Back to results"CuraMed" and "Curamin" in Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
Placebo
Curamin
CuraMed
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- Erebuni Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CuraMed (BCM-95)
Curamin
Placebo
Arm Description
67 patients, treatment with CuraMed (BCM-95), one capsule (500 mg) orally, three times daily for 12 weeks
67 patients, treatment with Curamin, one capsule (500 mg) orally, three times daily for 12 weeks
67 patients, treatment with placebo, one capsule (500 mg) orally, three times daily for 12 weeks
Outcomes
Primary Outcome Measures
Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02390349
Brief Title
"CuraMed" and "Curamin" in Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuroPharma, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CuraMed (BCM-95)
Arm Type
Experimental
Arm Description
67 patients, treatment with CuraMed (BCM-95), one capsule (500 mg) orally, three times daily for 12 weeks
Arm Title
Curamin
Arm Type
Experimental
Arm Description
67 patients, treatment with Curamin, one capsule (500 mg) orally, three times daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
67 patients, treatment with placebo, one capsule (500 mg) orally, three times daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Curamin
Intervention Type
Dietary Supplement
Intervention Name(s)
CuraMed
Primary Outcome Measure Information:
Title
Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame
12 weeks
Title
Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Erebuni Medical Center
City
Yerevan
Country
Armenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
29316908
Citation
Haroyan A, Mukuchyan V, Mkrtchyan N, Minasyan N, Gasparyan S, Sargsyan A, Narimanyan M, Hovhannisyan A. Efficacy and safety of curcumin and its combination with boswellic acid in osteoarthritis: a comparative, randomized, double-blind, placebo-controlled study. BMC Complement Altern Med. 2018 Jan 9;18(1):7. doi: 10.1186/s12906-017-2062-z.
Results Reference
derived
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"CuraMed" and "Curamin" in Osteoarthritis
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