Primary Sjögren Syndrome
Conditions
Keywords
randomized controlled trial
Brief summary
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
DRUGYi 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.
DRUGHydroxychloroquine Sulfate
Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.
Sponsors
Qingwen Tao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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 injury.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UWS score | 12 weeks after treatment | unstimulated flow rate of saliva score. it is positive if the UWS ≤1.5 ml/15 min（or 0.1 ml/min). Higher scores(ml/min) mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS score | 12 weeks after treatment | the glandular damage Visual Analog Scale score(dryness, fatigue and pain in the limbs). Patient self-assessed VAS scores ranged from 0 to 10. Higher scores mean a worse outcome. |
| ESSPRI | 12 weeks after treatment | the European Sjögren's Syndrome Patient Reported Index, average of dryness, fatigue and pain in the limbs VAS scores. ESSPRI score varies from 0 to 10. Higher scores mean a worse outcome. |
| Schirmer test | 12 weeks after treatment | Lacrimal secretion test. it is positive if the UWS ≤5 mm/5 min（or 1 mm/min). Higher scores(mm/min) mean a better outcome. |
Countries
China
Outcome results
None listed