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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ankylosing Spondylitis, Treatment

Intervention / Treatment
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* Drug: kunxian capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sulfasalazine<br>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<br>* The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.<br>|
| Placebo Comparator: placebo<br>The placebo capsule was used to be a comparator of kunxian capsule | Drug: kunxian capsule<br>* The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients achieving ASAS20 response |  | 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients achieving BASDAI20/50/70 response |  | 12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankylosing spondylitis, treatment, Sulfasalazine, kunxian capsule