Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The proportion of participants who has a 30% or greater reduction in 2 of 3 items,including the numeric analog scale (NAS) of dryness, fatigue, and pain.
研究概览
简要总结
The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of Primary Sjögren Syndrome.
详细描述
This randomized, double-blinded, sham acupuncture controlled trial is aimed to assess the effectiveness and safety of acupuncture in the treatment of Primary Sjögren Syndrome.The eligible participants will be randomly allocated to receive acupuncture or sham acupuncture for 8 weeks.
Assuming a two-sided alpha of 0.05, power of 85%, and a 20% drop-out, a sample sized of 30 would be needed for each group. The statistical analysis will be based on the intention-to-treat principle. Continuous variables will be compared by Student t test or Mann-Whitney U test; categorical variables will be analyzed by chi-square test, Fisher's exact test or Kruskal-Wallis H test as appropriate. For comparison between two time points, paired t-test or Wilcoxon signed rank test will be used as appropriate. A statistically significant difference was set at P<0.05.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To fulfill the American-European Consensus Group Criteria for primary Sjögren syndrome.
- •With the symptoms of primary Sjögren syndrome less than 5 years.
排除标准
- •With an acupuncture contraindication (allergy to metals, skin lesions on relative acupoints, etc.)
- •Taking or taken medicine for primary Sjögren syndrome within last 4 weeks before the enrollment.
结局指标
主要结局
The proportion of participants who has a 30% or greater reduction in 2 of 3 items,including the numeric analog scale (NAS) of dryness, fatigue, and pain.
时间窗: 24 weeks
Subjects will be asked to provide every NAS score based on the average situation over the past 24 hours 13 rather than a point of time. And we will collect NAS scores three times a week in week0-8 (24 times in total) as removal of a variety of factors causing bias, including mental relaxation in weekend, weather changing, or unexpected events life in, etc., each of which may influence the feelings of dryness, fatigue, and pain.
次要结局
- Change in Schirmer test score and unstimulated salivary flow(24 weeks)
- Change in NAS of each item including dryness, fatigue, and pain.(24 weeks)
- Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)(24 weeks)
- Change in Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36)(24 weeks)
- Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels(24 weeks)
- Change in image of Salivary glands measured by ultrasound(24 weeks)
- Change in Hospital Anxiety and Depression (HAD) scale score(24 weeks)
- Adverse events(24 weeks)
研究者
Zhou Xinyao
Attending Physician & Lecturer
Guang'anmen Hospital of China Academy of Chinese Medical Sciences