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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00953979
Other study ID # 2008-2
Secondary ID
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


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
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