Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome

Taipei Veterans General Hospital

Status: Withdrawn

Conditions: Systemic Sclerosis; Dry Eye Syndrome; Sjögren's Syndrome; Ankylosing Spondylitis; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Heart rate variability; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Schirmer's test; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT03937271

2018-10-003AC

Details and patient eligibility

About

To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome

Full description

Objective: To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome

Method:

This study wants to establish the objective measurement of Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects. And the investigators want to use the objective measurement tools to explore the association of TCM pattern, heart rate variability (HRV), TCM tongue diagnosis and TCM pulse diagnosis among at least 50 each AID group subjects and at least 50 DES subjects.

Expected Results:

1. To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each AID groups.
2. To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each DES groups.
3. To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis among the AID groups and DES group.

Keyword: Autoimmune disease, Dry eye syndrome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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 ACR revised Systemic lupus erythematosus criteria Exclusion Criteria: NA

Rheumatoid Arthritis

Inclusion Criteria:

• (1) aged between 20 and 75 years
• (2) fulfilled the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria Exclusion Criteria: NA

Systemic Sclerosis

Inclusion Criteria:

• (1) aged between 20 and 75 years
• (2) fulfilled the 1980 ACR eSystemic Sclerosis criteria Exclusion Criteria: NA

Ankylosing spondylitis

Inclusion Criteria:

• (1) aged between 20 and 75 years
• (2) fulfilled the 1984 Ankylosing spondylitis Modified New York 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

Trial design

0 participants in 6 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)

Treatment:

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Heart rate variability

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 revised Systemic lupus erythematosus criteria

Treatment:

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Heart rate variability

Rheumatoid Arthritis

Description:

Rheumatoid Arthritis 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 2010 ACR/EULAR Rheumatoid Arthritis classification criteria

Treatment:

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Heart rate variability

Systemic Sclerosis

Description:

Systemic Sclerosis 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 1980 ACR eSystemic Sclerosis criteria

Treatment:

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Heart rate variability

Ankylosing spondylitis

Description:

Ankylosing spondylitis 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 1984 Ankylosing spondylitis Modified New York criteria

Treatment:

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Heart rate variability

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

Treatment:

Diagnostic Test: Schirmer's test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Diagnostic Test: Heart rate variability