Actively Recruiting

Age: 20Years - 75Years
All Genders
Healthy Volunteers
ID06771427

Proteomic Analysis of Plasma Exosomes to Study Immune Changes in Sjogren's Syndrome and Dry Eye Syndrome

Led by Taipei Veterans General Hospital, Taiwan · Updated on 2025-01-17

220

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the proteins found in exosomes to better understand the disease processes behind Sjogren's Syndrome (SJS) and Dry Eye Syndrome (DES). The study aims to identify new ways to diagnose and treat these conditions by analyzing differences in protein content. Previous research showed that dry eye symptoms can be severe in SJS patients and that autoimmune diseases may worsen these symptoms. This work builds on earlier studies that tested herbal tea and acupuncture treatments for DES and SJS patients. Participants in this study include people from prior research projects who received either acupuncture at specific points (GB20 and BL2) twice a week for 8 weeks or a Chinese herbal tea (TBDESJS) for 8 weeks. The study will analyze blood samples collected before and after these treatments in 100 participants, including healthy controls. It will also examine a wide range of health measures such as genome data, immune markers, eye tests, questionnaires on symptoms and quality of life, and traditional Chinese medicine assessments. During the study, researchers will perform detailed laboratory tests including Schirmer's test and Ocular Surface Disease Index (OSDI) assessments at 8 weeks to evaluate eye dryness and symptoms. They will track changes in exosome proteins and related immune functions to understand treatment effects. This comprehensive approach aims to discover new diagnostic tools and clarify how the herbal tea and acupuncture may help regulate immunity in patients with SJS and DES.

CONDITIONS

Official Title

Exosomes Proteomic for Sjogren's Syndrome and Dry Eye Syndrome

Who Can Participate

Age: 20Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 20 and 75 years
  • For Dry Eye Syndrome: Schirmer's test less than 10 mm/5 min
  • For Sjogren's Syndrome: primary or secondary diagnosis fulfilling the 2002 American-European Consensus Criteria
  • No abnormal immune, liver, kidney, or blood function evaluations for Sjogren's Syndrome
  • For healthy controls: aged between 20 and 75 years without any chronic disease
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Eye inflammation or infectious eye disease
  • History of eye surgery
  • History of alcohol abuse
  • Diabetes mellitus
  • Major life-threatening conditions
  • Steroid pulse therapy within three months before study start
  • For healthy controls: any diagnosis of Sjogren's Syndrome or Dry Eye Syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ching-Mao

Taipei, Taiwan, Taiwan, 886

Actively Recruiting

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Research Team

C

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

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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Published Research Related To This Trial

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

Evaluation of traditional Chinese medicine tea bag TBDESJS in patients with Sjögren's syndrome and dry eye syndrome: A phase II pilot study.

Chien-Ming Yen, Hong-Chun Lin, Wei-Sheng Chen...

https://pubmed.ncbi.nlm.nih.gov/39473287