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Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937271
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Sjögren's Syndrome Systemic Lupus Erythematosus Rheumatoid Arthritis Systemic Sclerosis Ankylosing Spondylitis Dry Eye Syndrome 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

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

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Study Type : Observational
Estimated Enrollment : 300 participants
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 1, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2023


Group/Cohort Intervention/treatment
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 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.

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.

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.

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.




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) .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937271


Locations
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Taiwan
Ching-Mao Chang
Taipei, Taiwan (r.o.c.), Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Ching-Mao Chang, M.D., Ph.D. Taipei Veterans General Hospital, Taiwan
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03937271    
Other Study ID Numbers: 2018-10-003AC
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Sjögren's syndrome
Systemic lupus erythematosus
Rheumatoid Arthritis
Systemic Sclerosis
Ankylosing spondylitis
Dry eye syndrome
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Sjogren's Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Autoimmune Diseases
Syndrome
Sclerosis
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Bone Diseases, Infectious
Infection
Bone Diseases