A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis

Study 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.

Official Title
-----------------
A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Fengshigutong Capsule plus Imrecoxib
* Drug: Fengshigutong Capsule
* Drug: Imrecoxib


Participation Criteria
=================
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 Pregnant and lactating women Alcohol and drug abuse Spinal cord compression

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fengshigutong Capsule plus Imrecoxib<br>Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally | Drug: Fengshigutong Capsule plus Imrecoxib<br>* Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally<br>|
| Experimental: Fengshigutong Capsule<br>Fengshigutong Capsule 1.2g twice a day,orally | Drug: Fengshigutong Capsule<br>* Fengshigutong Capsule 1.2g twice a day,orally<br>|
| Active Comparator: Imrecoxib<br>Imrecoxib 0.1g twice a day,orally | Drug: Imrecoxib<br>* Imrecoxib 0.1g twice a day,orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% | 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) | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 50% | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) | 4 week | 
| ASAS20 response | 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) | 4 week | 
| ASAS5/6 response | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) | 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankylosing spondylitis, Fengshigutong Capsule, imrecoxib