drugset / Trial / NCT00953979
Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis
Phase 4
Completed
126 enrolled
Gu Jieruo
China-Japan Friendship Hospital · collabDongguan People's Hospital · collabHuashan Hospital · collabZhujiang Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2008-01
- Primary completion
- 2009-09
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Kunxian capsule | Traditional medicine (herbal / TCM) | 0.6 g | Oral |