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NCT05091216 Clinical Trial

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

Xerostomia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05091216
Other study ID # TH-IRB-0021-0012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date September 6, 2022

Study information
Verified date March 2024
Source Lo-Sheng Sanatorium
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date September 6, 2022
Est. primary completion date September 6, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.
• Dilute 50 times of Traditional Chinese Medicine mouthwash
Dilute 50 times of traditional Chinese medicine mouthwash.

Locations
Country Name City State
Taiwan Lo-Sheng Sanatorium Taoyuan City

Sponsors (1)
Lead Sponsor Collaborator
Lo-Sheng Sanatorium

Country where clinical trial is conducted

Taiwan, 

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