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Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

NCT ID: NCT00889694

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Tripterygium

Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.

Intervention Type DRUG

Sulfasalazine

Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.

Intervention Type DRUG

placebo

Placebo: 2 capsules per time, 3 times per day for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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

Other Identifiers

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[2008]2-4

Identifier Type: -

Identifier Source: org_study_id