Exosome-miRNA and Transcriptome Profiling of Dry Eye Syndrome and Sjogren's Syndrome
NCT Number: NCT06475027
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dry Eye Syndrome|Sjogren's Syndrome|Xerophthalmia
Interventions: OTHER: TBDESJS|OTHER: Acupuncture
Sponsor: Taipei Veterans General Hospital, Taiwan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: Ching-Mao Chang, Taipei, 112, Taiwan

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. 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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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., 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)., 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., 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, 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., 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), 8 weeks|Tear breakup time (TBUT), Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease., 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), 8 weeks