NCT05010928

Brief Summary

The aim of this study is to use a tea-based mouthwash to relieve pain and discomfort in patients with stomatitis and ulcers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

August 26, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2024

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

3.3 years

First QC Date

August 9, 2021

Last Update Submit

August 17, 2021

Conditions

Stomatitis

Keywords

Stomatitis; oral ulcers; oral mucosa; tea; mouthwash

Outcome Measures

Primary Outcomes (2)

  • Xerostomia questionnaire (XQ)

    Questionnaires for symptoms relief of dry mouth

    4 weeks

  • Xerostomia Inventory (XI)

    A multi-item approach to measuring dry mouth

    4 weeks

Secondary Outcomes (1)

  • Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+)

    4 weeks

Study Arms (2)

Tea mouthwash group

EXPERIMENTAL
Combination Product: mouthwash with tea

Control group

NO INTERVENTION

Interventions

mouthwash with teaCOMBINATION_PRODUCT

Using tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis.

Tea mouthwash group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 20 years old, male or female

You may not qualify if:

  • patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiayi chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

Location

MeSH Terms

Conditions

StomatitisOral Ulcer

Interventions

MouthwashesTea

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and AgriculturePlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Ming-Shao Tsai, M.D.

CONTACT

+886 5 3621000b87401061@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 18, 2021

Study Start

August 26, 2021

Primary Completion

November 26, 2024

Study Completion

November 26, 2024

Last Updated

August 18, 2021

Record last verified: 2021-08

Locations

TW(1)