Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome

Withdrawn

• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Systemic Sclerosis; Sjögren's Syndrome; Ankylosing Spondylitis; Dry Eye Syndrome
• Interventions: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test

• Registration Number: NCT03937271
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Primary Completion: 2019-05-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sjögren's syndrome	Schirmer's test	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)
Systemic lupus erythematosus	Traditional Chinese Medicine tongue diagnosis	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
Systemic lupus erythematosus	Heart rate variability	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
Rheumatoid Arthritis	Traditional Chinese Medicine pattern	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
Rheumatoid Arthritis	Traditional Chinese Medicine pulse diagnosis	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
Rheumatoid Arthritis	Heart rate variability	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
Systemic Sclerosis	Traditional Chinese Medicine tongue diagnosis	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
Systemic lupus erythematosus	Traditional Chinese Medicine pulse diagnosis	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
Sjögren's syndrome	Traditional Chinese Medicine tongue diagnosis	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)
Sjögren's syndrome	Traditional Chinese Medicine pulse diagnosis	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)
Systemic Sclerosis	Heart rate variability	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
Sjögren's syndrome	Traditional Chinese Medicine pattern	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)
Sjögren's syndrome	Heart rate variability	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)
Rheumatoid Arthritis	Schirmer's test	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
Dry eye syndrome	Traditional Chinese Medicine tongue diagnosis	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
Systemic lupus erythematosus	Traditional Chinese Medicine pattern	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
Systemic Sclerosis	Traditional Chinese Medicine pulse diagnosis	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
Ankylosing spondylitis	Traditional Chinese Medicine tongue diagnosis	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
Ankylosing spondylitis	Traditional Chinese Medicine pulse diagnosis	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
Systemic lupus erythematosus	Schirmer's test	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
Rheumatoid Arthritis	Traditional Chinese Medicine tongue diagnosis	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
Systemic Sclerosis	Traditional Chinese Medicine pattern	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
Ankylosing spondylitis	Heart rate variability	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
Dry eye syndrome	Traditional Chinese Medicine pattern	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
Systemic Sclerosis	Schirmer's test	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
Dry eye syndrome	Traditional Chinese Medicine pulse diagnosis	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
Dry eye syndrome	Schirmer's test	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
Ankylosing spondylitis	Traditional Chinese Medicine pattern	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
Ankylosing spondylitis	Schirmer's test	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
Dry eye syndrome	Heart rate variability	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

Primary Outcome Measures

Name	Time	Method
TCM tongue diagnosis	Five year	TCM tongue diagnosis is a tool for detecting tongue expression among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES).
TCM pattern	Five year	TCM pattern is a tool for detecting the constitution among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES).
TCM pulse diagnosis	Five year	TCM pulse diagnosis is a tool for detecting pulse of radial artery among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES) .
Heart rate variability (HRV)	Five year	HRV is a tool for detecting the ratio between High-frequency (HF) activity and low-frequency (LF) activity. among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES) .

Trial Locations

Locations (1)

Ching-Mao Chang; 🇨🇳 Taipei, Taiwan (r.o.c.), Taiwan