Back to resultsUsing Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
Primary Purpose
Stomatitis
Status
Not yet recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
mouthwash with tea
Sponsored by
About this trial
This is an interventional treatment trial for Stomatitis focused on measuring Stomatitis; oral ulcers; oral mucosa; tea; mouthwash
Eligibility Criteria
Inclusion Criteria:
age over 20 years old, male or female
Exclusion Criteria:
patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.
Sites / Locations
- Chiayi chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tea mouthwash group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Xerostomia questionnaire (XQ)
Questionnaires for symptoms relief of dry mouth
Xerostomia Inventory (XI)
A multi-item approach to measuring dry mouth
Secondary Outcome Measures
Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+)
Immunohistochemistry stain for ACE2 protein
Full Information
NCT ID
NCT05010928
First Posted
August 9, 2021
Last Updated
August 17, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05010928
Brief Title
Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
Official Title
Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 26, 2021 (Anticipated)
Primary Completion Date
November 26, 2024 (Anticipated)
Study Completion Date
November 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomatitis
Keywords
Stomatitis; oral ulcers; oral mucosa; tea; mouthwash
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tea mouthwash group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Combination Product
Intervention Name(s)
mouthwash with tea
Intervention Description
Using tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis.
Primary Outcome Measure Information:
Title
Xerostomia questionnaire (XQ)
Description
Questionnaires for symptoms relief of dry mouth
Time Frame
4 weeks
Title
Xerostomia Inventory (XI)
Description
A multi-item approach to measuring dry mouth
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+)
Description
Immunohistochemistry stain for ACE2 protein
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age over 20 years old, male or female
Exclusion Criteria:
patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Shao Tsai, M.D.
Phone
+886 5 3621000
Ext
2076
Email
b87401061@gmail.com
Facility Information:
Facility Name
Chiayi chang Gung Memorial Hospital
City
Chiayi City
ZIP/Postal Code
613
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Shao Tsai, M.D.
Phone
+886 5 3621000
Ext
2076
Email
b87401061@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
We'll reach out to this number within 24 hrs