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

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ClinicalTrials.gov Identifier: NCT03932006
Recruitment Status : Unknown
Verified April 2019 by Gu Jieruo, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Fengshigutong Capsule plus Imrecoxib Drug: Fengshigutong Capsule Drug: Imrecoxib Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
 Drug: Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Experimental: Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
 Drug: Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
Active Comparator: Imrecoxib
Imrecoxib 0.1g twice a day,orally
 Drug: Imrecoxib
Imrecoxib 0.1g twice a day,orally


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. the proportions of patients reaching Assessment in Ankylosing Spondylitis 50% [ Time Frame: 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)

  2. ASAS20 response [ 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)

  3. ASAS5/6 response [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932006


Contacts
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Contact: Jieruo Gu, Prof +8620-85252055 gujieruo@163.com

Locations
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China, Guangdong
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Jieruo Gu, Prof    +8620-85252055    gujieruo@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Jieruo Gu, Prof Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
More Information
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Responsible Party: Gu Jieruo, Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03932006    
Other Study ID Numbers: [2015]2-159
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gu Jieruo, Sun Yat-sen University:
ankylosing spondylitis
Fengshigutong Capsule
imrecoxib
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis