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
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
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
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
