A study of effects of food containing herbal extract on throat discomfort

Acronym

A study of effects of food containing herbal extract on throat discomfort

Scientific Title

A study of effects of food containing herbal extract on throat discomfort

Scientific Title:Acronym

A study of effects of food containing herbal extract on throat discomfort

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of the test food on throat or oral quality of life.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Japanese version of the Glasgow Edinburgh Throat Scale (GETS-J)

Key secondary outcomes

GOHAI (Geriatric Oral Health Assessment Index)
Anti-aging quality of life (Oral interview)
Opportunistic infection test
Salivary s-IgA concentration
Salivary secretion rate
Salivary s-IgA secretion rate


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

Intake of 5 grains of test food per day for 5 consecutive days

Interventions/Control_2

Intake of 5 grains of placebo per day for 5 consecutive days

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) Males and females with discomfort in the throat
(3) Subjects who can carry out opportunistic infection inspection
(4) Subjects who can visit designated medical institution on visit scheduled date
(5) Subjects who fully understands the purpose and content of this research and obtains written consent

Key exclusion criteria

(1) Subjects who take candy, or foods which richly contain the components of test food regularly
(2) Subjects who take health foods or supplements related to immune enhancement
(3) Subjects who had drag or treatment which affect result within 1 month
(4) Subjects who had treatment for tooth or mouth within 1 month
(5) Subjects who have troubles in the mouth
(6) Subjects who bleed more than once a week and cannot be prevented
(7) Subjects who work night and day shift or who work manual labor
(8) Subjects who regularly practice intense exercise such as marathons
(9) Subjects who cannot perform the procedures of various tests conducted during the research period as prescribed
(10) Subjects who have nervous system diseases or severe diseases such as, such as diabetes, liver disease, kidney disease, heart disease, and diseases that affect the secretion of corticosteroids
(11) Subjects having possibilities for emerging allergy related to the study
(12) Subjects who are judged as unsuitable for laboratory value or physical examination value
(13) Subjects who are, or are planning to be pregnant or breastfeeding during study
(14) Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study
(15) Subjects who are judged as unsuitable due to lifestyle questionnaire
(16) Subjects who are judged as unsuitable by doctor for other reasons

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Naruhiko
Middle name
Last name Hongo

Organization

Kanro Inc.

Division name

Research and Development Dept

Zip code

135-0051

Address

2-20-12, Edagawa, Koto Ku, Tokyo

TEL

03-5634-6000

Email

Naruhiko_hongou@kanro.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Nakagawa

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

0354595329

Homepage URL


Email

t.nakagawa@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Kanro Inc.

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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

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 11 Month 30 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

20

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 09 Month 12 Day

Date of IRB

2019 Year 09 Month 12 Day

Anticipated trial start date

2019 Year 10 Month 21 Day

Last follow-up date

2019 Year 12 Month 25 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 10 Month 20 Day

Last modified on

2020 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name