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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022976
Receipt No. R000026485
Scientific Title A study on the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth
Date of disclosure of the study information 2016/07/22
Last modified on 2019/06/14

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Basic information
Public title A study on the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth
Acronym Impact of the pineapple-extracted ceramide for dry mouth
Scientific Title A study on the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth
Scientific Title:Acronym Impact of the pineapple-extracted ceramide for dry mouth
Region
Japan

Condition
Condition xerostomia
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Subjective evaluation of dry mouth at before administration and two weeks after administration
Key secondary outcomes Moisture level, saliva wetness and number and form of fungiform papilla at before administration and two weeks after administration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 8 weeks
Taking one supplement tablet containing ceramide after breakfast one time per day after breakfast for 2 weeks. After four-week washout period, taking one placebo tablet after breakfast one time per day after breakfast for 2 weeks.
Interventions/Control_2 Duration: 8 weeks
Taking one placebo tablet after breakfast one time per day after breakfast for 2 weeks. After four-week washout period, taking one supplement tablet containing ceramide after breakfast one time per day after breakfast for 2 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria The person who have a feeling of dry mouth
Key exclusion criteria Subjects who have received radiotherapy or chemotherapy.
Subjects who have scheduled the extraction of teeth or the other oral surgical management.
Subjects who have a history of allergic reaction with pineapple and fruit.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Mamoru
Middle name
Last name Murakami
Organization Kagoshima University Medical and Dental Hospital
Division name Denture Prosthodontics Restoration
Zip code 890-8544
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 0992756222
Email kaku@dent.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Mamoru
Middle name
Last name Murakami
Organization Kagoshima University Medical and Dental Hospital
Division name Denture Prosthodontics Restoration
Zip code 890-8544
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 0992756222
Homepage URL
Email kaku@dent.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Maruzen pharmaceuticals 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 Kagoshima University Medical and Dental Hospital
Address 8-35-1 Sakuragaoka, Kagoshima
Tel 099-275-6222
Email kaku@dent.kagoshima-u.ac.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 鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 22 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
2016 Year 03 Month 28 Day
Date of IRB
2016 Year 03 Month 26 Day
Anticipated trial start date
2016 Year 07 Month 22 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026485

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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