Status:
COMPLETED
Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis
Lead Sponsor:
Gu Jieruo
Collaborating Sponsors:
China-Japan Friendship Hospital
Dongguan People's Hospital
Conditions:
Ankylosing Spondylitis
Treatment
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is pro...
Eligibility Criteria
Inclusion
- 16 to 65 years old, having signed the informed consent;
- fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- BASDAI score more than 4;
- stop taking DMARDs for at least 4 weeks;
- NSAIDs dosage has been stable for at least 4 weeks;
Exclusion
- Intra-articular injection of cortisone within 3 months.
- History of heart failure, multiple sclerosis, COPD, lymphoma or other tumors;
- Accompanied by fibromyalgia or other rheumatic diseases;
- Female of pregnancy or breast feeding;
- History of mental disease and poor compliance.
- History of drug abuse or alcoholism.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00953979
Start Date
January 1 2008
End Date
December 1 2009
Last Update
January 19 2012
Active Locations (1)
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1
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630