A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
干预措施: Fengshigutong Capsule plus Imrecoxib (Drug)
Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
干预措施: Fengshigutong Capsule (Drug)
Imrecoxib
Imrecoxib 0.1g twice a day,orally
干预措施: Imrecoxib (Drug)
结局指标
主要结局
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
时间窗: 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)
次要结局
- ASAS5/6 response(4 week)
- the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%(4 week)
- ASAS20 response(4 week)
研究者
Gu Jieruo
Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University