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Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Sun Yat-sen University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889694
First Posted: April 29, 2009
Last Update Posted: April 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sun Yat-sen University
April 27, 2009
April 29, 2009
April 29, 2009
October 2008
July 2009   (Final data collection date for primary outcome measure)
ASAS20 [ Time Frame: 12th week ]
Same as current
No Changes Posted
BASDAI20/50/70 [ Time Frame: 12th week ]
Same as current
Not Provided
Not Provided
 
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial
This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Early Ankylosing Spondylitis
  • Drug: Tripterygium
    Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.
  • Drug: Sulfasalazine
    Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.
  • Drug: placebo
    Placebo: 2 capsules per time, 3 times per day for 12 weeks.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
August 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.
  2. Disease is in active status defined by BASDAI>=40mm.
  3. DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.

Exclusion Criteria:

  1. Intra-articular injection of glucocorticoid within 3 months.
  2. Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
  3. Accompanied by fibromyalgia syndrome or other rheumatic diseases.
  4. Female of pregnancy or breast-feeding.
  5. Poor compliance or with mental diseases.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00889694
[2008]2-4
Yes
Not Provided
Not Provided
Jieruo Gu, Rheumatology Department of Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University
Not Provided
Not Provided
Sun Yat-sen University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP