LeprosyNCT05091216
The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients
A study testing Traditional Chinese Medicine mouthwash and Dilute 50 times of Traditional Chinese Medicine mouthwash in people with Leprosy and Hansen's Disease, run by Lo-Sheng Sanatorium at 1 site in Taiwan.
Trial summary
The purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Leprosy, Hansen's Disease, Xerostomia
- What is being tested?
- Traditional Chinese Medicine mouthwash and Dilute 50 times of Traditional Chinese Medicine mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 6 Sep 2022
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of Lo-Sheng sanatorium of the Ministry of Health and Welfare, Taiwan
- Compliant with the presence of more than four teeth in each of the upper and lower four regions
- Those who have not used antibiotics and mouthwash two months before the test
Who cannot join
- Moderate to severe dementia
- CDR (Clinical Dementia Assessment Scale) is greater than or equal to 2 points or more
- Those with a score of less than 17 on the MMSE Simple Mind Scale
- Nasogastric Tube Inserters
- Those who are allergic to mouthwash
- Those who are on course of antibiotics and steroids
- Those who have had dental cleansing within one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study on the Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients in Taiwan
The purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism.
Read the detailed description
The study will recruit 58 patients who are hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare. Investigators will use xerostomia questionnaire and PLI examination to collect the subject's data. Separate subjects in to two group randomly. The control group will use the traditional Chinese medicine mouthwash, and the other group will use the dilute 50 times of traditional Chinese medicine mouthwash.
Every 7 days will record the PLI value and conduct a xerostomia questionnaire, until 21 days.
- Conditions
- Leprosy, Hansen's Disease, Xerostomia, Plaque
- Being tested
- Traditional Chinese Medicine mouthwash, Dilute 50 times of Traditional Chinese Medicine mouthwash
- Keywords
- Leprosy, Hansen's disease (HD), traditional Chinese medicine mouthwash, oral health, xerostomia, Plaque Index, PLI
- Medical subject headings
- Leprosy, Xerostomia, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine mouthwashOther
The mouthwash used in this test is based on the records of past traditional Chinese medicine classics and the existing antibacterial experimental evidence. The selected medicinal materials are honeysuckle, scutellaria, peppermint, licorice, and rhizome.
Dilute 50 times of Traditional Chinese Medicine mouthwashOther
Dilute 50 times of traditional Chinese medicine mouthwash.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine Mouthwash Group | Experimental | The subjects use traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire. Receives: Other: Traditional Chinese Medicine mouthwash |
| Dilute 50 times of Traditional Chinese Medicine Mouthwash Group | Active comparator | The subjects use dilute 50 times traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire. Receives: Other: Dilute 50 times of Traditional Chinese Medicine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index, PLI
Turesky modification of the Quigley-Hein Plaque Index (TQHPI)
Measured: 21 days
Xerostomia questionnaire
Xerostomia questionnaire, Pai (2001)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Oct 2021
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo-Sheng Sanatorium
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hsu Wei Hung, Lo-Sheng Sanatorium
- Investigators
- Wei-Hung Hsu, Principal investigator, Lo-Sheng Sanatorium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091216
- Sponsor's protocol ID
- TH-IRB-0021-0012
- Status last verified
- Mar 2024
- First submitted
- 29 Sep 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients in Taiwan
- ClinicalTrials.gov ID
- NCT05091216
- Acronym / sponsor ID
- TH-IRB-0021-0012
- Conditions
- Leprosy, Hansen's Disease, Xerostomia, Plaque
- Keywords
- Leprosy, Hansen's disease (HD), traditional Chinese medicine mouthwash, oral health, xerostomia, Plaque Index, PLI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Lo-Sheng SanatoriumOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 25 Oct 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 purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism.
Detailed description
The study will recruit 58 patients who are hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare. Investigators will use xerostomia questionnaire and PLI examination to collect the subject's data. Separate subjects in to two group randomly. The control group will use the traditional Chinese medicine mouthwash, and the other group will use the dilute 50 times of traditional Chinese medicine mouthwash.
Every 7 days will record the PLI value and conduct a xerostomia questionnaire, until 21 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine Mouthwash Group | Experimental | Other: Traditional Chinese Medicine mouthwashThe subjects use traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire. |
| Dilute 50 times of Traditional Chinese Medicine Mouthwash Group | Active comparator | Other: Dilute 50 times of Traditional Chinese Medicine mouthwashThe subjects use dilute 50 times traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Residents of Lo-Sheng sanatorium of the Ministry of Health and Welfare, Taiwan
- Compliant with the presence of more than four teeth in each of the upper and lower four regions
- Those who have not used antibiotics and mouthwash two months before the test
Key exclusion criteria (7 listed)
- Moderate to severe dementia
- CDR (Clinical Dementia Assessment Scale) is greater than or equal to 2 points or more
- Those with a score of less than 17 on the MMSE Simple Mind Scale
- Nasogastric Tube Inserters
- Those who are allergic to mouthwash
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 |
|---|---|---|
| Traditional Chinese Medicine mouthwashThe mouthwash used in this test is based on the records of past traditional Chinese medicine classics and the existing antibacterial experimental evidence. The selected medicinal materials are honeysuckle, scutellaria, peppermint, licorice, and rhizome. | Other | Traditional Chinese Medicine Mouthwash Group |
| Dilute 50 times of Traditional Chinese Medicine mouthwashDilute 50 times of traditional Chinese medicine mouthwash. | Other | Dilute 50 times of Traditional Chinese Medicine Mouthwash Group |
Primary outcome
Plaque Index, PLI
Time frame: 21 days
Turesky modification of the Quigley-Hein Plaque Index (TQHPI)
Xerostomia questionnaire
Time frame: 21 days
Xerostomia questionnaire, Pai (2001)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Wei-Hung Hsu principal investigator
Lo-Sheng Sanatorium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine mouthwash and Dilute 50 times of Traditional Chinese Medicine mouthwash in people with Leprosy and Hansen's Disease, run by Lo-Sheng Sanatorium 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 13 Mar 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index, PLI (time frame: 21 days). 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 13 Mar 2024.