Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

Sun Yat-sen University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Early Ankylosing Spondylitis

Interventions

TripterygiumDRUG

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

SulfasalazineDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

ASAS20

Time frame: 12th week

Secondary Outcomes

BASDAI20/50/70

Time frame: 12th week

Data from ClinicalTrials.gov

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