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

Gu Jieruo

Status and phase: Completed; Phase 4

Conditions: Treatment; Ankylosing Spondylitis

Treatments: Drug: kunxian capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT00953979

2008-2

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Sulfasalazine

Active Comparator group

Description:

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.

Treatment:

Drug: kunxian capsule

placebo

Placebo Comparator group

Description:

The placebo capsule was used to be a comparator of kunxian capsule

Treatment:

Drug: kunxian capsule