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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747288
• Other study ID #: 2020-12-014BC
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chang Ching-Mao, M.D., Ph.D.
• Phone: 886-28757453 Ext. 333
• Email: magicbjp[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

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.

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

Intervention

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.
• 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.
• 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.
• 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.
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
Taiwan	Ching-Mao Chang	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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