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 |
A study on the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth
Impact of the pineapple-extracted ceramide for dry mouth
A study on the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth
Impact of the pineapple-extracted ceramide for dry mouth
Japan |
xerostomia
Oral surgery | Dental medicine |
Others
NO
The purpose of this study is to evaluate the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth.
Efficacy
Exploratory
Explanatory
Phase I
Subjective evaluation of dry mouth at before administration and two weeks after administration
Moisture level, saliva wetness and number and form of fungiform papilla at before administration and two weeks after administration
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
Numbered container method
2
Treatment
Food |
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.
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
20 | years-old | <= |
Not applicable |
Male and Female
The person who have a feeling of dry mouth
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.
50
1st name | Mamoru |
Middle name | |
Last name | Murakami |
Kagoshima University Medical and Dental Hospital
Denture Prosthodontics Restoration
890-8544
8-35-1 Sakuragaoka, Kagoshima
0992756222
kaku@dent.kagoshima-u.ac.jp
1st name | Mamoru |
Middle name | |
Last name | Murakami |
Kagoshima University Medical and Dental Hospital
Denture Prosthodontics Restoration
890-8544
8-35-1 Sakuragaoka, Kagoshima
0992756222
kaku@dent.kagoshima-u.ac.jp
Kagoshima University Medical and Dental Hospital
Maruzen pharmaceuticals CO., LTD.
Profit organization
Kagoshima University Medical and Dental Hospital
8-35-1 Sakuragaoka, Kagoshima
099-275-6222
kaku@dent.kagoshima-u.ac.jp
NO
鹿児島大学病院(鹿児島県)
2016 | Year | 07 | Month | 22 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026485
Unpublished
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026485
16
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.
2019 | Year | 07 | Month | 19 | Day |
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.
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).
none
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.
Completed
2016 | Year | 03 | Month | 28 | Day |
2016 | Year | 03 | Month | 26 | Day |
2016 | Year | 07 | Month | 22 | Day |
2018 | Year | 03 | Month | 31 | Day |
2016 | Year | 07 | Month | 01 | Day |
2019 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026485