A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12
研究概览
简要总结
To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.
详细描述
This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 years old
- •Written informed consent obtained
- •Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)
- •The ESSPRI score of the patient of Sjogren's syndrome at least> 3
排除标准
- •Have association disease about heart, lung, nerve or mental
- •Pregnant or breastfeeding women
- •Laboratory abnormality:
- •Serum creatinine ≥2.0 mg/dl
- •Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl
- •Neutrophil or lymphocyte<0.5 x 109/l
研究组 & 干预措施
TCM Gan-Lu-Yin (GLY)
TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks
干预措施: TCM (Gan-Lu-Yin)GLY (Drug)
PLACEBO
TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
干预措施: PLACEBO (Drug)
结局指标
主要结局
Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12
时间窗: week 0, week 12
The investigators use ESSPRI to compared the difference between the week 12 and 0
次要结局
- modified fatigue impact scale (MFI)(week 0, week 4, week 8, week 12)
- Pittsburgh Sleep Quality Index (PSQI)(week 0, week 4, week 8, week 12)
- Body Constitution Questionnaire (BCQ)(week 0, week 4, week 8, week 12)
- Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8(week 0, week 8)
- Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4(week 0, week 4)
- Physicians Global Assessment to measure quality of life (PGA)(week 0, week 4, week 8, week 12)
- Quality of life by SF-36(week 0, week 4, week 8, week 12)
- Visual Analog Scale for pain (VAS)(week 0, week 4, week 8, week 12)
研究者
Cheng-Chung Wei
Professor
Chung Shan Medical University