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Using the Objective Measurement Methods to Evaluate the Association With TCM Pattern and TCM Tongue Diagnosis for Autoimmune Disease and Dry Eye Syndrome
To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.
Objective: To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome. Method: This study wants to include the 1000 Autoimmune disease (AID) subjects as 800 Sjögren's syndrome (SJS) and 200 Systemic lupus erythematosus (SLE) for comparing with the 500 Dry eye syndrome (DES) subjects. AID and DES subjects will be enrolled to evaluate at V1 Baseline and follow-up for 6 times evaluation with one month interval during one year. And the non-AID-non-DES healthy control subjects will be also included in our study for comparison with the dry eye syndrome and healthy control. This study want to use objective measurement and questionnaires as TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate AID, DES and healthy control. Expected Results: 1. To evaluate the difference among TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate between AID and DES. 2. To evaluate the difference among TCM pattern and TCM tongue diagnosis among the AID groups, DES group, and healthy control. Keyword: Autoimmune disease, Sjögren's syndrome, Systemic lupus erythematosus, Dry eye syndrome, TCM pattern, TCM tongue diagnosis.
Age
20 - 75 years
Sex
ALL
Healthy Volunteers
Yes
Ching-Mao Chang
Taipei, Taiwan
Start Date
February 1, 2021
Primary Completion Date
November 30, 2022
Completion Date
December 31, 2024
Last Updated
December 13, 2022
1,800
ESTIMATED participants
Traditional Chinese Medicine pattern
DIAGNOSTIC_TEST
Traditional Chinese Medicine tongue diagnosis
DIAGNOSTIC_TEST
Heart rate variability
DIAGNOSTIC_TEST
Schirmer's test
DIAGNOSTIC_TEST
Ocular Surface Diseast Index (OSDI)
DIAGNOSTIC_TEST
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
DIAGNOSTIC_TEST
36-Item Short Form Survey (SF-36)
DIAGNOSTIC_TEST
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
NCT06647069
NCT07371468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06333483