Clinical trial NCT04747288: Objective Measurement With TCM Pattern for AIDDES
Official title: Using the Objective Measurement Methods to Evaluate the Association With TCM Pattern and TCM Tongue Diagnosis for Autoimmune Disease and Dry Eye Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sjögren's Syndrome
Systemic Lupus Erythematosus
Dry Eye Syndrome
Keywords: Sjögren's syndrome
Systemic Lupus Erythematosus
Dry Eye Syndrome
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-02-10
Enrollment: 1800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Autoimmune disease (AID) as Sjögren's syndrome (SJS), 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 with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.

Detailed description: Objective: To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.

Method:

This study wants to include the 1000 Autoimmune disease (AID) subjects as 800 Sjögren's syndrome (SJS) and 200 Systemic lupus erythematosus (SLE) for comparing with the 500 Dry eye syndrome (DES) subjects. AID and DES subjects will be enrolled to evaluate at V1 Baseline and follow-up for 6 times evaluation with one month interval during one year. And the non-AID-non-DES healthy control subjects will be also included in our study for comparison with the dry eye syndrome and healthy control. This study want to use objective measurement and questionnaires as TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate AID, DES and healthy control.

Expected Results:

1. To evaluate the difference among TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate between AID and DES.
2. To evaluate the difference among TCM pattern and TCM tongue diagnosis among the AID groups, DES group, and healthy control.

Keyword: Autoimmune disease, Sjögren's syndrome, Systemic lupus erythematosus, Dry eye syndrome, TCM pattern, TCM tongue 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 and 1997 ACR revised Systemic lupus erythematosus 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
* Exclusion Criteria: NA

non AIDDES Healthy Controls

* Inclusion Criteria:

  1. aged between 20 and 75 years
  2. without any Chronic disease
* Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome.

Primary outcomes:
measure: TCM pattern
timeFrame: One year
measure: TCM tongue diagnosis
timeFrame: One year
measure: Heart rate variability (HRV)
timeFrame: One year
measure: Schirmer's test
timeFrame: One year
measure: OSDI(Ocular Surface Disease Index)
timeFrame: One year
measure: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
timeFrame: One year
measure: SF-36(36-Item Short Form Survey )
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ching-Mao Chang
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chang Ching-Mao, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: