UMIN-CTR Clinical Trial

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
Institute	TTC Co., Ltd
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043699