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

NCT00953979 | Completed Phase 4 DMC

• 1 other identifier: 2008-2
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis; Treatment

Keywords

ankylosing spondylitis; treatment; Sulfasalazine; kunxian capsule

Outcome Measures

Primary Outcomes (1)

• proportion of patients achieving ASAS20 response

  12th week

Secondary Outcomes (1)

• proportion of patients achieving BASDAI20/50/70 response

  12th week

Study Arms (2)

Sulfasalazine

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

The placebo capsule was used to be a comparator of kunxian capsule

Drug: kunxian capsule

Interventions

kunxian capsule DRUG

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

Sulfasalazine; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gu Jieruo: lead
• China-Japan Friendship Hospital: collaborator
• Dongguan People's Hospital: collaborator
• Zhujiang Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (1)

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Publications (1)

• Li Q, Li L, Bi L, Xiao C, Lin Z, Cao S, Liao Z, Gu J. Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial. Trials. 2016 Jul 22;17(1):337. doi: 10.1186/s13063-016-1438-6.

  PMID: 27449221 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

kunxian

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Jieruo Gu, M.D.

  Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: January 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

CN (1)