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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome

Clinicaltrials.gov identifier NCT03937271

Recruitment Status Withdrawn (Leak of research funding)

First Posted May 3, 2019

Last update posted February 5, 2021

Study Description

Brief summary:

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

  • Condition or Disease:Systemic Lupus Erythematosus
    Rheumatoid Arthritis
    Systemic Sclerosis
    Ankylosing Spondylitis
    Dry Eye Syndrome
    Sjögren's Syndrome
  • Intervention/Treatment: 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
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Observational Model: Case-Control
  • Time Perspective: Cross-Sectional
  • Official Title: Using the Objective Measurement Methods and TCM Questionnaire to Explore the Association Among TCM Pattern, TCM Tongue Diagnosis and TCM Pulse Diagnosis for Autoimmune Disease and Dry Eye Syndrome
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: December 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Ankylosing spondylitis
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
Diagnostic Test: Traditional Chinese Medicine pattern
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 will take the Traditional Chinese Medicine pattern.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
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 will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
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 will take the Traditional Chinese Medicine pulse diagnosis.

Diagnostic Test: Heart rate variability
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 will take the Heart rate variability.

Diagnostic Test: Schirmer's test
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 will take the Schirmer's test.
: 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
Diagnostic Test: Traditional Chinese Medicine pattern
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 will take the Traditional Chinese Medicine pattern.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
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 will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
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 will take the Traditional Chinese Medicine pulse diagnosis.

Diagnostic Test: Heart rate variability
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 will take the Heart rate variability.

Diagnostic Test: Schirmer's test
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 will take the Schirmer's test.
: Rheumatoid Arthritis
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
Diagnostic Test: Traditional Chinese Medicine pattern
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 will take the Traditional Chinese Medicine pattern.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
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 will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
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 will take the Traditional Chinese Medicine pulse diagnosis.

Diagnostic Test: Heart rate variability
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 will take the Heart rate variability.

Diagnostic Test: Schirmer's test
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 will take the Schirmer's test.
: 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)
Diagnostic Test: Traditional Chinese Medicine pattern
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 will take the Traditional Chinese Medicine pattern.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
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 will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
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 will take the Traditional Chinese Medicine pulse diagnosis.

Diagnostic Test: Heart rate variability
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 will take the Heart rate variability.

Diagnostic Test: Schirmer's test
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 will take the Schirmer's test.
: Systemic Sclerosis
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
Diagnostic Test: Traditional Chinese Medicine pattern
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 will take the Traditional Chinese Medicine pattern.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
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 will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
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 will take the Traditional Chinese Medicine pulse diagnosis.

Diagnostic Test: Heart rate variability
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 will take the Heart rate variability.

Diagnostic Test: Schirmer's test
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 will take the Schirmer's test.
: 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 revised Systemic lupus erythematosus criteria
Diagnostic Test: Traditional Chinese Medicine pattern
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 will take the Traditional Chinese Medicine pattern.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
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 will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
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 will take the Traditional Chinese Medicine pulse diagnosis.

Diagnostic Test: Heart rate variability
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 will take the Heart rate variability.

Diagnostic Test: Schirmer's test
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 will take the Schirmer's test.
Outcome Measures
  • Primary Outcome Measures: 1. TCM pattern [ Time Frame: 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).
  • 2. TCM tongue diagnosis [ Time Frame: 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).
  • 3. TCM pulse diagnosis [ Time Frame: 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) .
  • 4. Heart rate variability (HRV) [ Time Frame: 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) .
Eligibility Criteria
  • Ages Eligible for Study: 20 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), 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.
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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

Principal Investigator: Ching-Mao Chang, M.D., Ph.D. Taipei Veterans General Hospital, Taiwan

More Information
  • Responsible Party: Taipei Veterans General Hospital, Taiwan
  • ClinicalTrials.gov Identifier: NCT03937271 History of Changes
  • Other Study ID Numbers: 2018-10-003AC
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: February 5, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Taipei Veterans General Hospital, Taiwan: Systemic Sclerosis
    Sjögren's syndrome
    Rheumatoid Arthritis
    Ankylosing spondylitis
    Dry eye syndrome
    Systemic lupus erythematosus
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic
    Scleroderma, Systemic
    Dry Eye Syndromes
    Syndrome
    Sclerosis
    Autoimmune Diseases
    Spondylitis
    Spondylitis, Ankylosing
    Scleroderma, Diffuse
    Arthritis, Rheumatoid
    Keratoconjunctivitis Sicca
    Arthritis
    Sjogren's Syndrome