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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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19 February 2015 |
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Main ID: |
NCT02173587 |
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Date of registration:
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22/06/2014 |
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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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Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis
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Scientific title:
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Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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56 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02173587 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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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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Duo Li, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Food Science and Nutrition, Zhejiang University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- According to the American College of Rheumatology criteria, patients from Zhejiang
province with active RA were included in this study and all participants were
Chinese. Patients had at least 3 swollen joints and 6 tender joints or had an
erythrocyte sedimentation rate (ESR) of >28mm/hr or morning stiffness of at least 45
min were classified as with active disease.
Exclusion Criteria:
- Subjects suffering hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular
diseases, gastrointestinal problems, liver and renal failure.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Dietary Supplement: Corn oil capsules
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Dietary Supplement: Mussel oil capsules
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Primary Outcome(s)
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Disease activity score that include 28 joint counts and ESR (DAS28)
[Time Frame: Six months (3-month intervals)]
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Secondary ID(s)
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NNSFC81273064
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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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