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Diagnostic efficacy and blood stasis correlation of parotid/submandibular gland ultrasound in highly suspected Sjogren's syndrome

Correlation between blood stasis factor and salivary gland dysfunction and morphological parameters under ultrasound in primary Sjogren's syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088752
Enrollment
Unknown
Registered
2024-08-26
Start date
2023-03-03
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

primary Sjogren syndrome

Interventions

Gold Standard:Western medical diagnostic criteria: in line with the 2016 ACR/EULAR classification of primary Sjogren's syndrome. Diagnostic criteria of blood stasis in traditional Chinese medicine: ac

Sponsors

Yueyang Hospital of Integrated Chinese and Western medicine, Shanghai University of Traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. All included pSS patients met the pSS classification criteria of ACR/EULAR in 2016; 2. Meet the diagnostic standards of Western medicine and improve relevant examinations; 3. Meet the diagnostic criteria of dryness in TCM; 4. Age =18 years old; 5. Age =75 years.

Exclusion criteria

Exclusion criteria: 1 sSS or patients with other rheumatological diseases, diabetes or local salivary gland diseases; 2 Patients with acute parotitis, salivary gland tumor and other salivary gland lesions; 3. The following diseases that may interfere with clinical diagnosis should be excluded: 1)History of head and neck radiotherapy; 2)Active hepatitis C virus infection (confirmed by PCR); 3)AIDS; 4) sarcoidosis; 5)Amyloidosis;6) Graft-versus-host disease; 7) IGG4-associated diseases. Other cases that affect the salivary gland display and cannot be scored by ultrasound; 4. People with serious lesions or disabilities of vital organs caused by other reasons; 5 Patients with diabetes and malignant tumors; 6 Patients lacking SGUS and LSGB results; 7 Patients with interval of more than 3 months between SGUS and LSGB; 8 Patients who had been treated with hormones or immunosuppressants before;

Design outcomes

Primary

MeasureTime frame
unstimulated salivary flow rate;antiSSA(Ro) antibodies,;minor labial salivary gland biopsy;focus score;OMERACT major salivary gland ultrasonography score;Hypoechoic mass size;blood stasis score;

Secondary

MeasureTime frame
Erythrocyte sedimentation rate;Complement;Immune globulin;Rheumatoid factor;

Countries

China

Contacts

Public ContactXue Luan

Yueyang Hospital of Integrated Chinese and Western medicine, Shanghai University of Traditional Chinese medicine

xelco@163.com+86 189 3056 8151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026