Objective Measurement With TCM Pattern for AIDDES

Study Overview
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Brief Summary
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To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.

Detailed Description
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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: 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. 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.

Official Title
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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

Conditions
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Sjögren's Syndrome, Systemic Lupus Erythematosus, Dry Eye Syndrome

Intervention / Treatment
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* Diagnostic Test: 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)


Participation Criteria
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Eligibility Criteria
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Sjögren's syndrome Inclusion Criteria: aged between 20 and 75 years fulfilled the 2002 American-European Consensus Criteria for SS (AECG) Exclusion Criteria: NA Systemic lupus erythematosus Inclusion Criteria: aged between 20 and 75 years fulfilled the 1982 and 1997 ACR revised Systemic lupus erythematosus criteria Exclusion Criteria: NA Dry eye syndrome Inclusion Criteria: aged between 20 and 75 years Schirmer's test less than 10 mm/5 min Exclusion Criteria: NA non AIDDES Healthy Controls Inclusion Criteria: aged between 20 and 75 years without any Chronic disease Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sjögren's syndrome<br>Sjögren's syndrome patients were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 20 and 75 years; (2) fulfilled the 2002 American-European Consensus Criteria for SS (AECG). Exclusion Criteria: NA. | Diagnostic Test: Traditional Chinese Medicine pattern<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.<br>Diagnostic Test: Traditional Chinese Medicine tongue diagnosis<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.<br>Diagnostic Test: Heart rate variability<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Heart rate variability.<br>Diagnostic Test: Schirmer's test<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.<br>Diagnostic Test: Ocular Surface Diseast Index (OSDI)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Ocular Surface Diseast Index (OSDI).<br>Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).<br>Diagnostic Test: 36-Item Short Form Survey (SF-36)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the 36-Item Short Form Survey (SF-36).<br>|
| Systemic lupus erythematosus<br>Systemic lupus erythematosus patients were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 20 and 75 years; (2) fulfilled the 1982 and 1997 revised Systemic lupus erythematosus criteria. Exclusion Criteria: NA. | Diagnostic Test: Traditional Chinese Medicine pattern<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.<br>Diagnostic Test: Traditional Chinese Medicine tongue diagnosis<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.<br>Diagnostic Test: Heart rate variability<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Heart rate variability.<br>Diagnostic Test: Schirmer's test<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.<br>Diagnostic Test: Ocular Surface Diseast Index (OSDI)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Ocular Surface Diseast Index (OSDI).<br>Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).<br>Diagnostic Test: 36-Item Short Form Survey (SF-36)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the 36-Item Short Form Survey (SF-36).<br>|
| Dry eye syndrome<br>Dry eye syndrome patients were screened in the ophthalmology outpatient departments, rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 20 and 75 years; (2) Schirmer's test less than 10 mm/5 min. Exclusion Criteria: NA. | Diagnostic Test: Traditional Chinese Medicine pattern<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.<br>Diagnostic Test: Traditional Chinese Medicine tongue diagnosis<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.<br>Diagnostic Test: Heart rate variability<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Heart rate variability.<br>Diagnostic Test: Schirmer's test<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.<br>Diagnostic Test: Ocular Surface Diseast Index (OSDI)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Ocular Surface Diseast Index (OSDI).<br>Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).<br>Diagnostic Test: 36-Item Short Form Survey (SF-36)<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the 36-Item Short Form Survey (SF-36).<br>|
| non AIDDES Healthy Controls<br>Non AIDDES Healthy Controls were enrolled with inclusion criteria: (1) aged between 20 and 75 years; (2) without any Chronic disease. Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome. | Diagnostic Test: Traditional Chinese Medicine pattern<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.<br>Diagnostic Test: Traditional Chinese Medicine tongue diagnosis<br>* Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCM pattern | TCM pattern is a tool for detecting the constitution among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Dry eye syndrome (DES), and healthy control. | One year | 
| TCM tongue diagnosis | TCM tongue diagnosis is a tool for detecting tongue expression among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Dry eye syndrome (DES), and healthy control. | One year | 
| Heart rate variability (HRV) | Heart rate variability (HRV) is a tool for detecting ratio between High-frequency (HF) activity and low-frequency (LF) activity among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE),and Dry eye syndrome (DES). | One year | 
| Schirmer's test | Schirmer's test is a tool for evaluating aqueous tear production among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES). | One year | 
| OSDI(Ocular Surface Disease Index) | OSDI is a tool to rate the severity of dry eye disease among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES). | One year | 
| ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index) | ESSPRI is a tool for evaluating the symptoms of SJS among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES). | One year | 
| SF-36(36-Item Short Form Survey ) | SF-36 is a tool for evaluating Health-Related Quality of Life among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES). | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjögren's syndrome, Systemic Lupus Erythematosus, Dry Eye Syndrome