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Treatment of Sjögren's Syndrome with Traditional Chinese Medicine: A Real-World Prospective Registry-Based Cohort Study

Treatment of Sjögren's Syndrome with Traditional Chinese Medicine: A Real-World Prospective Registry-Based Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001491
Enrollment
Unknown
Registered
2026-06-10
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren's Syndrome

Interventions

Exposed group:TCM alone or TCM combined with Western medicine
Non-exposed group:Western medicine alone

Sponsors

Suzhou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.1 Meet the classification criteria for pSS established by the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) in 2016; 1.2 Aged 18 to 75 years; 1.3 Patients were informed and consented to participate in this study.

Exclusion criteria

Exclusion criteria: 2.1 Complicated with severe liver or kidney disease, cardiovascular or cerebrovascular disease, respiratory system disease, or diabetes with poor glycemic control; 2.2 Complicated with hematologic disease, tumor, or other autoimmune diseases; 2.3 Patients who refused to participate in this study.

Design outcomes

Primary

MeasureTime frame
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI);EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI);

Secondary

MeasureTime frame
TCM Symptom Score Scale / TCM Symptom Scale;Hospital Anxiety and Depression Scale (HADS);Multidimensional Fatigue Inventory (MFI);Ocular Surface Disease Index (OSDI); Oral Health Impact Profile (OHIP);Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F);36-Item Short Form Health Survey (SF-36);Female Sexual Function Index (FSFI);

Countries

China

Contacts

Public ContactHao DongLin

Suzhou Hospital of Traditional Chinese Medicine

haodonglin2006@163.com13771918347

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026