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WithdrawnNCT03937271Updated Feb 5, 2021

Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome

An observational study in Sjögren's Syndrome, Systemic Lupus Erythematosus and Rheumatoid Arthritis, sponsored by Taipei Veterans General Hospital, Taiwan. Withdrawn at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-05.

Sponsored by Taipei Veterans General Hospital, Taiwan · Observational

Why this study was withdrawn
Leak of research funding
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
0
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Sjögren's Syndrome
  • Systemic Lupus Erythematosus
  • Rheumatoid Arthritis
  • Systemic Sclerosis
  • Ankylosing Spondylitis
  • Dry Eye Syndrome

Keywords

  • Sjögren's syndrome
  • Systemic lupus erythematosus
  • Rheumatoid Arthritis
  • Systemic Sclerosis
  • Ankylosing spondylitis
  • Dry eye syndrome
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

Browse Spondylitis studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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.

Eligibility 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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: Traditional Chinese Medicine tongue diagnosis · Diagnostic Test: Traditional Chinese Medicine pulse diagnosis · Diagnostic Test: Heart rate variability · Diagnostic Test: 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 · Diagnostic Test: Traditional Chinese Medicine tongue diagnosis · Diagnostic Test: Traditional Chinese Medicine pulse diagnosis · Diagnostic Test: Heart rate variability · Diagnostic Test: 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 · Diagnostic Test: Traditional Chinese Medicine tongue diagnosis · Diagnostic Test: Traditional Chinese Medicine pulse diagnosis · Diagnostic Test: Heart rate variability · Diagnostic Test: 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 · Diagnostic Test: Traditional Chinese Medicine tongue diagnosis · Diagnostic Test: Traditional Chinese Medicine pulse diagnosis · Diagnostic Test: Heart rate variability · Diagnostic Test: 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 · Diagnostic Test: Traditional Chinese Medicine tongue diagnosis · Diagnostic Test: Traditional Chinese Medicine pulse diagnosis · Diagnostic Test: Heart rate variability · Diagnostic Test: 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 · Diagnostic Test: Traditional Chinese Medicine tongue diagnosis · Diagnostic Test: Traditional Chinese Medicine pulse diagnosis · Diagnostic Test: Heart rate variability · Diagnostic Test: Schirmer's test

Interventions

  • Diagnostic testTraditional 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 testTraditional 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 testTraditional 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 testHeart 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 testSchirmer'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.

06

What researchers measure

Primary outcomes

  1. TCM pattern

    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).

    Time frame: Five year

  2. TCM tongue diagnosis

    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).

    Time frame: Five year

  3. TCM pulse diagnosis

    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) .

    Time frame: Five year

  4. Heart rate variability (HRV)

    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) .

    Time frame: Five year

07

Study locations

1 site
  • Ching-Mao Chang
    Taipei, Taiwan (r.o.c.) 112, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03937271
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
May 3, 2019
Start date
Apr 1, 2019
Primary completion
May 31, 2019
Completion
Dec 31, 2020
Last update
Feb 5, 2021

Study contacts

Ching-Mao Chang, M.D., Ph.D.
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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