Osteoarthritis, Knee
Conditions
Brief summary
This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will receive Curamin and one group will receive placebo.
Interventions
OTHERPlacebo
DIETARY_SUPPLEMENTCuramin
DIETARY_SUPPLEMENTCuraMed
Sponsors
EuroPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 12 weeks |
| Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function | 12 weeks |
Countries
Armenia
Outcome results
None listed