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

Primary Purpose

Ankylosing Spondylitis, Treatment

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
kunxian capsule
Sponsored by
Gu Jieruo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, treatment, Sulfasalazine, kunxian capsule

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sulfasalazine

placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

proportion of patients achieving ASAS20 response

Secondary Outcome Measures

proportion of patients achieving BASDAI20/50/70 response

Full Information

First Posted
August 5, 2009
Last Updated
January 18, 2012
Sponsor
Gu Jieruo
Collaborators
China-Japan Friendship Hospital, Dongguan People's Hospital, Zhujiang Hospital, Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00953979
Brief Title
Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gu Jieruo
Collaborators
China-Japan Friendship Hospital, Dongguan People's Hospital, Zhujiang Hospital, Huashan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis, Treatment
Keywords
ankylosing spondylitis, treatment, Sulfasalazine, kunxian capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sulfasalazine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo capsule was used to be a comparator of kunxian capsule
Intervention Type
Drug
Intervention Name(s)
kunxian capsule
Intervention Description
The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.
Primary Outcome Measure Information:
Title
proportion of patients achieving ASAS20 response
Time Frame
12th week
Secondary Outcome Measure Information:
Title
proportion of patients achieving BASDAI20/50/70 response
Time Frame
12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieruo Gu, M.D.
Organizational Affiliation
Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27449221
Citation
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.
Results Reference
derived

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

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