UMIN-CTR Clinical Trial

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 2019/07/19 (Ver. 5)

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