UMIN-CTR Clinical Trial

Public title

Observational study of dryness of throat

Acronym

Observational study of dryness of throat

Scientific Title

Observational study of dryness of throat

Scientific Title:Acronym

Observational study of dryness of throat

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Confirm of the relationship between dryness of throat and saliva properties

Basic objectives2

Others

Basic objectives -Others

Confirm of the relationship between dryness of throat and saliva properties

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The amount of saliva secretion

Key secondary outcomes

Dry throat VAS

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

-Healthy Male and females
-subjects giving written informed consent.

Key exclusion criteria

1.Those with regularly use cholinergic drugs, anticholinergic drugs (possible dry mouth as one of the side effects) and Kampo that affects dry mouth
2.Subjects who cannot stop ingesting foods that are expected to alleviate dry mouth (throat lozenges and tablet products that have been shown to improve dry mouth) during the test period.
3.Subjects with regularly use first-generation antihistamines (possible dry mouth as one of the side effects)
4.Subjects who cannot stop the actions that significantly affect the dryness of the mouth (stretching the throat and neck, salivary gland massage) from 5 minutes before the evaluation to the end.
5.Subjects who have or are suspected of having a history of Sjogren's syndrome * Sjogren's syndrome is a type of autoimmune disease in which salivary gland secretion is impaired.
6.Subjects with suffer from diseases related to salivary glands such as xerostomia
7.Subjects with undergoing radiation therapy near the oral cavity
8.Subjects with pregnant, those who are willing to become pregnant during the test period, those who are breastfeeding
9.Subjects with suffering from diseases (liver disease, renal disease, diabetes, heart disease, respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergic disease, mental disease, cancer , Infectious diseases, etc.), Those who need continuous hospital visits and follow-up
10.Subjects with judged by the person in charge of testing and research to be unsuitable as participants

Target sample size

20

Name of lead principal investigator

1st name	Hidefumi
Middle name
Last name	Kitazawa

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

TEL

+81-3-5630-7268

Email

kitazawa.hidefumi@kao.com

Name of contact person

1st name	Mai
Middle name
Last name	Umeda

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

TEL

+81-3-5630-7268

Homepage URL

Email

umeda.mai@kao.com

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社（栃木県）

Date of disclosure of the study information

2020

Year

11

Month

11

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

Preinitiation

Date of protocol fixation

2020

Year

10

Month

26

Day

Date of IRB

2020

Year

10

Month

26

Day

Anticipated trial start date

2020

Year

11

Month

11

Day

Last follow-up date

2020

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Confirm of the relationship between dryness of throat and saliva properties

Registered date

2020

Year

11

Month

11

Day

Last modified on

2020

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048414