Clinical trial NCT03937271: Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: 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
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

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

Primary outcomes:
measure: TCM pattern
timeFrame: Five year
measure: TCM tongue diagnosis
timeFrame: Five year
measure: TCM pulse diagnosis
timeFrame: Five year
measure: Heart rate variability (HRV)
timeFrame: Five year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ching-Mao Chang
state: Taiwan (r.o.c.)
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ching-Mao Chang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: