Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for Primary Sjogren's Syndrome Glandular Damage
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- UWS score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.
排除标准
- •pSS activity system damage (ESSDAI score ≥5);
- •Combined connective tissue diseases other than pSS;
- •Pregnant or lactating women;
- •severe cardiovascular and cerebrovascular diseases, liver and kidney failure, and severe malignant tumors;
- •taking psychotropic drugs;
- •assessed by the investigator to be ineligible for enrollment.
研究组 & 干预措施
conventional program group
Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.
干预措施: Hydroxychloroquine Sulfate (Drug)
optimized program combining Chinese and Western medicine for pSS glandular damage
The herbal prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks.
干预措施: Yi Qi Yang Yin Decoction (Drug)
结局指标
主要结局
UWS score
时间窗: 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.
次要结局
- VAS score(12 weeks after treatment)
- ESSPRI(12 weeks after treatment)
- Schirmer test(12 weeks after treatment)
研究者
Qingwen Tao
chief physician of rheumatism department of Chinese-medicine
China-Japan Friendship Hospital