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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00953979

Enrollment

126

Registered

2009-08-06

Start date

2008-01-31

Completion date

2009-12-31

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Treatment

Keywords

ankylosing spondylitis, treatment, Sulfasalazine, kunxian capsule

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.

Interventions

DRUGkunxian capsule

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
proportion of patients achieving ASAS20 response	12th week

Secondary

Measure	Time frame
proportion of patients achieving BASDAI20/50/70 response	12th week

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026