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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05010928
Other study ID # 202001919A3
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date August 26, 2021
Est. completion date November 26, 2024

Study information

Verified date August 2021
Source Chang Gung Memorial Hospital
Contact Ming-Shao Tsai, M.D.
Phone +886 5 3621000
Email b87401061@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 26, 2024
Est. primary completion date November 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: age over 20 years old, male or female Exclusion Criteria: patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Chiayi chang Gung Memorial Hospital Chiayi City

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Xerostomia questionnaire (XQ) Questionnaires for symptoms relief of dry mouth 4 weeks
Primary Xerostomia Inventory (XI) A multi-item approach to measuring dry mouth 4 weeks
Secondary Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+) Immunohistochemistry stain for ACE2 protein 4 weeks
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