Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475027
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-11
Brief Title:
Exosome-miRNA and Transcriptome Profiling of Dry Eye Syndrome and Sjogrens Syndrome
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Systematic Dissection of Exosome-miRNA and Transcriptome Profiling of Dry Eye Syndrome and Sjogrens Syndrome for Alleviating the Sicca Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study combines data from two trials testing acupuncture ACUDES and a Chinese herbal tea bag TBDESJS for Dry Eye Syndrome and Sjögrens 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 Sjögrens 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 Schirmers test showed a significant increase in tear secretion 751-763 mm in the left eye P0001 and 785-866 mm in the right eye P0001 In ACUDES SJS and DES participants were divided into Fengchi GB and Fengchi plus Zanzhu GBL groups with Schirmers test showing significant increases in tear secretion after 16 weeks of treatment 644-751 mm in the left eye P0001 and 644-751 mm in the right eye P0001
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 Schirmers 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
1 Analyze exosomes purified from plasma to identify differentially expressed small RNA molecules in SJS DES and NHC
2 Investigate the regulatory roles of small RNA molecules on immune cells
3 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
4 Investigate the potential pharmacological mechanisms of TBDESJS and acupuncture with GB20 or BL2
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 Schirmers test showed a significant increase in tear secretion 751-763 mm in the left eye P0001 and 785-866 mm in the right eye P0001 In ACUDES SJS and DES participants were divided into Fengchi GB and Fengchi plus Zanzhu GBL groups with Schirmers test showing significant increases in tear secretion after 16 weeks of treatment 644-751 mm in the left eye P0001 and 644-751 mm in the right eye P0001
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 Schirmers 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
1 Analyze exosomes purified from plasma to identify differentially expressed small RNA molecules in SJS DES and NHC
2 Investigate the regulatory roles of small RNA molecules on immune cells
3 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
4 Investigate the potential pharmacological mechanisms of TBDESJS and acupuncture with GB20 or BL2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None