Objective Measurement With TCM Pattern for AIDDES

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Dry Eye Syndrome; Sjögren's Syndrome; Systemic Lupus Erythematosus

Treatments: Diagnostic Test: Heart rate variability; Diagnostic Test: 36-Item Short Form Survey (SF-36); Diagnostic Test: Schirmer's test; Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: Ocular Surface Diseast Index (OSDI); Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT04747288

2020-12-014BC

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Sjögren's syndrome

• 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

• Inclusion Criteria:

  1. aged between 20 and 75 years
  2. fulfilled the 1982 and 1997 ACR revised Systemic lupus erythematosus criteria

• Exclusion Criteria: NA

Dry eye syndrome

• Inclusion Criteria:

  1. aged between 20 and 75 years
  2. Schirmer's test less than 10 mm/5 min

• Exclusion Criteria: NA

non AIDDES Healthy Controls

• 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.

Trial design

1,800 participants in 4 patient groups

Sjögren's syndrome

Description:

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.

Treatment:

Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

Diagnostic Test: Heart rate variability

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: 36-Item Short Form Survey (SF-36)

Diagnostic Test: Ocular Surface Diseast Index (OSDI)

Systemic lupus erythematosus

Description:

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.

Treatment:

Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

Diagnostic Test: Heart rate variability

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: 36-Item Short Form Survey (SF-36)

Diagnostic Test: Ocular Surface Diseast Index (OSDI)

Dry eye syndrome

Description:

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.

Treatment:

Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

Diagnostic Test: Heart rate variability

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: 36-Item Short Form Survey (SF-36)

Diagnostic Test: Ocular Surface Diseast Index (OSDI)

non AIDDES Healthy Controls

Description:

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.

Treatment:

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Traditional Chinese Medicine pattern