Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS) patients.

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

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborators: Chang Gung University; China Medical University Hospital; China Medical University, China; National Science Council, Taiwan

Criteria

Inclusion Criteria:

• Primary or Secondary Sjögren's syndrome patient

• Age from 20 to 75 year old, male or female patient

• Fit the criteria of 2002 year American-European classification

• If the subject took Cyclosporine, Cevimeline, Pilocarpine, Rituximab or other biological agent before enter into our study, the subject need to stop these drugs for one month

• If the subject took Gan-Lu-Yin, Sang- Ju-Yin or Xuefu-Zhuyu-Decoction before enter into our study, the subject need to stop these drugs for one month

• Secondary Sjögren's syndrome patient:

• Stable treatment: Steroid (≦10mg/d) and fixed hydroxychloroquine dose before 3 months enrolled

• No abnormal change of immunology, liver, kidney, and blood function

• No major life threatened condition

Exclusion Criteria:

• Alcohol abuse, DM (Glucose PC>200mg/dL) and major life threatened condition

• Pregnancy or breast feeding

• Abnormal liver and kidney function

• Forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the Chinese herbal medicine except SS-1