A study on the impact of pineapple-extracted ceramide for alleviation of the symptoms of dry mouth

UMIN ID: UMIN000022976

Registered date:22/07/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: xerostomia
• Date of first enrollment: 2016/07/22
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Subjective evaluation of dry mouth at before administration and two weeks after administration
• Secondary Outcome: Moisture level, saliva wetness and number and form of fungiform papilla at before administration and two weeks after administration

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Kagoshima University Medical and Dental Hospital
• Source(s) of Monetary Support: Maruzen pharmaceuticals CO., LTD.