A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Have association disease about heart, lung, nerve or mental

• Pregnant or breastfeeding women

• Laboratory abnormality:

  1. Serum creatinine ≥2.0 mg/dl
  2. Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl
  3. Neutrophil or lymphocyte<0.5 x 109/l