UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022976 |
|---|---|
| Receipt number | 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 | 2019/07/19 13:48:29 |
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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
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
kaku@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Medical and Dental Hospital
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026485
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026485
Number of participants that the trial has enrolled
16
Results
The oral moisture significantly increased and the VAS score of "How is dryness of your mouth?" significantly improved after GCP tablets intake and not after placebo tablets intake. The number of fungiform papillae was not significantly different following GCP tablets or placebo tablets intake.
Results date posted
| 2019 | Year | 07 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were individuals who had xerostomia symptoms selected among the patients undergoing follow up visits at the Kagoshima University hospital between July 7, 2016 and January 31, 2019. Exclusion criteria were: (a) history of radiation therapy or chemotherapy; (b) history of food allergy, including pineapple; (c) schedule of oral surgical operations, including extraction of teeth, during the research period; and (d) age below 20 year.
Participant flow
In this study, participants and researchers were double blinded. Participants were randomly allocated into two groups; namely, Sequence 1, a group that took GCP tablets first and placebo tablets then (GCP-placebo); and Sequence 2, a group that took tablets in the reverse order (placebo-GCP).
Adverse events
none
Outcome measures
The oral moisture level, xerostomia symptoms, and number of fungiform papillae were evaluated before (G1 and P1) and after (G2 and P2) taking the GCP and placebo test sample for two weeks, respectively.
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 | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026485
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