Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yi Qi Yang Yin Decoction, Hydroxychloroquine Sulfate.
- Who it may be relevant to
- Registry conditions: Primary Sjögren Syndrome. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for Primary Sjogren's Syndrome Glandular Damage
Overview
ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.
Interventions
- Drug Yi Qi Yang Yin Decoction
The Yi Qi Yang Yin Decoction (Dihuang 15g, Baihe 12g, Nanshashen 15g, celery Qinghao 10g, Malt 10g, Shengma 6g, Chaihu 6g) prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks. - Drug Hydroxychloroquine Sulfate
Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.
Primary outcome measures
- UWS score [Time frame: 12 weeks after treatment]
Secondary outcome measures (3)
- VAS score [Time frame: 12 weeks after treatment]
- ESSPRI [Time frame: 12 weeks after treatment]
- Schirmer test [Time frame: 12 weeks after treatment]
Eligibility criteria
Inclusion criteria
- 1\. clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.
Exclusion criteria
- 1\. pSS activity system damage (ESSDAI score ≥5); 2. Combined connective tissue diseases other than pSS; 3. Pregnant or lactating women; 4. severe cardiovascular and cerebrovascular diseases, liver and kidney failure, and severe malignant tumors; 5. taking psychotropic drugs; 6. assessed by the investigator to be ineligible for enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan friendship hospital — Beijing
Identifiers
NCT: NCT06519617 · 2024-KY-173