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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042415
Receipt No. R000048414
Scientific Title Observational study of dryness of throat
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/11

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Basic information
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
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes The amount of saliva secretion
Key secondary outcomes Dry throat VAS

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 11 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 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
Other related information Confirm of the relationship between dryness of throat and saliva properties

Management information
Registered date
2020 Year 11 Month 11 Day
Last modified on
2020 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048414

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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