Sjögren's SyndromeNCT03937271
Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome
An observational study of Sjögren's Syndrome and Systemic Lupus Erythematosus, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sjögren's Syndrome, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- What is being tested?
- Traditional Chinese Medicine pattern, Traditional Chinese Medicine tongue diagnosis and Traditional Chinese Medicine pulse diagnosis
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES) subjects were screened in the ophthalmology outpatient departments, rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital.
Who may be able to join
- (1) aged between 20 and 75 years
- (2) fulfilled the 2002 American-European Consensus Criteria for SS (AECG) Exclusion Criteria: NA
- Systemic lupus erythematosus
- (1) aged between 20 and 75 years
- (2) fulfilled the 1982 ACR revised Systemic lupus erythematosus criteria Exclusion Criteria: NA
- Rheumatoid Arthritis
Show all 17Show fewer
- (1) aged between 20 and 75 years
- (2) fulfilled the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria Exclusion Criteria: NA
- Systemic Sclerosis
- (1) aged between 20 and 75 years
- (2) fulfilled the 1980 ACR eSystemic Sclerosis criteria Exclusion Criteria: NA
- Ankylosing spondylitis
- (1) aged between 20 and 75 years
- (2) fulfilled the 1984 Ankylosing spondylitis Modified New York criteria Exclusion Criteria: NA
- Dry eye syndrome
- (1) aged between 20 and 75 years
- (2) Schirmer's test less than 10 mm/5 min
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome
Read the detailed description
Objective: To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome
Method:
This study wants to establish the objective measurement of 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. And the investigators want to use the objective measurement tools to explore the association of TCM pattern, heart rate variability (HRV), TCM tongue diagnosis and TCM pulse diagnosis among at least 50 each AID group subjects and at least 50 DES subjects.
Expected Results:
- To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each AID groups.
- To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each DES groups.
- To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis among the AID groups and DES group.
Keyword: Autoimmune disease, Dry eye syndrome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis
- Conditions
- Sjögren's Syndrome, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Systemic Sclerosis, Ankylosing Spondylitis, Dry Eye Syndrome
- Being tested
- Traditional Chinese Medicine pattern, Traditional Chinese Medicine tongue diagnosis, Traditional Chinese Medicine pulse diagnosis, Heart rate variability, Schirmer's test
- Keywords
- Sjögren's syndrome, Systemic lupus erythematosus, Rheumatoid Arthritis, Systemic Sclerosis, Ankylosing spondylitis, Dry eye syndrome
- Medical subject headings
- Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Scleroderma, Systemic, Spondylitis, Ankylosing, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Traditional Chinese Medicine tongue diagnosisDiagnostic 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 tongue diagnosis.
Traditional Chinese Medicine pulse diagnosisDiagnostic 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 pulse diagnosis.
Heart rate variabilityDiagnostic 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 Heart rate variability.
Schirmer's testDiagnostic 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 Schirmer's test.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Heart rate variability; Diagnostic 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 Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test | |
| 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 Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test | |
| 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 Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test | |
| 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 Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test | |
| 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 Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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) .
Measured: 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) .
Measured: Five year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Apr 2019
- Primary completion31 May 2019
- Study completion31 Dec 2020
Why it stopped: Leak of research funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ching-Mao Chang, M.D., Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937271
- Sponsor's protocol ID
- 2018-10-003AC
- Status last verified
- Feb 2021
- First submitted
- 22 Apr 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03937271
- Acronym / sponsor ID
- 2018-10-003AC
- Conditions
- Sjögren's Syndrome, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Systemic Sclerosis, Ankylosing Spondylitis, Dry Eye Syndrome
- Keywords
- Sjögren's syndrome, Systemic lupus erythematosus, Rheumatoid Arthritis, Systemic Sclerosis, Ankylosing spondylitis, Dry eye syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Leak of research funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome
Detailed description
Objective: To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome
Method:
This study wants to establish the objective measurement of 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. And the investigators want to use the objective measurement tools to explore the association of TCM pattern, heart rate variability (HRV), TCM tongue diagnosis and TCM pulse diagnosis among at least 50 each AID group subjects and at least 50 DES subjects.
Expected Results:
- To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each AID groups.
- To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each DES groups.
- To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis among the AID groups and DES group.
Keyword: Autoimmune disease, Dry eye syndrome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sjögren's syndrome | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine pulse diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's testSjögren'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) |
| Systemic lupus erythematosus | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine pulse diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's testSystemic 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 | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine pulse diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's testRheumatoid 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 | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine pulse diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's testSystemic 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 | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine pulse diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's testAnkylosing 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 | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine pulse diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's testDry 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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS), and Dry eye syndrome (DES) subjects were screened in the ophthalmology outpatient departments, rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital.
Key inclusion criteria (17 listed)
- (1) aged between 20 and 75 years
- (2) fulfilled the 2002 American-European Consensus Criteria for SS (AECG) Exclusion Criteria: NA
- Systemic lupus erythematosus
- (1) aged between 20 and 75 years
- (2) fulfilled the 1982 ACR revised Systemic lupus erythematosus criteria Exclusion Criteria: NA
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine patternAutoimmune 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. | Diagnostic test | Ankylosing spondylitis, Dry eye syndrome, Rheumatoid Arthritis, Sjögren's syndrome, Systemic Sclerosis, Systemic lupus erythematosus |
| Traditional Chinese Medicine tongue diagnosisAutoimmune 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 tongue diagnosis. | Diagnostic test | Ankylosing spondylitis, Dry eye syndrome, Rheumatoid Arthritis, Sjögren's syndrome, Systemic Sclerosis, Systemic lupus erythematosus |
| Traditional Chinese Medicine pulse diagnosisAutoimmune 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 pulse diagnosis. | Diagnostic test | Ankylosing spondylitis, Dry eye syndrome, Rheumatoid Arthritis, Sjögren's syndrome, Systemic Sclerosis, Systemic lupus erythematosus |
| Heart rate variabilityAutoimmune 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 Heart rate variability. | Diagnostic test | Ankylosing spondylitis, Dry eye syndrome, Rheumatoid Arthritis, Sjögren's syndrome, Systemic Sclerosis, Systemic lupus erythematosus |
| Schirmer's testAutoimmune 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 Schirmer's test. | Diagnostic test | Ankylosing spondylitis, Dry eye syndrome, Rheumatoid Arthritis, Sjögren's syndrome, Systemic Sclerosis, Systemic lupus erythematosus |
Primary outcome
TCM pattern
Time frame: Five year
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).
TCM tongue diagnosis
Time frame: Five year
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).
TCM pulse diagnosis
Time frame: Five year
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) .
Heart rate variability (HRV)
Time frame: Five year
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) .
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Mao Chang, M.D., Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren's Syndrome and Systemic Lupus Erythematosus, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM pattern (time frame: Five year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.