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Clinical Observational Study on Dynamic Changes of Syndrome Patterns in Primary Sjögren's Syndrome and Acupuncture Treatment for Ocular Symptoms

Clinical Observational Study on Dynamic Changes of Syndrome Patterns in Primary Sjögren's Syndrome and Acupuncture Treatment for Ocular Symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001426
Enrollment
Unknown
Registered
2025-07-16
Start date
2024-05-16
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Primary Sjögrens Syndrome

Interventions

Control group:The control group continued the current drug therapy without acupuncture
Experimental group:In addition to the existing medication regimen patients received acupuncture intervention.

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Aged between 18 and 80 years regardless of gender; (2)Patients meeting the 2002 international classification criteria for pSS; (3)Presenting with dry eye symptoms; (4)Patients who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with secondary Sjögren's syndrome; 2.Patients with severe cardiovascular cerebrovascular hepatic or hematopoietic system diseases; 3.Patients with HIV/AIDS lymphoma sarcoidosis or hepatitis virus infection; 4.Patients complicated with lymphoma diabetes mellitus (with retinopathy) Mikulicz's disease sarcoidosis chronic infectious diseases; patients who had received head and neck radiotherapy; or patients with transplant rejection reactions; 5.Women who are planning pregnancy currently pregnant lactating or within 1 year postpartum; 6.Patients with metal allergy or severe needle phobia; 7.Patients with cognitive impairment or inability to communicate independently; 8.Patients with wrist disorders that preclude acupuncture treatment.

Design outcomes

Primary

MeasureTime frame
VAS score for dry eye symptoms;

Secondary

MeasureTime frame
ESR;IgGA/G/M;Acupuncture onset time and Acupuncture effect duration;Dry eye symptom score;Schirmer I test (SIt) and Non-invasive tear film breakup time (NIBUT);CRP;

Countries

China

Contacts

Public ContactxiaoWang

Longhua Hospital Shanghai University of Traditional Chinese Medicine

754063804@qq.com+86 134 7288 7260

Outcome results

None listed

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