Unveiling the age-related dynamics in Sjögren's syndrome: Insights from heart rate variability and autonomic function.
Hong-Chun Lin, Chien-Ming Yen, Wei-Sheng Chen...
https://pubmed.ncbi.nlm.nih.gov/38454192/Actively Recruiting
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2025-01-17
220
Participants Needed
1
Research Sites
87 weeks
Total Duration
This research aims to understand the pathological mechanisms of Sjogrens Syndrome SJS and Dry Eye Syndrome DES by analyzing the proteins found in exosomes, small particles involved in cell communication. The study focuses on identifying potential diagnostic tools and treatment methods to improve care for people with these conditions. It builds on previous research evaluating herbal tea and acupuncture treatments for dry eye and mouth symptoms in SJS and DES patients. Participants will be divided into groups receiving acupuncture at specific points GB20 or GB20 plus BL2 twice weekly for 8 weeks, or Chinese herbal tea TBDESJS for 8 weeks. Healthy controls will not receive treatment. The study will use various tests and analyses including proteomics, exosome-miRNA, transcriptome, oral microbiota, Schirmers test, tear breakup time, and Traditional Chinese Medicine TCM assessments such as tongue and pulse diagnosis to evaluate treatment effects. During the study, participants will undergo assessments at baseline and after 8 weeks of treatment or observation. These include primary outcome measures like Schirmers test and the Ocular Surface Disease Index OSDI, along with secondary measures such as TCM pattern, cytokine markers, sleep quality indexes, and genetic testing. Researchers will monitor changes in these measures to explore immune regulation and treatment mechanisms, aiming for future clinical application to improve holistic health care for SJS and DES patients.
CONDITIONS
Exosomes Proteomic for Sjogren's Syndrome and Dry Eye Syndrome
C
Ching-Mao Chang, M.D., Ph.D.
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Taipei Veterans General Hospital, Taiwan
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive acupuncture or Chinese herbal tea treatment for dry eye and Sjogren's Syndrome symptoms while undergoing various assessments including proteomic and exosome analyses, Schirmer's test, tear breakup time, and Traditional Chinese Medicine evaluations.
Twice-weekly visits for acupuncture groups; herbal tea participants follow an 8-week treatment schedule with periodic assessments
Duration - Up to several weeks post-treatment
Participants undergo post-treatment evaluations to compare pre- and post-treatment biological and clinical markers, including proteomic, exosome, and other diagnostic tests.
Additional visits for post-treatment assessments depending on cohort assignment
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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Hong-Chun Lin, Chien-Ming Yen, Wei-Sheng Chen...
https://pubmed.ncbi.nlm.nih.gov/38454192/Chien-Ming Yen, Hong-Chun Lin, Wei-Sheng Chen...
https://pubmed.ncbi.nlm.nih.gov/39473287/Taipei Veterans General Hospital, Taiwan
Lead Sponsor