Sjögren's SyndromeNCT04747288
Objective Measurement With TCM Pattern for AIDDES
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 with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjögren's Syndrome, Systemic Lupus Erythematosus, Dry Eye Syndrome
- What is being tested?
- Traditional Chinese Medicine pattern, Traditional Chinese Medicine tongue diagnosis and Heart rate variability
- How many people
- 1,800 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2021to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Autoimmune disease (AID) as Sjögren's syndrome (SJS), 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
- aged between 20 and 75 years
- fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
- aged between 20 and 75 years
- fulfilled the 1982 and 1997 ACR revised Systemic lupus erythematosus criteria
- aged between 20 and 75 years
- Schirmer's test less than 10 mm/5 min
Show all 9Show fewer
- aged between 20 and 75 years
- without any Chronic disease
- Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome.
Who cannot join
- Systemic lupus erythematosus
- Dry eye syndrome
- non AIDDES Healthy Controls
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ching-Mao Chang
Taipei, 112
Chang Ching-Mao, M.D., Ph.D., 88628757453 Ext. 333, magicbjp@gmail.com
About this study
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
To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.
Read the 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:
- 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.
- 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.
- Being tested
- Traditional Chinese Medicine pattern, Traditional Chinese Medicine tongue diagnosis, Heart rate variability, Schirmer's test, Ocular Surface Diseast Index (OSDI)
- Keywords
- Sjögren's syndrome, Systemic Lupus Erythematosus, Dry Eye Syndrome
- Medical subject headings
- Sjogren's Syndrome, Lupus Erythematosus, Systemic, 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) 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 diagnosisDiagnostic test
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 variabilityDiagnostic 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 Heart rate variability.
Schirmer's testDiagnostic 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)Diagnostic 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 Ocular Surface Diseast Index (OSDI).
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)Diagnostic 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 EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).
36-Item Short Form Survey (SF-36)Diagnostic 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 36-Item Short Form Survey (SF-36).
| 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). Exclusion Criteria: NA. Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Diseast Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: 36-Item Short Form Survey (SF-36) | |
| 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 and 1997 revised Systemic lupus erythematosus criteria. Exclusion Criteria: NA. Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Diseast Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: 36-Item Short Form Survey (SF-36) | |
| 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. Exclusion Criteria: NA. Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Heart rate variability; Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Diseast Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: 36-Item Short Form Survey (SF-36) | |
| non AIDDES Healthy Controls | Non AIDDES Healthy Controls were enrolled with 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. Receives: Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis |
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), Dry eye syndrome (DES), and healthy control.
Measured: One year
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.
Measured: One year
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).
Measured: One year
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).
Measured: One year
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).
Measured: One year
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).
Measured: One year
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).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Feb 2021
- Primary completion30 Nov 2022
- Study completion31 Dec 2024 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chang Ching-Mao, M.D., Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747288
- Sponsor's protocol ID
- 2020-12-014BC
- Status last verified
- Dec 2022
- First submitted
- 9 Feb 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04747288
- Acronym / sponsor ID
- 2020-12-014BC
- Keywords
- Sjögren's syndrome, Systemic Lupus Erythematosus, Dry Eye Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Feb 2021 (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 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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sjögren's syndrome | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Diseast Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: 36-Item Short Form Survey (SF-36)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). Exclusion Criteria: NA. |
| Systemic lupus erythematosus | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Diseast Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: 36-Item Short Form Survey (SF-36)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 and 1997 revised Systemic lupus erythematosus criteria. Exclusion Criteria: NA. |
| Dry eye syndrome | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosis, Diagnostic Test: Heart rate variability, Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Diseast Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: 36-Item Short Form Survey (SF-36)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. Exclusion Criteria: NA. |
| non AIDDES Healthy Controls | – | Diagnostic Test: Traditional Chinese Medicine pattern, Diagnostic Test: Traditional Chinese Medicine tongue diagnosisNon AIDDES Healthy Controls were enrolled with 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Autoimmune disease (AID) as Sjögren's syndrome (SJS), 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 (9 listed)
- Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome.
Key exclusion criteria (3 listed)
- Systemic lupus erythematosus
- Dry eye syndrome
- non AIDDES Healthy Controls
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) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis. | Diagnostic test | Dry eye syndrome, Sjögren's syndrome, Systemic lupus erythematosus, non AIDDES Healthy Controls |
| Traditional Chinese Medicine tongue diagnosisAutoimmune 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. | Diagnostic test | Dry eye syndrome, Sjögren's syndrome, Systemic lupus erythematosus, non AIDDES Healthy Controls |
| Heart rate variabilityAutoimmune 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 test | Dry eye syndrome, Sjögren's syndrome, Systemic lupus erythematosus |
| Schirmer's testAutoimmune 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 test | Dry eye syndrome, Sjögren's syndrome, Systemic lupus erythematosus |
| 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). | Diagnostic test | Dry eye syndrome, Sjögren's syndrome, Systemic lupus erythematosus |
| 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). | Diagnostic test | Dry eye syndrome, Sjögren's syndrome, Systemic lupus erythematosus |
| 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). | Diagnostic test | Dry eye syndrome, Sjögren's syndrome, Systemic lupus erythematosus |
Primary outcome
TCM pattern
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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 )
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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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.
Chang Ching-Mao, 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Ching-Mao, M.D., Ph.D. (886-28757453 Ext. 333, magicbjp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM pattern (time frame: One year). The study lists 7 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 13 Dec 2022.