A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Registration Number
- NCT03932006
- Lead Sponsor
- Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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
- Pregnant and lactating women
- Alcohol and drug abuse
- Spinal cord compression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fengshigutong Capsule Fengshigutong Capsule Fengshigutong Capsule 1.2g twice a day,orally Imrecoxib Imrecoxib Imrecoxib 0.1g twice a day,orally Fengshigutong Capsule plus Imrecoxib Fengshigutong Capsule plus Imrecoxib Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
- Primary Outcome Measures
Name Time Method the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% 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 Outcome Measures
Name Time Method ASAS5/6 response 4 week defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
the proportions of patients reaching Assessment in Ankylosing Spondylitis 50% 4 week defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
ASAS20 response 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)
Trial Locations
- Locations (1)
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China