Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis

This study has been completed.
Sponsor:
Collaborators:
China-Japan Friendship Hospital
Dongguan People's Hospital
Zhanjiang People's Hospital
Huashan Hospital
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00953979
First received: August 5, 2009
Last updated: January 18, 2012
Last verified: January 2012

August 5, 2009
January 18, 2012
January 2008
September 2009   (final data collection date for primary outcome measure)
proportion of patients achieving ASAS20 response [ Time Frame: 12th week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953979 on ClinicalTrials.gov Archive Site
proportion of patients achieving BASDAI20/50/70 response [ Time Frame: 12th week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis
A Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical Trial

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 proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ankylosing Spondylitis
  • Treatment
Drug: kunxian capsule
The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.
  • Active Comparator: Sulfasalazine
    Sulfasalazine is a drug in treatment RA, AS and ulcerative colonitis. In this study, Sulfasalazine is used to act as an active comparator to access the efficacy of kunxian capsule.
    Intervention: Drug: kunxian capsule
  • Placebo Comparator: placebo
    The placebo capsule was used to be a comparator of kunxian capsule
    Intervention: Drug: kunxian capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
December 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00953979
2008-2
Yes
Gu Jieruo, Sun Yat-sen University
Gu Jieruo
  • China-Japan Friendship Hospital
  • Dongguan People's Hospital
  • Zhanjiang People's Hospital
  • Huashan Hospital
Principal Investigator: Jieruo Gu, M.D. Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP