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

Phase 4

Completed

• Conditions: Ankylosing Spondylitis; Treatment
• Interventions: Drug: kunxian capsule

• Registration Number: NCT00953979
• Lead Sponsor: Gu Jieruo

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulfasalazine	kunxian capsule	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.
placebo	kunxian capsule	The placebo capsule was used to be a comparator of kunxian capsule

Primary Outcome Measures

Name	Time	Method
proportion of patients achieving ASAS20 response	12th week

Secondary Outcome Measures

Name	Time	Method
proportion of patients achieving BASDAI20/50/70 response	12th week

Trial Locations

Locations (1)

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China