Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers | NCT05010928

Studies
Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers

NCT05010928

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Aug 18, 2021Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Stomatitis

Interventions

mouthwash with tea

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2021Estimated

Primary Completion Date

Nov 26, 2024Estimated

Completion Date

Nov 26, 2024Estimated

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Aug 17, 2021

First Posted Date

Aug 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2021

Last Update Posted Date

Aug 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tea mouthwash group	Experimental		Combination Product: mouthwash with tea
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mouthwash with tea	Combination Product	Using tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis.	Tea mouthwash group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ming-Shao Tsai, M.D.	Contact	+886 5 3621000	2076	b87401061@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chiayi chang Gung Memorial Hospital		Chiayi City		613	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D013280	Stomatitis
D019226	Oral Ulcer

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009067	Mouthwashes
D013662	Tea

Ancestor Terms

ID	Term
D001697	Biomedical and Dental Materials
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D003358	Cosmetics

Browse Leaves

Not provided

Browse Branches

Not provided