Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05010928

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stomatitis	Combination Product: mouthwash with tea	Phase 2

Detailed Description

The objective of this study is to use tea as a base, supplemented with licorice to reduce bitterness and astringency, to make mouthwash, and use tea's antioxidant and anti-inflammatory properties to relieve the pain and discomfort of stomatitis and ulcer patients. This study will observe the difference between saliva and oral mucosal cells before and after treatment, to find the mechanism of effective treatment of stomatitis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers

Anticipated Study Start Date :

Aug 26, 2021

Anticipated Primary Completion Date :

Nov 26, 2024

Anticipated Study Completion Date :

Nov 26, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tea mouthwash group	Combination Product: mouthwash with tea Using tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis.
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: Tea mouthwash group

Combination Product: mouthwash with tea

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

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

Xerostomia questionnaire (XQ) [4 weeks]
Questionnaires for symptoms relief of dry mouth
Xerostomia Inventory (XI) [4 weeks]
A multi-item approach to measuring dry mouth

Secondary Outcome Measures

Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+) [4 weeks]
Immunohistochemistry stain for ACE2 protein

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age over 20 years old, male or female

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chiayi chang Gung Memorial Hospital	Chiayi City		Taiwan	613

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05010928

Other Study ID Numbers:

202001919A3

First Posted:

Aug 18, 2021

Last Update Posted:

Aug 18, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chang Gung Memorial Hospital

Stomatitis; oral ulcers; oral mucosa; tea; mouthwash

Additional relevant MeSH terms:

Stomatitis

Oral Ulcer

Study Results

No Results Posted as of Aug 18, 2021