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NCT Number: NCT00953979

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

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Treatment

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

kunxian capsule

Drug

The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.

Primary outcomes

  1. proportion of patients achieving ASAS20 response

    Time frame: 12th week

Secondary outcomes

  1. proportion of patients achieving BASDAI20/50/70 response

    Time frame: 12th week

Sponsors and collaborators

Lead sponsor

Gu Jieruo

Other

Collaborators

  • China-Japan Friendship Hospital
  • Dongguan People's Hospital
  • Huashan Hospital
  • Zhujiang Hospital

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 6, 2009
Registry last updated
Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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