Sjogren's Syndrome Clinical Trial
Official title:
Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome
The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of Primary Sjögren Syndrome.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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