NCT04747288

Objective Measurement With TCM Pattern for AIDDES

Using the Objective Measurement Methods to Evaluate the Association With TCM Pattern and TCM Tongue Diagnosis for Autoimmune Disease and Dry Eye Syndrome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Sjögren's Syndrome
• Systemic Lupus Erythematosus
• Dry Eye Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Traditional Chinese Medicine pattern	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.
DIAGNOSTIC_TEST	Traditional Chinese Medicine tongue diagnosis	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.
DIAGNOSTIC_TEST	Heart rate variability	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.
DIAGNOSTIC_TEST	Schirmer's 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.
DIAGNOSTIC_TEST	Ocular Surface Diseast Index (OSDI)	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).
DIAGNOSTIC_TEST	EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)	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).
DIAGNOSTIC_TEST	36-Item Short Form Survey (SF-36)	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).

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-11-30
• Completion: 2024-12-31
• First posted: 2021-02-10
• Last updated: 2022-12-13

Locations

1 site across 1 country: Taiwan