NCT06771427

Brief Summary

By analyzing the differential proteins in exosomes, this study aims to understand the pathological mechanisms of SJS and DES, identify potential diagnostic and therapeutic methods, and advance the diagnosis and treatment of these diseases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

January 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 8, 2025

Last Update Submit

January 15, 2025

Conditions

Dry Eye Syndrome (DES)Sjogren's SyndromeXerophthalmia

Keywords

Dry eye syndromeSjögren's syndromeXerophthalmiaChinese herbal teaNourishing Yin and Moistening DrynessExosomeGB20BL2proteomics

Outcome Measures

Primary Outcomes (2)

  • Schirmer's test

    Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.

    8 weeks

  • Ocular Surface Disease Index (OSDI)

    Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).

    8 weeks

Secondary Outcomes (12)

  • TCM pattern

    8 weeks

  • TCM tongue diagnosis

    8 weeks

  • TCM pulse diagnosis

    8 weeks

  • TCM heart rate variability

    8 weeks

  • Whole-genome genotyping(TWBv2.0)

    8 weeks

  • +7 more secondary outcomes

Study Arms (6)

Group GB20

Group GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the proteomic, exosome-proteomic, , 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.

Other: acupuncture GB20 or GB20 plus BL2

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 proteomic, exosome-proteomic, 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.

Other: acupuncture GB20 or GB20 plus BL2

non AIDDES Healthy Controls (NHC)

ACUDES: Healthy control group will not received any treatment. And we could use the proteomic, exosome-proteomic, 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. 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.

Other: acupuncture GB20 or GB20 plus BL2Drug: Chinese herbal tea TBDESJS

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 proteomic, exosome-proteomic, 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.

Drug: Chinese herbal tea TBDESJS

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 proteomic, exosome-proteomic, 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.

Drug: Chinese herbal tea 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 proteomic, exosome-proteomic, 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.

Drug: Chinese herbal tea TBDESJS

Interventions

acupuncture GB20 or GB20 plus BL2OTHER

acupuncture at acupoint GB20 or GB20 plus BL2 twice a week 8 weeks for efficacy evaluation.

Group GB20Group GB20 plus BL2non AIDDES Healthy Controls (NHC)
Chinese herbal tea TBDESJSDRUG

Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation.

Dry eye syndrome (DES)Sjögren's syndrome (SJS)Waiting listnon AIDDES Healthy Controls (NHC)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Dry Eye Syndrome (DES): Participants diagnosed with Dry Eye Syndrome, characterized by symptoms such as ocular discomfort, dryness, and visual disturbances. Sjögren's Syndrome (SS):Patients diagnosed with Sjögren's Syndrome, an autoimmune disorder marked by dry eyes and mouth, often accompanied by systemic manifestations. non AIDDES Healthy Controls (NHC): Healthy individuals without any history of dry eye symptoms or autoimmune diseases, serving as a control group.

You may not qualify if:

  • non AIDDES Healthy Controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ching-Mao

Taipei, Taiwan, 886, Taiwan

RECRUITING

Related Publications (2)

  • Lin HC, Yen CM, Chen WS, Hsu CC, Kung YY, Wu JH, Su YT, Chen KF, Chen HY, Lien CM, Wang MJ, Chang CM. Unveiling the age-related dynamics in Sjogren's syndrome: Insights from heart rate variability and autonomic function. Int J Rheum Dis. 2024 Mar;27(3):e15088. doi: 10.1111/1756-185X.15088.

    PMID: 38454192BACKGROUND

  • Yen CM, Lin HC, Chen WS, Hsu CC, Liaw CC, Kung YY, Ma CP, Chen HY, Su YT, Chang CM. Evaluation of traditional Chinese medicine tea bag TBDESJS in patients with Sjogren's syndrome and dry eye syndrome: A phase II pilot study. Int J Rheum Dis. 2024 Nov;27(11):e15398. doi: 10.1111/1756-185X.15398.

    PMID: 39473287BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Dry Eye SyndromesSjogren's SyndromeXerophthalmia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesConjunctival Diseases

Study Officials

  • Ching-Mao Chang, M.D., Ph.D.

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Mao Chang, M.D., Ph.D.

CONTACT

8862285757453magicbjp@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Division of Integrative Medicine, Center for Traditional Medicine

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 13, 2025

Study Start

January 16, 2025

Primary Completion

April 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

TW(1)