StomatitisPhase 2NCT05010928
Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
A Phase 2 study testing mouthwash with tea in people with Stomatitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stomatitis
- What is being tested?
- mouthwash with tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2021to 26 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 20 years old, male or female
Who cannot join
- patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chiayi chang Gung Memorial Hospital
Chiayi City, 613
Ming-Shao Tsai, M.D., +886 5 3621000 ext. 2076, b87401061@gmail.com
About this study
The aim of this study is to use a tea-based mouthwash to relieve pain and discomfort in patients with stomatitis and ulcers.
Read the 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.
- Conditions
- Stomatitis
- Being tested
- mouthwash with tea
- Keywords
- Stomatitis; oral ulcers; oral mucosa; tea; mouthwash
- Medical subject headings
- Stomatitis, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouthwash with teaCombination product
Using tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis.
| Study group | Role | What they receive |
|---|---|---|
| Tea mouthwash group | Experimental | Not described Receives: Combination Product: mouthwash with tea |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia questionnaire (XQ)
Questionnaires for symptoms relief of dry mouth
Measured: 4 weeks
Xerostomia Inventory (XI)
A multi-item approach to measuring dry mouth
Measured: 4 weeks
Secondary outcomes (1)
Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+)
Immunohistochemistry stain for ACE2 protein
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start26 Aug 2021 (estimated)
- Primary completion26 Nov 2024 (estimated)
- Study completion26 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010928
- Sponsor's protocol ID
- 202001919A3
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
- ClinicalTrials.gov ID
- NCT05010928
- Acronym / sponsor ID
- 202001919A3
- Conditions
- Stomatitis
- Keywords
- Stomatitis; oral ulcers; oral mucosa; tea; mouthwash
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 26 Aug 2021 (estimated)
- Primary completion
- 26 Nov 2024 (estimated)
- Study completion
- 26 Nov 2024 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tea mouthwash group | Experimental | Combination Product: mouthwash with tea |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age over 20 years old, male or female
Key exclusion criteria (1 listed)
- patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouthwash with teaUsing tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis. | Combination product | Tea mouthwash group |
Primary outcome
Xerostomia questionnaire (XQ)
Time frame: 4 weeks
Questionnaires for symptoms relief of dry mouth
Xerostomia Inventory (XI)
Time frame: 4 weeks
A multi-item approach to measuring dry mouth
1 secondary outcome
Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mouthwash with tea in people with Stomatitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Shao Tsai, M.D. (+886 5 3621000 ext. 2076, b87401061@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia questionnaire (XQ) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021; AzTrials last refreshed its copy on 2 Nov 2026.