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Objective Measurement With TCM Pattern for AIDDES

Recruiting
20 - 75 years of age
Both
Phase N/A

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Overview

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

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

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.

Study details

Sjögren's Syndrome, Systemic Lupus Erythematosus, Dry Eye Syndrome

NCT04747288

Taipei Veterans General Hospital, Taiwan

25 January 2024

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