Objective Measurement With TCM Pattern for AIDDES

Using the Objective Measurement Methods to Evaluate the Association With TCM Pattern and TCM Tongue Diagnosis for Autoimmune Disease and Dry Eye Syndrome

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04747288

Enrollment

1800

Registered

2021-02-10

Start date

2021-02-01

Completion date

2024-12-31

Last updated

2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTTraditional 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_TESTTraditional Chinese Medicine tongue diagnosis

DIAGNOSTIC_TESTHeart 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_TESTSchirmer'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_TESTOcular 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_TESTEULAR 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_TEST36-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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

Inclusion 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 *

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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).
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).
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).
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).
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).

Countries

Taiwan

Contacts

Primary ContactChang Ching-Mao, M.D., Ph.D.

magicbjp@gmail.com886-28757453 Ext. 333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026