Evaluation of capsaicin-containing film for improvement of dry mouth in healthy subjects

UMIN ID: UMIN000055652

Registered date:01/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Adult
• Date of first enrollment: 2024/11/01
• Target sample size: 54
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Capsaicin-containing film, 3 sheets a day, 2 weeks
Placebo film, 3 sheets a day, 2 weeks

Outcome(s)

• Primary Outcome: Oral wetness
• Secondary Outcome: Salivary volume Tongue pressure Salivary pH Oral periodontal disease-related bacteria Exhaled gas GOHAI SF-8 Questionnaire

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Subjects diagnosed with oral related diseases such as xerostomia (dry mouth), oral hypofunction. 2) Subjects with hepatic, renal, cardiac, diabetes or other serious diseases. 3) Subjects who judged by a doctor as depression, dementia or mild cognitive impairment. 4) Subjects who have participated in other clinical trials within 84 days prior to the date of consent. 5) Subjects who are judged as unsuitable for this study by the investigator.

Related Information

• Primary Sponsor: Yamada Bee Company, Inc.
• Secondary Sponsor: Research Center for Immunological Analysis, Inc.
• Source(s) of Monetary Support: Yamada Bee Company, Inc.