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

A Clinical Study on the Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients in Taiwan

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05091216

Enrollment

Registered

2021-10-25

Start date

2021-10-01

Completion date

2022-09-06

Last updated

2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hansen's Disease, Leprosy, Plaque, Xerostomia

Keywords

Leprosy, Hansen's disease (HD), traditional Chinese medicine mouthwash, oral health, xerostomia, Plaque Index, PLI

Brief 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.

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.

Interventions

OTHERTraditional 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.

OTHERDilute 50 times of Traditional Chinese Medicine mouthwash

Dilute 50 times of traditional Chinese medicine mouthwash.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Plaque Index, PLI	21 days	Turesky modification of the Quigley-Hein Plaque Index (TQHPI)
Xerostomia questionnaire	21 days	Xerostomia questionnaire, Pai (2001)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026