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

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chung Shan Medical University

Criteria

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