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Objective Measurement With TCM Pattern for AIDDES

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04747288
Collaborator
(none)
1,800
Enrollment
1
Location
46.9
Anticipated Duration (Months)
38.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Traditional Chinese Medicine pattern
  • Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
  • Diagnostic Test: Heart rate variability
  • Diagnostic Test: Schirmer's test
  • Diagnostic Test: Ocular Surface Diseast Index (OSDI)
  • Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
  • Diagnostic Test: 36-Item Short Form Survey (SF-36)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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). Exclusion Criteria: NA.

Diagnostic Test: Traditional Chinese Medicine pattern
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Heart rate variability
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) 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) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.

Diagnostic Test: Ocular Surface Diseast Index (OSDI)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Ocular Surface Diseast Index (OSDI).

Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).

Diagnostic Test: 36-Item Short Form Survey (SF-36)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the 36-Item Short Form Survey (SF-36).
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 and 1997 revised Systemic lupus erythematosus criteria. Exclusion Criteria: NA.

Diagnostic Test: Traditional Chinese Medicine pattern
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Heart rate variability
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) 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) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.

Diagnostic Test: Ocular Surface Diseast Index (OSDI)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Ocular Surface Diseast Index (OSDI).

Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).

Diagnostic Test: 36-Item Short Form Survey (SF-36)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the 36-Item Short Form Survey (SF-36).
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. Exclusion Criteria: NA.

Diagnostic Test: Traditional Chinese Medicine pattern
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.

Diagnostic Test: Heart rate variability
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) 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) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.

Diagnostic Test: Ocular Surface Diseast Index (OSDI)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Ocular Surface Diseast Index (OSDI).

Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).

Diagnostic Test: 36-Item Short Form Survey (SF-36)
Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the 36-Item Short Form Survey (SF-36).
non AIDDES Healthy Controls

Non AIDDES Healthy Controls were enrolled with 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.

Diagnostic Test: Traditional Chinese Medicine pattern
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.

Outcome Measures

Primary Outcome Measures

  1. TCM pattern [One year]

    TCM pattern is a tool for detecting the constitution among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Dry eye syndrome (DES), and healthy control.

  2. TCM tongue diagnosis [One year]

    TCM tongue diagnosis is a tool for detecting tongue expression among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Dry eye syndrome (DES), and healthy control.

  3. Heart rate variability (HRV) [One year]

    Heart rate variability (HRV) is a tool for detecting ratio between High-frequency (HF) activity and low-frequency (LF) activity among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE),and Dry eye syndrome (DES).

  4. Schirmer's test [One year]

    Schirmer's test is a tool for evaluating aqueous tear production among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).

  5. OSDI(Ocular Surface Disease Index) [One year]

    OSDI is a tool to rate the severity of dry eye disease among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).

  6. ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index) [One year]

    ESSPRI is a tool for evaluating the symptoms of SJS among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).

  7. SF-36(36-Item Short Form Survey ) [One year]

    SF-36 is a tool for evaluating Health-Related Quality of Life among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ching-Mao Chang Taipei Taiwan 112

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Chang Ching-Mao, M.D., Ph.D., Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT04747288
Other Study ID Numbers:
  • 2020-12-014BC
First Posted:
Feb 10, 2021
Last Update Posted:
May 5, 2021
Last Verified:
May 1, 2021
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
Dry Eye Syndrome
Additional relevant MeSH terms:
Sjogren's Syndrome
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lupus Erythematosus, Systemic
Syndrome

Study Results

No Results Posted as of May 5, 2021