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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953979
• Other study ID #: 2008-2
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2009
• Last updated: January 18, 2012
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing
• Treatment

Intervention

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

Locations

Country	Name	City	State
China	Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Gu Jieruo	China-Japan Friendship Hospital, Dongguan People's Hospital, Huashan Hospital, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients achieving ASAS20 response		12th week	No
Secondary	proportion of patients achieving BASDAI20/50/70 response		12th week	No