Dry Eye SyndromeNCT06475027
Exosome-miRNA and Transcriptome Profiling of Dry Eye Syndrome and Sjogren's Syndrome
An observational study of Dry Eye Syndrome and Sjogren's Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study combines data from two trials testing acupuncture (ACUDES) and a Chinese herbal tea bag TBDESJS for Dry Eye Syndrome and Sjögren's syndrome. Both treatments improved tear production. Researchers will now analyze participants' blood remaining samples and other data to understand how these therapies work. 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, Sjogren's Syndrome, Xerophthalmia
- What is being tested?
- TBDESJS and Acupuncture
- Type of treatment
- Pill or oral medicine
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 1. Dry Eye Syndrome (DES): Participants diagnosed with Dry Eye Syndrome, characterized by symptoms such as ocular discomfort, dryness, and visual disturbances. 2. Sjögren's Syndrome (SS):Patients diagnosed with Sjögren's Syndrome, an autoimmune disorder marked by dry eyes and mouth, often accompanied by systemic manifestations. 3. non AIDDES Healthy Controls (NHC): Healthy individuals without any history of dry eye symptoms or autoimmune diseases, serving as a control group.
Dry eye syndrome
- Inclusion Criteria: aged between 20 and 75 years Schirmer's test less than 10 mm/5 min
- Exclusion Criteria: Pregnancy With eye inflammation or infectious eye disease Accepted operation of eye
Sjögren's syndrome
- Inclusion Criteria: 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.
- Exclusion Criteria: 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. non AIDDES Healthy Controls
- Inclusion Criteria: aged between 20 and 75 years without any Chronic disease
- Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Systematic Dissection of Exosome-miRNA and Transcriptome Profiling of Dry Eye Syndrome and Sjogren's Syndrome for Alleviating the Sicca Symptoms
This study combines data from two trials testing acupuncture (ACUDES) and a Chinese herbal tea bag TBDESJS for Dry Eye Syndrome and Sjögren's syndrome. Both treatments improved tear production. Researchers will now analyze participants' blood remaining samples and other data to understand how these therapies work. They will use advanced methods to identify tiny RNA molecules and immune system activity. This integrated approach aims to explain how acupuncture and TBDESJS improve dryness and support their use in managing these conditions.
Read the detailed description
Objective: In this study, we aimed to evaluate the therapeutic efficacy and mechanism of acupuncture and Chinese herbal tea bag TBDESJS in patients with Dry Eye Syndrome (DES) and Sjögren's Syndrome (SJS).
Research Background: The ACUDES study, funded by the National Science Council, focuses on assessing the immediate and long-term therapeutic effects of acupuncture at the Fengchi GB20 and Zanzhu BL2 points, combined with a comprehensive analysis of oral microbiota. The TBDESJS study at Taipei Veterans General Hospital investigates the effectiveness of Chinese herbal tea bags TBDESJS in alleviating dryness symptoms in the mouth and eyes of patients with DES and SJS. Progress in the ACUDES and TBDESJS clinical trials indicates significant improvement in clinical efficacy before and after treatment in SJS and DES participants. After 16 weeks of treatment in the TBDESJS study, Schirmer's test showed a significant increase in tear secretion: 7.51-7.63 mm in the left eye (P<0.001) and 7.85-8.66 mm in the right eye (P<0.001). In ACUDES, SJS and DES participants were divided into Fengchi (GB) and Fengchi plus Zanzhu (GBL) groups, with Schirmer's test showing significant increases in tear secretion after 16 weeks of treatment: 6.44-7.51 mm in the left eye (P<0.001) and 6.44-7.51 mm in the right eye (P<0.001).
Methods: In the first year, this study will analyze remaining samples from TBDESJS and ACUDES participants, aiming to extend the analysis to 80 DES and 110 SJS participants, and 30 NHC, and then we identified the 40 DES participants and 60 SJS participants who exhibited the most significant therapeutic improvement pre- and post-treatment, alongside 30 healthy control subjects. The study will systematically analyze exosome-miRNA and transcriptome to investigate the possible mechanisms by which Chinese herbal tea bags and acupuncture alleviate dryness symptoms in the mouth and eyes. In the second year, the study will use machine learning (supervised learning with Random Forest, Support Vector Machine, Neural Networks, unsupervised learning with K-Means Clustering, Principal Component Analysis, Feature Engineering) and multidimensional statistical methods (descriptive statistics, principal component analysis, cluster analysis, multiple regression) to deeply analyze the comprehensive cross-analysis of Whole-genome genotyping, Cytokines, Schirmer's test, Tear breakup time, Traditional Chinese Medicine constitution, OSDI, ESSPRI, PSQI, FIRST, Traditional Chinese Medicine (TCM) pulse diagnosis, TCM tongue diagnosis, heart rate variability measurements, exosome-miRNA, and transcriptome from the earlier TBDESJS and ACUDES cases. This integrated, cross-disciplinary approach is expected to elucidate potential immunomodulatory pathways influenced by TBDESJS and acupuncture GB20 or BL2, thereby providing a foundational basis for their clinical application in managing DES and SJS, and advancing towards our ultimate goal of Holistic Health Care.
Expected Results:
- Analyze exosomes purified from plasma to identify differentially expressed small RNA molecules in SJS, DES, and NHC.
- Investigate the regulatory roles of small RNA molecules on immune cells.
- Explore the differential expression of small RNA molecules in exosomes before and after treatment with TBDESJS and acupuncture with GB20 or BL2 in SJS and DES participants.
- Investigate the potential pharmacological mechanisms of TBDESJS and acupuncture with GB20 or BL2.
- Conditions
- Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia
- Being tested
- TBDESJS, Acupuncture
- Keywords
- Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Acupuncture, Exosome, transcriptome, GB20, BL2
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBDESJSOther
Chinese herbal tea TBDESJS
AcupunctureOther
acupuncture GB20 or GB20 plus BL2
| Study group | Role | What they receive |
|---|---|---|
| Group GB20 | Group GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the exosome-miRNA, transcriptome, 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: Other: Acupuncture | |
| Group GB20 plus BL2 | 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 exosome-miRNA, transcriptome, 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: Other: Acupuncture | |
| non AIDDES Healthy Controls (NHC) | 1. ACUDES: Healthy control group will not received any treatment. And we could use the exosome-miRNA, transcriptome, 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.
2. TBDESJS: Non DES SJS Healthy Controls (NHC) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Other: Acupuncture | |
| Waiting list | 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 exosome-miRNA, transcriptome, 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: Other: Acupuncture | |
| Dry eye syndrome (DES) | Dry eye syndrome (DES) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the exosome-miRNA, transcriptome, Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Other: TBDESJS | |
| Sjögren's syndrome (SJS) | Sjögren's syndrome (SJS) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the exosome-miRNA, transcriptome, Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Other: TBDESJS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's test
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.
Measured: 8 weeks
Ocular Surface Disease Index (OSDI)
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).
Measured: 8 weeks
Secondary outcomes (11)
TCM pattern
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM pattern to differentiate the 9 types of TCM constitutions.
Measured: 8 weeks
TCM tongue diagnosis
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM tongue diagnosis with camera photo to differentiate the TCM tongue feature factors about Tongue body, Tongue Coating, Red spot, Tooth marks, and Ecchymosis. TCM tongue feature factors would present the status of inflammation, blood stasis, heat, dampness with TCM theory.
Measured: 8 weeks
TCM pulse diagnosis
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM pulse diagnosis with blood pressure monitors to differentiate the TCM pulse feature factors about Floating, Deep, Slow, Rapid, Deficient, Excessive, Slippery, Rough, String-like, Soggy, Fine, Weak. TCM tongue feature factors would present the status of inflammation, blood stasis, heat, dampness with TCM theory.
Measured: 8 weeks
TCM heart rate variability
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM heart rate variability.
Measured: 8 weeks
Whole-genome genotyping(TWBv2.0)
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the Whole-genome genotyping (TWBv2.0).
Measured: 8 weeks
Cytokine markers
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the cytokine markers (IL-17, MMP-9, BAFF, BCMA) analysis.
Measured: 8 weeks
Pittsburgh Sleep Quality Index
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Pittsburgh Sleep Quality Index
Measured: 8 weeks
Ford Insomnia Response to Stress Test
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Ford Insomnia Response to Stress Test.
Measured: 8 weeks
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Measured: 8 weeks
Tear breakup time (TBUT)
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease.
Measured: 8 weeks
Exosome-miRNA, transcriptome
exosome-miRNA, transcriptome can be used to assess for Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
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
- NCT06475027
- Sponsor's protocol ID
- 2023-11-004CC
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Randall Harrell C, Djonov V, Volarevic A, Arsenijevic A, Volarevic V. Mesenchymal Stem Cell-Sourced Exosomes as Potentially Novel Remedies for Severe Dry Eye Disease. J Ophthalmol. 2025 Jan 10;2025:5552374. doi: 10.1155/joph/5552374. eCollection 2025.
PubMed 39839752
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Dissection of Exosome-miRNA and Transcriptome Profiling of Dry Eye Syndrome and Sjogren's Syndrome for Alleviating the Sicca Symptoms
- ClinicalTrials.gov ID
- NCT06475027
- Acronym / sponsor ID
- 2023-11-004CC
- Conditions
- Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia
- Keywords
- Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Acupuncture, Exosome, transcriptome, GB20, BL2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2024 (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 combines data from two trials testing acupuncture (ACUDES) and a Chinese herbal tea bag TBDESJS for Dry Eye Syndrome and Sjögren's syndrome. Both treatments improved tear production. Researchers will now analyze participants' blood remaining samples and other data to understand how these therapies work. They will use advanced methods to identify tiny RNA molecules and immune system activity. This integrated approach aims to explain how acupuncture and TBDESJS improve dryness and support their use in managing these conditions.
Detailed description
Objective: In this study, we aimed to evaluate the therapeutic efficacy and mechanism of acupuncture and Chinese herbal tea bag TBDESJS in patients with Dry Eye Syndrome (DES) and Sjögren's Syndrome (SJS).
Research Background: The ACUDES study, funded by the National Science Council, focuses on assessing the immediate and long-term therapeutic effects of acupuncture at the Fengchi GB20 and Zanzhu BL2 points, combined with a comprehensive analysis of oral microbiota. The TBDESJS study at Taipei Veterans General Hospital investigates the effectiveness of Chinese herbal tea bags TBDESJS in alleviating dryness symptoms in the mouth and eyes of patients with DES and SJS. Progress in the ACUDES and TBDESJS clinical trials indicates significant improvement in clinical efficacy before and after treatment in SJS and DES participants. After 16 weeks of treatment in the TBDESJS study, Schirmer's test showed a significant increase in tear secretion: 7.51-7.63 mm in the left eye (P<0.001) and 7.85-8.66 mm in the right eye (P<0.001). In ACUDES, SJS and DES participants were divided into Fengchi (GB) and Fengchi plus Zanzhu (GBL) groups, with Schirmer's test showing significant increases in tear secretion after 16 weeks of treatment: 6.44-7.51 mm in the left eye (P<0.001) and 6.44-7.51 mm in the right eye (P<0.001).
Methods: In the first year, this study will analyze remaining samples from TBDESJS and ACUDES participants, aiming to extend the analysis to 80 DES and 110 SJS participants, and 30 NHC, and then we identified the 40 DES participants and 60 SJS participants who exhibited the most significant therapeutic improvement pre- and post-treatment, alongside 30 healthy control subjects. The study will systematically analyze exosome-miRNA and transcriptome to investigate the possible mechanisms by which Chinese herbal tea bags and acupuncture alleviate dryness symptoms in the mouth and eyes. In the second year, the study will use machine learning (supervised learning with Random Forest, Support Vector Machine, Neural Networks, unsupervised learning with K-Means Clustering, Principal Component Analysis, Feature Engineering) and multidimensional statistical methods (descriptive statistics, principal component analysis, cluster analysis, multiple regression) to deeply analyze the comprehensive cross-analysis of Whole-genome genotyping, Cytokines, Schirmer's test, Tear breakup time, Traditional Chinese Medicine constitution, OSDI, ESSPRI, PSQI, FIRST, Traditional Chinese Medicine (TCM) pulse diagnosis, TCM tongue diagnosis, heart rate variability measurements, exosome-miRNA, and transcriptome from the earlier TBDESJS and ACUDES cases. This integrated, cross-disciplinary approach is expected to elucidate potential immunomodulatory pathways influenced by TBDESJS and acupuncture GB20 or BL2, thereby providing a foundational basis for their clinical application in managing DES and SJS, and advancing towards our ultimate goal of Holistic Health Care.
Expected Results:
- Analyze exosomes purified from plasma to identify differentially expressed small RNA molecules in SJS, DES, and NHC.
- Investigate the regulatory roles of small RNA molecules on immune cells.
- Explore the differential expression of small RNA molecules in exosomes before and after treatment with TBDESJS and acupuncture with GB20 or BL2 in SJS and DES participants.
- Investigate the potential pharmacological mechanisms of TBDESJS and acupuncture with GB20 or BL2.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group GB20 | – | Other: AcupunctureGroup GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the exosome-miRNA, transcriptome, 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 | – | Other: AcupunctureGroup GB20 plus BL2 will received acupuncture at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the exosome-miRNA, transcriptome, 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. |
| non AIDDES Healthy Controls (NHC) | – | Other: Acupuncture1. ACUDES: Healthy control group will not received any treatment. And we could use the exosome-miRNA, transcriptome, 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. 2. TBDESJS: Non DES SJS Healthy Controls (NHC) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
| Waiting list | – | Other: AcupunctureGroup 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 exosome-miRNA, transcriptome, 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. |
| Dry eye syndrome (DES) | – | Other: TBDESJSDry eye syndrome (DES) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the exosome-miRNA, transcriptome, Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
| Sjögren's syndrome (SJS) | – | Other: TBDESJSSjögren's syndrome (SJS) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the exosome-miRNA, transcriptome, Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, 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
- Study population
- 1. Dry Eye Syndrome (DES): Participants diagnosed with Dry Eye Syndrome, characterized by symptoms such as ocular discomfort, dryness, and visual disturbances. 2. Sjögren's Syndrome (SS):Patients diagnosed with Sjögren's Syndrome, an autoimmune disorder marked by dry eyes and mouth, often accompanied by systemic manifestations. 3. non AIDDES Healthy Controls (NHC): Healthy individuals without any history of dry eye symptoms or autoimmune diseases, serving as a control group.
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 |
|---|---|---|
| TBDESJSChinese herbal tea TBDESJS | Other | Dry eye syndrome (DES), Sjögren's syndrome (SJS) |
| Acupunctureacupuncture GB20 or GB20 plus BL2 | Other | Group GB20, Group GB20 plus BL2, Waiting list, non AIDDES Healthy Controls (NHC) |
Primary outcome
Schirmer's test
Time frame: 8 weeks
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.
Ocular Surface Disease Index (OSDI)
Time frame: 8 weeks
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).
11 secondary outcomes
TCM pattern
Time frame: 8 weeks
TCM tongue diagnosis
Time frame: 8 weeks
TCM pulse diagnosis
Time frame: 8 weeks
TCM heart rate variability
Time frame: 8 weeks
Whole-genome genotyping(TWBv2.0)
Time frame: 8 weeks
Cytokine markers
Time frame: 8 weeks
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
Ford Insomnia Response to Stress Test
Time frame: 8 weeks
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 8 weeks
Tear breakup time (TBUT)
Time frame: 8 weeks
Exosome-miRNA, transcriptome
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 39839752Randall Harrell C, Djonov V, Volarevic A, Arsenijevic A, Volarevic V. Mesenchymal Stem Cell-Sourced Exosomes as Potentially Novel Remedies for Severe Dry Eye Disease. J Ophthalmol. 2025 Jan 10;2025:5552374. doi: 10.1155/joph/5552374. eCollection 2025.
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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.
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 Dry Eye Syndrome and Sjogren's Syndrome, 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?
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: opening soon, as of the sponsor's last update on 26 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Mao Chang, M.D., Ph.D. (88628757453 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: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06475027, which also lists 1 linked publication.
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 26 Jun 2024.