A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
Overview
- Phase
- Phase 4
- Intervention
- Fengshigutong Capsule plus Imrecoxib
- Conditions
- Ankylosing Spondylitis
- Sponsor
- Sun Yat-sen University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Fengshigutong Capsule in the treatment of active ankylosing spondylitis(AS). The primary purpose is to assess the different maintaining treatment programme in AS patients with controlled inflammation by Imrecoxib. The trial will include 180 patients who will be divided into three group: Fengshigutong Capsule plus Imrecoxib group, Imrecoxib group and Fengshigutong Capsule group. Patients will complete the 4-week therapy.
Investigators
Gu Jieruo
Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •18 to 65 years
- •Meet 1984 modified New York criteria for AS
- •The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
- •NSAIDs washout period of at least 7 days prior to randomization
- •DMARDs washout period of at least 4 weeks prior to randomization
- •Corticosteroids washout period of at least 2 weeks prior to randomization
- •Biological agents washout period of at least 3 months prior to randomization.
Exclusion Criteria
- •Peptic ulcer
- •Unstable cardiac diseases
- •Hematologic disorders
- •Psychosis
- •Malignancy
- •Multiple sclerosis
- •severe COPD
- •fibromyalgia and other rheumatic disease
- •Corticosteroids were injected into the articular cavity within 3 months
- •Chinese medicine was taken within 28 days
Arms & Interventions
Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Intervention: Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
Intervention: Fengshigutong Capsule
Imrecoxib
Imrecoxib 0.1g twice a day,orally
Intervention: Imrecoxib
Outcomes
Primary Outcomes
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
Time Frame: 4 week
ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
Secondary Outcomes
- ASAS5/6 response(4 week)
- the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%(4 week)
- ASAS20 response(4 week)