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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03932006 |
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Date of registration:
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26/04/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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June 30, 2016 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03932006 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Jieruo Gu, Prof |
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Address:
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Telephone:
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+8620-85252055 |
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Email:
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gujieruo@163.com |
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Affiliation:
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Name:
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Jieruo Gu, Prof |
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Address:
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Telephone:
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+8620-85252055 |
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Email:
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gujieruo@163.com |
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Affiliation:
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Name:
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Jieruo Gu, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Fengshigutong Capsule
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Drug: Imrecoxib
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Drug: Fengshigutong Capsule plus Imrecoxib
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Primary Outcome(s)
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the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
[Time Frame: 4 week]
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Secondary Outcome(s)
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ASAS5/6 response
[Time Frame: 4 week]
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the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%
[Time Frame: 4 week]
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ASAS20 response
[Time Frame: 4 week]
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Secondary ID(s)
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[2015]2-159
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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