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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Ankylosing Spondylitis
Treatment
 Drug: kunxian capsule
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • proportion of patients achieving ASAS20 response [ Time Frame: 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of patients achieving BASDAI20/50/70 response [ Time Frame: 12th week ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
Placebo Comparator: placebo
The placebo capsule was used to be a comparator of kunxian capsule
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953979

Locations
China, Guangdong
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Gu Jieruo
China-Japan Friendship Hospital
Dongguan People's Hospital
Zhanjiang People's Hospital
Huashan Hospital
Investigators
Principal Investigator: Jieruo Gu, M.D. Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Gu Jieruo, Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00953979     History of Changes
Other Study ID Numbers: 2008-2
Study First Received: August 5, 2009
Last Updated: January 18, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
ankylosing spondylitis
treatment
Sulfasalazine
kunxian capsule

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Sulfasalazine
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Infective Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013