NCT00953979

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Gu Jieruo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Ankylosing Spondylitis
• Treatment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2009-08-06
• Last updated: 2012-01-19

Locations

1 site across 1 country: China