Dry Eye SyndromeNCT04877483
To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome
A study testing Acupuncture, Oral microbiota and Schirmer's test in people with Dry Eye Syndrome and Xerophthalmia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study wants to use a randomized, single-blind, controlled trial to evaluate the efficacy of receiving acupuncture GB20 or GB20 plus BL2 on alleviating the ocular dryness symptom from dry eye syndrome and Sjögren's syndrome. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome, Xerophthalmia
- What is being tested?
- Acupuncture, Oral microbiota and Schirmer's test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- aged between 20 and 75 years
- Schirmer's test less than 10 mm/5 min
- primary or secondary SS
- aged between 20 and 75 years
- fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
- had no abnormal findings of immune, liver, kidney, or blood function evaluations.
Who cannot join
- Pregnancy
- With eye inflammation or infectious eye disease
- Accepted operation of eye
- Sjögren's syndrome
- a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
- pregnancy or breastfeeding
- steroid pulse therapy within three months prior to the commencement of our study.
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
This study wants to use a randomized, single-blind, controlled trial to evaluate the efficacy of receiving acupuncture GB20 or GB20 plus BL2 on alleviating the ocular dryness symptom from dry eye syndrome and Sjögren's syndrome. One hundred dry eye syndrome subjects are composed of 50 dry eye syndrome subjects and 50 Sjögren's syndrome' dry eye subjects, and all are randomized into 40 Group GB20 and 40 Group GB20 plus BL2 (GBL), and 20 Group Waiting list; while we also include 20 healthy controls. Fifty dry eye syndrome subjects are randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list in first year; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation, and 10 Group Waiting list receive no any acupuncture treatment. And we could use the Whole-genome genotyping, oral microbiota, Schirmer's test, Tear breakup time, Cytokines, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. In second year, another 50 dry eye syndrome subjects are also enrolled and randomized into randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation with above outcome measurements, and 10 Group Waiting list receive no any acupuncture treatment. Meanwhile, we also include 20 healthy controls, and we want to find the difference with the comparison between the dry eye syndrome, Sjögren's syndrome and healthy control in second year. Through the analysis for dry eye syndrome and Sjögren's syndrome, we could find the biomarker to differentiate dry eye syndrome, Sjögren's syndrome and healthy control. In the future, this work could be applied for screening and diagnosis of pre-dry eye syndrome and Sjögren's syndrome, and this integrated TCM with Western Medicine plan could be applied for the goal of holistic health care.
Read the detailed description
Method: This study wants to use a randomized, single-blind, controlled trial to evaluate the efficacy of receiving acupuncture GB20 or GB20 plus BL2 on alleviating the ocular dryness symptom from dry eye syndrome and Sjögren's syndrome. One hundred dry eye syndrome subjects are composed of 50 dry eye syndrome subjects and 50 Sjögren's syndrome' dry eye subjects, and all are randomized into 40 Group GB20 and 40 Group GB20 plus BL2 (GBL), and 20 Group Waiting list; while we also include 20 healthy controls. Fifty dry eye syndrome subjects are randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list in first year; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation, and 10 Group Waiting list receive no any acupuncture treatment. And we could use the Whole-genome genotyping, oral microbiota, Schirmer's test, Tear breakup time, Cytokines, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. In second year, another 50 dry eye syndrome subjects are also enrolled and randomized into randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation with above outcome measurements, and 10 Group Waiting list receive no any acupuncture treatment. Meanwhile, we also include 20 healthy controls, and we want to find the difference with the comparison between the dry eye syndrome, Sjögren's syndrome and healthy control in second year. Through the analysis for dry eye syndrome and Sjögren's syndrome, we could find the biomarker to differentiate dry eye syndrome, Sjögren's syndrome and healthy control. In the future, this work could be applied for screening and diagnosis of pre-dry eye syndrome and Sjögren's syndrome, and this integrated TCM with Western Medicine plan could be applied for the goal of holistic health care.
Expected Results:
- To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, oral microbiota, and Cytokines for dry eye syndrome, Sjögren's syndrome and healthy control.
- Integrated functional multi-omics for dry eye syndrome and healthy control.
- To evaluate the efficacy of GB20 plus BL2 for dry eye syndrome and Sjögren's syndrome.
- To evaluate the efficacy of GB20 for dry eye syndrome and Sjögren's syndrome.
- To evaluate the efficacy of BL2 for dry eye syndrome and Sjögren's syndrome.
Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Acupuncture, GB20, BL2
- Conditions
- Dry Eye Syndrome, Xerophthalmia
- Being tested
- Acupuncture, Oral microbiota, Schirmer's test, Tear breakup time, OSDI(Ocular Surface Disease Index)
- Keywords
- dry eye syndromes, Xerophthalmia, acupuncture, GB20, BL2, Oral microbiota
- Medical subject headings
- Dry Eye Syndromes, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture is a form of treatment that inserting very thin needles through a person's skin at specific points on the body. Group GB20 and Group GB20 plus BL2 will received the acupuncture treatment.
Oral microbiotaDiagnostic test
Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.
Schirmer's testDiagnostic test
Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.
Tear breakup timeDiagnostic test
Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.
OSDI(Ocular Surface Disease Index)Diagnostic test
Group GB20 and Group GB20 plus BL2 will take the OSDI test.
TCM patternDiagnostic test
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.
Traditional Chinese Medicine (TCM) tongue diagnosisDiagnostic test
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.
TCM pulse diagnosisDiagnostic test
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.
TCM heart rate variabilityDiagnostic test
Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)Diagnostic test
Group GB20 and Group GB20 plus BL2 will take the ESSPRI.
Whole-genome genotyping(TWBv2.0)Diagnostic test
Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).
Cytokine markersDiagnostic test
Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.
Blood biochemical analysisDiagnostic test
Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).
complete blood count (CBC)Diagnostic test
Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.
SF-36(36-Item Short Form Survey )Diagnostic test
Group GB20 and Group GB20 plus BL2 will take the SF-36 test.
| Study group | Role | What they receive |
|---|---|---|
| Group GB20 | Experimental | Group GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Procedure: Acupuncture; Diagnostic Test: Oral microbiota; Diagnostic Test: Schirmer's test; Diagnostic Test: Tear breakup time; Diagnostic Test: OSDI(Ocular Surface Disease Index); Diagnostic Test: TCM pattern; Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: TCM pulse diagnosis; Diagnostic Test: TCM heart rate variability; Diagnostic Test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index); Diagnostic Test: Whole-genome genotyping(TWBv2.0); Diagnostic Test: Cytokine markers; Diagnostic Test: Blood biochemical analysis; Diagnostic Test: complete blood count (CBC); Diagnostic Test: SF-36(36-Item Short Form Survey ) |
| Group GB20 plus BL2 | Experimental | Group GB20 plus BL2 will received acupuncture at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Procedure: Acupuncture; Diagnostic Test: Oral microbiota; Diagnostic Test: Schirmer's test; Diagnostic Test: Tear breakup time; Diagnostic Test: OSDI(Ocular Surface Disease Index); Diagnostic Test: TCM pattern; Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: TCM pulse diagnosis; Diagnostic Test: TCM heart rate variability; Diagnostic Test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index); Diagnostic Test: Whole-genome genotyping(TWBv2.0); Diagnostic Test: Cytokine markers; Diagnostic Test: Blood biochemical analysis; Diagnostic Test: complete blood count (CBC); Diagnostic Test: SF-36(36-Item Short Form Survey ) |
| Healthy control | Other | Healthy control group will not received any treatment. And we could use the oral microbiota, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability to find the difference with the comparison between the dry eye syndrome and healthy control. Receives: Diagnostic Test: Oral microbiota; Diagnostic Test: TCM pattern; Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: TCM pulse diagnosis; Diagnostic Test: TCM heart rate variability; Diagnostic Test: Whole-genome genotyping(TWBv2.0); Diagnostic Test: Cytokine markers |
| Waiting list | Other | Group Waiting list will not received any treatment. at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Diagnostic Test: Oral microbiota; Diagnostic Test: Schirmer's test; Diagnostic Test: Tear breakup time; Diagnostic Test: OSDI(Ocular Surface Disease Index); Diagnostic Test: TCM pattern; Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: TCM pulse diagnosis; Diagnostic Test: TCM heart rate variability; Diagnostic Test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index); Diagnostic Test: Whole-genome genotyping(TWBv2.0); Diagnostic Test: Cytokine markers; Diagnostic Test: Blood biochemical analysis; Diagnostic Test: complete blood count (CBC); Diagnostic Test: SF-36(36-Item Short Form Survey ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's test
Schirmer's test is a tool for evaluating aqueous tear production among the dry eye syndrome.
Measured: one year
OSDI(Ocular Surface Disease Index)
OSDI(Ocular Surface Disease Index) is a tool to rate the severity of dry eye disease among the dry eye syndrome.
Measured: one year
Secondary outcomes (12)
TCM pattern
TCM pattern is a tool for detecting the constitution among the 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 Dry eye syndrome (DES) and healthy control.
Measured: one year
Heart rate variability (HRV)
Heart rate variability (HRV) is a tool for detecting ratio betwee n High-frequency (HF) activity and low-frequency (LF) activity among the Dry eye syndrome (DES) and healthy control.
Measured: one year
TCM pulse diagnosis
TCM tongue diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES) and healthy control.
Measured: one year
SF-36(36-Item Short Form Survey )
SF-36 is a tool for evaluating Health-Related Quality of Life among the 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 dry eye syndrome.
Measured: one year
Tear breakup time (TBUT)
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease.
Measured: one year
Whole-genome genotyping(TWBv2.0)
By using the Whole-genome genotyping(TWBv2.0) of the immune-relate gene(RF5,TNIP1 (TNFAIP3),FCGR2B,TNF,LTA,NFKBIA,STAT4,IL-1β,IL-1R,IL-6,IL-6R,IL-8,IL-8R,IL-10,IL-10R,IL-12,IL-12R,IL-17,IL-17R,IL-18,IL-18R,IL-23,IL-23R,IL-27,IL-27R,TGF-β1,IFN-α,IFN-αR,IFN-γ,IFN-γR,TNFRSF4,BLK,CXCR5,CXCL10 to find the difference with the comparison between the dry eye syndrome and healthy control.
Measured: one year
Oral microbiota
By using the Oral microbiota analysis to find the difference with the comparison between the dry eye syndrome and healthy control.
Measured: one year
Blood biochemical analysis
By using the blood biochemical analysis of BUN,Cre,AST,ALT,CRP and ESR to evaluate the liver function and renal function among the Dry eye syndrome.
Measured: one year
Cytokine biomarkers
By using cytokine biomarkers analysis of IL-17,MMP-9,BAFF and BCMA to find the difference with the comparison between the dry eye syndrome and healthy control.
Measured: one year
CBC(complete blood count)
A complete blood count (CBC) is a blood test used to evaluate overall health among the Dry eye syndromes.
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 posted7 May 2021
- Study start6 Dec 2022
- Primary completion31 Dec 2022 (estimated)
- 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 Dry Eye 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 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
- NCT04877483
- Sponsor's protocol ID
- 2020-07-003C
- Status last verified
- Dec 2022
- First submitted
- 4 May 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
- To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT04877483
- Acronym / sponsor ID
- 2020-07-003C
- Conditions
- Dry Eye Syndrome, Xerophthalmia
- Keywords
- dry eye syndromes, Xerophthalmia, acupuncture, GB20, BL2, Oral microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 May 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.
This study wants to use a randomized, single-blind, controlled trial to evaluate the efficacy of receiving acupuncture GB20 or GB20 plus BL2 on alleviating the ocular dryness symptom from dry eye syndrome and Sjögren's syndrome. One hundred dry eye syndrome subjects are composed of 50 dry eye syndrome subjects and 50 Sjögren's syndrome' dry eye subjects, and all are randomized into 40 Group GB20 and 40 Group GB20 plus BL2 (GBL), and 20 Group Waiting list; while we also include 20 healthy controls. Fifty dry eye syndrome subjects are randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list in first year; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation, and 10 Group Waiting list receive no any acupuncture treatment. And we could use the Whole-genome genotyping, oral microbiota, Schirmer's test, Tear breakup time, Cytokines, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. In second year, another 50 dry eye syndrome subjects are also enrolled and randomized into randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation with above outcome measurements, and 10 Group Waiting list receive no any acupuncture treatment. Meanwhile, we also include 20 healthy controls, and we want to find the difference with the comparison between the dry eye syndrome, Sjögren's syndrome and healthy control in second year. Through the analysis for dry eye syndrome and Sjögren's syndrome, we could find the biomarker to differentiate dry eye syndrome, Sjögren's syndrome and healthy control. In the future, this work could be applied for screening and diagnosis of pre-dry eye syndrome and Sjögren's syndrome, and this integrated TCM with Western Medicine plan could be applied for the goal of holistic health care.
Detailed description
Method: This study wants to use a randomized, single-blind, controlled trial to evaluate the efficacy of receiving acupuncture GB20 or GB20 plus BL2 on alleviating the ocular dryness symptom from dry eye syndrome and Sjögren's syndrome. One hundred dry eye syndrome subjects are composed of 50 dry eye syndrome subjects and 50 Sjögren's syndrome' dry eye subjects, and all are randomized into 40 Group GB20 and 40 Group GB20 plus BL2 (GBL), and 20 Group Waiting list; while we also include 20 healthy controls. Fifty dry eye syndrome subjects are randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list in first year; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation, and 10 Group Waiting list receive no any acupuncture treatment. And we could use the Whole-genome genotyping, oral microbiota, Schirmer's test, Tear breakup time, Cytokines, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. In second year, another 50 dry eye syndrome subjects are also enrolled and randomized into randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation with above outcome measurements, and 10 Group Waiting list receive no any acupuncture treatment. Meanwhile, we also include 20 healthy controls, and we want to find the difference with the comparison between the dry eye syndrome, Sjögren's syndrome and healthy control in second year. Through the analysis for dry eye syndrome and Sjögren's syndrome, we could find the biomarker to differentiate dry eye syndrome, Sjögren's syndrome and healthy control. In the future, this work could be applied for screening and diagnosis of pre-dry eye syndrome and Sjögren's syndrome, and this integrated TCM with Western Medicine plan could be applied for the goal of holistic health care.
Expected Results:
- To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, oral microbiota, and Cytokines for dry eye syndrome, Sjögren's syndrome and healthy control.
- Integrated functional multi-omics for dry eye syndrome and healthy control.
- To evaluate the efficacy of GB20 plus BL2 for dry eye syndrome and Sjögren's syndrome.
- To evaluate the efficacy of GB20 for dry eye syndrome and Sjögren's syndrome.
- To evaluate the efficacy of BL2 for dry eye syndrome and Sjögren's syndrome.
Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Acupuncture, GB20, BL2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group GB20 | Experimental | Procedure: Acupuncture, Diagnostic Test: Oral microbiota, Diagnostic Test: Schirmer's test, Diagnostic Test: Tear breakup time, Diagnostic Test: OSDI(Ocular Surface Disease Index), Diagnostic Test: TCM pattern, Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: TCM pulse diagnosis, Diagnostic Test: TCM heart rate variability, Diagnostic Test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index), Diagnostic Test: Whole-genome genotyping(TWBv2.0), Diagnostic Test: Cytokine markers, Diagnostic Test: Blood biochemical analysis, Diagnostic Test: complete blood count (CBC), Diagnostic Test: SF-36(36-Item Short Form Survey )Group GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
| Group GB20 plus BL2 | Experimental | Procedure: Acupuncture, Diagnostic Test: Oral microbiota, Diagnostic Test: Schirmer's test, Diagnostic Test: Tear breakup time, Diagnostic Test: OSDI(Ocular Surface Disease Index), Diagnostic Test: TCM pattern, Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: TCM pulse diagnosis, Diagnostic Test: TCM heart rate variability, Diagnostic Test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index), Diagnostic Test: Whole-genome genotyping(TWBv2.0), Diagnostic Test: Cytokine markers, Diagnostic Test: Blood biochemical analysis, Diagnostic Test: complete blood count (CBC), Diagnostic Test: SF-36(36-Item Short Form Survey )Group GB20 plus BL2 will received acupuncture at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
| Healthy control | Other | Diagnostic Test: Oral microbiota, Diagnostic Test: TCM pattern, Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: TCM pulse diagnosis, Diagnostic Test: TCM heart rate variability, Diagnostic Test: Whole-genome genotyping(TWBv2.0), Diagnostic Test: Cytokine markersHealthy control group will not received any treatment. And we could use the oral microbiota, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability to find the difference with the comparison between the dry eye syndrome and healthy control. |
| Waiting list | Other | Diagnostic Test: Oral microbiota, Diagnostic Test: Schirmer's test, Diagnostic Test: Tear breakup time, Diagnostic Test: OSDI(Ocular Surface Disease Index), Diagnostic Test: TCM pattern, Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: TCM pulse diagnosis, Diagnostic Test: TCM heart rate variability, Diagnostic Test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index), Diagnostic Test: Whole-genome genotyping(TWBv2.0), Diagnostic Test: Cytokine markers, Diagnostic Test: Blood biochemical analysis, Diagnostic Test: complete blood count (CBC), Diagnostic Test: SF-36(36-Item Short Form Survey )Group Waiting list will not received any treatment. at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (7 listed)
- Sjögren's syndrome
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 |
|---|---|---|
| AcupunctureAcupuncture is a form of treatment that inserting very thin needles through a person's skin at specific points on the body. Group GB20 and Group GB20 plus BL2 will received the acupuncture treatment. | Procedure or surgery | Group GB20, Group GB20 plus BL2 |
| Oral microbiotaGroup GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis. | Diagnostic test | Group GB20, Group GB20 plus BL2, Healthy control, Waiting list |
| Schirmer's testGroup GB20 and Group GB20 plus BL2 will take the Schirmer's test. | Diagnostic test | Group GB20, Group GB20 plus BL2, Waiting list |
| Tear breakup timeGroup GB20 and Group GB20 plus BL2 will take the tear breakup time test. | Diagnostic test | Group GB20, Group GB20 plus BL2, Waiting list |
| OSDI(Ocular Surface Disease Index)Group GB20 and Group GB20 plus BL2 will take the OSDI test. | Diagnostic test | Group GB20, Group GB20 plus BL2, Waiting list |
| TCM patternGroup GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis. | Diagnostic test | Group GB20, Group GB20 plus BL2, Healthy control, Waiting list |
| Traditional Chinese Medicine (TCM) tongue diagnosisGroup GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis. | Diagnostic test | Group GB20, Group GB20 plus BL2, Healthy control, Waiting list |
| TCM pulse diagnosisGroup GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis. | Diagnostic test | Group GB20, Group GB20 plus BL2, Healthy control, Waiting list |
| TCM heart rate variabilityGroup GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability. | Diagnostic test | Group GB20, Group GB20 plus BL2, Healthy control, Waiting list |
| ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)Group GB20 and Group GB20 plus BL2 will take the ESSPRI. | Diagnostic test | Group GB20, Group GB20 plus BL2, Waiting list |
| Whole-genome genotyping(TWBv2.0)Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0). | Diagnostic test | Group GB20, Group GB20 plus BL2, Healthy control, Waiting list |
| Cytokine markersGroup GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis. | Diagnostic test | Group GB20, Group GB20 plus BL2, Healthy control, Waiting list |
| Blood biochemical analysisGroup GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP). | Diagnostic test | Group GB20, Group GB20 plus BL2, Waiting list |
| complete blood count (CBC)Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis. | Diagnostic test | Group GB20, Group GB20 plus BL2, Waiting list |
| SF-36(36-Item Short Form Survey )Group GB20 and Group GB20 plus BL2 will take the SF-36 test. | Diagnostic test | Group GB20, Group GB20 plus BL2, Waiting list |
Primary outcome
Schirmer's test
Time frame: one year
Schirmer's test is a tool for evaluating aqueous tear production among the dry eye syndrome.
OSDI(Ocular Surface Disease Index)
Time frame: one year
OSDI(Ocular Surface Disease Index) is a tool to rate the severity of dry eye disease among the dry eye syndrome.
12 secondary outcomes
TCM pattern
Time frame: one year
TCM tongue diagnosis
Time frame: one year
Heart rate variability (HRV)
Time frame: one year
TCM pulse diagnosis
Time frame: one year
SF-36(36-Item Short Form Survey )
Time frame: one year
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Time frame: one year
Tear breakup time (TBUT)
Time frame: one year
Whole-genome genotyping(TWBv2.0)
Time frame: one year
Oral microbiota
Time frame: one year
Blood biochemical analysis
Time frame: one year
Cytokine biomarkers
Time frame: one year
CBC(complete blood count)
Time frame: one year
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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Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
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?
A study testing Acupuncture, Oral microbiota and Schirmer's test in people with Dry Eye Syndrome and Xerophthalmia, 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 6 inclusion and 7 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?
Schirmer's test (time frame: one year). The study lists 2 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.