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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:
Keyword: Autoimmune disease, Sjögren's syndrome, Systemic lupus erythematosus, Dry eye syndrome, TCM pattern, TCM tongue diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sjögren's syndrome | 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. |
| |
| Systemic lupus erythematosus | 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. |
| |
| Dry eye syndrome | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese Medicine pattern | Diagnostic Test | 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. |
| 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 ) |
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Sjögren's syndrome
Inclusion Criteria:
Exclusion Criteria: NA
Systemic lupus erythematosus
Inclusion Criteria:
Exclusion Criteria: NA
Dry eye syndrome
Inclusion Criteria:
Exclusion Criteria: NA
non AIDDES Healthy Controls
Inclusion Criteria:
Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome.
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Autoimmune disease (AID) as Sjögren's syndrome (SJS), and Dry eye syndrome (DES) subjects were screened in the ophthalmology outpatient departments, rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Ching-Mao, M.D., Ph.D. | Contact | 886-28757453 Ext. 333 | magicbjp@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Ching-Mao, M.D., Ph.D. | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ching-Mao Chang | Recruiting | Taipei | 112 | Taiwan |
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| non AIDDES Healthy Controls | 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. |
|
|
| Traditional Chinese Medicine tongue diagnosis | Diagnostic Test | 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. |
|
| Heart rate variability | Diagnostic Test | 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. |
|
| Schirmer's test | Diagnostic Test | 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. |
|
| Ocular Surface Diseast Index (OSDI) | Diagnostic Test | 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). |
|
| EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) | Diagnostic Test | 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). |
|
| 36-Item Short Form Survey (SF-36) | Diagnostic Test | 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). |
|
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 |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D008180 | Lupus Erythematosus, Systemic |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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