The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients

NCT ID: NCT05091216

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-09-06

Brief Summary

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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

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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

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Leprosy Hansen's Disease Xerostomia Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Traditional Chinese Medicine Mouthwash Group

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.

Group Type EXPERIMENTAL

Traditional Chinese Medicine mouthwash

Intervention Type OTHER

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 Mouthwash Group

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.

Group Type ACTIVE_COMPARATOR

Dilute 50 times of Traditional Chinese Medicine mouthwash

Intervention Type OTHER

Dilute 50 times of traditional Chinese medicine mouthwash.

Interventions

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Traditional Chinese Medicine mouthwash

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.

Intervention Type OTHER

Dilute 50 times of Traditional Chinese Medicine mouthwash

Dilute 50 times of traditional Chinese medicine mouthwash.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lo-Sheng Sanatorium

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hsu Wei Hung

Director of chinese medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei-Hung Hsu

Role: PRINCIPAL_INVESTIGATOR

Lo-Sheng Sanatorium

Locations

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Lo-Sheng Sanatorium

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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TH-IRB-0021-0012

Identifier Type: -

Identifier Source: org_study_id

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