Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
Lead Sponsor:
Chung Shan Medical University
Conditions:
Sjögren's Syndrome
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Have association disease about heart, lung, nerve or mental
- Pregnant or breastfeeding women
- Laboratory abnormality:
- Serum creatinine ≥2.0 mg/dl
- Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl
- Neutrophil or lymphocyte\<0.5 x 109/l
Key Trial Info
Start Date :
May 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04111341
Start Date
May 6 2016
End Date
December 31 2017
Last Update
October 1 2019
Active Locations (1)
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1
Chung Shan Medical University Hospital
Taichung, Taiwan, 402