Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers

August 17, 2021 updated by: Chang Gung Memorial Hospital
The aim of this study is to use a tea-based mouthwash to relieve pain and discomfort in patients with stomatitis and ulcers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 613
        • Chiayi Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

age over 20 years old, male or female

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xerostomia questionnaire (XQ)
Time Frame: 4 weeks
Questionnaires for symptoms relief of dry mouth
4 weeks
Xerostomia Inventory (XI)
Time Frame: 4 weeks
A multi-item approach to measuring dry mouth
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+)
Time Frame: 4 weeks
Immunohistochemistry stain for ACE2 protein
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 26, 2021

Primary Completion (Anticipated)

November 26, 2024

Study Completion (Anticipated)

November 26, 2024

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001919A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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