Objective Measurement With TCM Pattern for AIDDES

Systemic Lupus Erythematosus Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Lupus Erythematosus, Systemic
• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome
• Systemic Lupus Erythematosus

• NCT number: NCT04747288
• Study type: Observational
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chang Ching-Mao, M.D., Ph.D.
• Phone: 886-28757453 Ext. 333
• Email: magicbjp@gmail.com
• Status: Recruiting
• Start date: February 1, 2021
• Completion date: December 31, 2024