UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033438
Receipt number R000038126
Scientific Title Improvement effect on halitosis of Terminalia bellirica compounded food
Date of disclosure of the study information 2018/07/21
Last modified on 2020/03/25 09:26:24

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Basic information

Public title

Improvement effect on halitosis of Terminalia bellirica compounded food

Acronym

Improvement effect on halitosis of Terminalia bellirica compounded food

Scientific Title

Improvement effect on halitosis of Terminalia bellirica compounded food

Scientific Title:Acronym

Improvement effect on halitosis of Terminalia bellirica compounded food

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the effect of test food for men and women with bad breath

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Instrument measurement, evaluation of halitosis by Olfactory Measurement Operator

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Compare levels of halitosis before and after ingestion of test food

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1.Subjects suffering from strong bad breath
2.Subjects who were pointed out that their bad breath was severe from others

Key exclusion criteria

1.Subject not suffering from bad breath
2. Subjects who have never been pointed out that their bad breath is severe from others

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatomo Najima

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code


Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Email

info@yakujihou.org


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Kaneko

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code


Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Homepage URL


Email

info@yakujihou.org


Sponsor or person

Institute

Japan Clinical Trial Association

Institute

Department

Personal name



Funding Source

Organization

EC STUDIO 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


Address


Tel


Email



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

2018 Year 07 Month 21 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

2018 Year 06 Month 14 Day

Date of IRB

2018 Year 06 Month 14 Day

Anticipated trial start date

2018 Year 07 Month 21 Day

Last follow-up date

2018 Year 07 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 18 Day

Last modified on

2020 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038126


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name