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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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16 December 2017 |
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Main ID: |
NCT02390349 |
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Date of registration:
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05/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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"CuraMed" and "Curamin" in Osteoarthritis
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Scientific title:
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Date of first enrolment:
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April 2015 |
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Target sample size:
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179 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02390349 |
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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: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Armenia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a diagnosis of degenerative hypertrophic osteoarthritis of the knee
(M17, according to International Classification of Diseases (ICD-10) of bone joints,
verified by radiography (Grade 1-3 by Kellgren-Lawrence radiographic grades).
Exclusion Criteria:
- subjects with inflammatory and any secondary arthritis
- moderate and severe synovitis (grades 2 and 3)
- tear of meniscus
- chronic diseases of the kidneys, liver, gastrointestinal, cardiovascular, endocrine
and nervous systems
- allergic anamnesis and drug intolerance
- pregnant or nursing
- history of substance abuse
- subjects taking non-steroidal anti-inflammatory drugs and analgesics within 2 weeks
prior to the study
- subjects taking glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate,
systemic or intra-articular glucocorticoids within three months prior to the study
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Dietary Supplement: Curamin
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Other: Placebo
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Dietary Supplement: CuraMed
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Primary Outcome(s)
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Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function
[Time Frame: 12 weeks]
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Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
[Time Frame: 12 weeks]
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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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