UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027493
Receipt number R000031502
Scientific Title study on salivation effect of encapsulated food product containing sichuan pepper oil.
Date of disclosure of the study information 2017/05/26
Last modified on 2017/05/25 18:36:29

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Basic information

Public title

study on salivation effect of encapsulated food product containing sichuan pepper oil.

Acronym

clinical evaluation of saliva secrection
effect pepper oil.

Scientific Title

study on salivation effect of encapsulated food product containing sichuan pepper oil.

Scientific Title:Acronym

clinical evaluation of saliva secrection
effect pepper oil.

Region

Japan


Condition

Condition

Xerostomia

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1.amount of saliva secretion
2.number of candida colonies in the oral
3.evaluation of subjectve symptoms
4weeks

Basic objectives2

Others

Basic objectives -Others

Explore safty

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Amount of saliva secretion

Key secondary outcomes

1.Number of Candida colonies in the oral
2.Evaluation of subjective symptoms


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

1.intake
capsules/day/before meal/for 4weeks
2.saxon test
3.candida colony test
4.Interview/subjective symptoms

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

80 years-old >

Gender

Female

Key inclusion criteria

1.a person diagnosed as being a dry mouth at the time of initial visit by saliva at rest and saliva at stimulation and who has subjective symptoms of mouth dryness
2.Outpatient
3.Non-smoker
4.Others who were judged to be suitable for participation by the both investigator
and doctor in charge.
5.Subjects who agree to participate in this study with a written in tormwd consent.

Key exclusion criteria

smoker

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Ichiro SAITO,D.D.S.,Ph.D.

Organization

Tsurumi University

Division name

Department of Pathology, School of Dental Medicine

Zip code


Address

2-1-3,Tsurumi,Tsurumi-ku,Yokohama,Kanagawa,230-0063,Japan

TEL

045-580-8361

Email

Saito-i@tsurumi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Assistant Protessor Koufuchi RYO,D.D.S.,Ph.D.

Organization

Tsurumi University

Division name

Department of Pathology, School of Dental Medicine

Zip code


Address

2-1-3,Tsurumi,Tsurumi-ku,Yokohama,Kanagawa,230-0063,Japan

TEL

045-580-8362

Homepage URL


Email

ryo-k@tsutumi-u.ac.jp


Sponsor or person

Institute

Tsurumi University
Department of Pathology,school of Dental Medicine

Institute

Department

Personal name



Funding Source

Organization

Aliment Industry Co.,LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

japan


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

鶴見大学歯学部病院


Other administrative information

Date of disclosure of the study information

2017 Year 05 Month 26 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

2017 Year 05 Month 26 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 25 Day

Last modified on

2017 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031502


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name