Brief Summary

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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,800

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.9 years study duration

Study Start

First participant enrolled

February 1, 2021

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

February 9, 2021

Last Update Submit

December 11, 2022

Conditions

Sjögren's Syndrome Systemic Lupus Erythematosus Dry Eye Syndrome

Keywords

Sjögren's syndromeSystemic Lupus ErythematosusDry Eye Syndrome

Outcome Measures

Primary Outcomes (7)

TCM pattern
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.
One year
TCM tongue diagnosis
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.
One year
Heart rate variability (HRV)
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).
One year
Schirmer's test
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).
One year
OSDI(Ocular Surface Disease Index)
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).
One year
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
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).
One year
SF-36(36-Item Short Form Survey )
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).
One year

Study Arms (4)

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 patternDiagnostic Test: Traditional Chinese Medicine tongue diagnosisDiagnostic Test: Heart rate variabilityDiagnostic Test: Schirmer's testDiagnostic 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)

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.

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.

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 patternDiagnostic Test: Traditional Chinese Medicine tongue diagnosis

Interventions

Traditional Chinese Medicine patternDIAGNOSTIC_TEST

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.

Dry eye syndromeSjögren's syndromeSystemic lupus erythematosusnon AIDDES Healthy Controls

Traditional Chinese Medicine tongue diagnosisDIAGNOSTIC_TEST

Dry eye syndromeSjögren's syndromeSystemic lupus erythematosusnon AIDDES Healthy Controls

Heart rate variabilityDIAGNOSTIC_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 Heart rate variability.