NCT03937271|Withdrawn

Study Stopped

Leak of research funding

Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome

Using the Objective Measurement Methods and TCM Questionnaire to Explore the Association Among TCM Pattern, TCM Tongue Diagnosis and TCM Pulse Diagnosis for Autoimmune Disease and Dry Eye Syndrome

Taipei Veterans General Hospital, Taiwan ClinicalTrials.gov

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1 other identifier

2018-10-003AC

Study Type

observational

Target

N/A

Locations

1 country

Sites

Timeline

RegisteredMay 2019

StartedApr 2019

CompletionDec 2020

Brief Summary

To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse 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

Timeline

Completed

Started Apr 2019

Geographic Reach

1 country

1 active site

Status

withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

April 1, 2019

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed

11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed

28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed

Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

April 22, 2019

Last Update Submit

February 3, 2021

Conditions

Sjögren's Syndrome Systemic Lupus Erythematosus Rheumatoid Arthritis Systemic Sclerosis Ankylosing Spondylitis Dry Eye Syndrome

Keywords

Sjögren's syndromeSystemic lupus erythematosusRheumatoid ArthritisSystemic SclerosisAnkylosing spondylitisDry eye syndrome

Outcome Measures

Primary Outcomes (4)

TCM pattern
TCM pattern is a tool for detecting the constitution among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES).
Five year
TCM tongue diagnosis
TCM tongue diagnosis is a tool for detecting tongue expression among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES).
Five year
TCM pulse diagnosis
TCM pulse diagnosis is a tool for detecting pulse of radial artery among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES) .
Five year
Heart rate variability (HRV)
HRV is a tool for detecting the ratio between High-frequency (HF) activity and low-frequency (LF) activity. among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES) .
Five year

Study Arms (6)

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)

Diagnostic Test: Traditional Chinese Medicine patternDiagnostic Test: Traditional Chinese Medicine tongue diagnosisDiagnostic Test: Traditional Chinese Medicine pulse diagnosisDiagnostic Test: Heart rate variabilityDiagnostic Test: Schirmer's test

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 revised Systemic lupus erythematosus criteria

Rheumatoid Arthritis

Rheumatoid Arthritis 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 2010 ACR/EULAR Rheumatoid Arthritis classification criteria

Systemic Sclerosis

Systemic Sclerosis 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 1980 ACR eSystemic Sclerosis criteria

Ankylosing spondylitis

Ankylosing spondylitis 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 1984 Ankylosing spondylitis Modified New York criteria

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

Interventions

Traditional Chinese Medicine patternDIAGNOSTIC_TEST

Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects will take the Traditional Chinese Medicine pattern.