"CuraMed" and "Curamin" in Osteoarthritis
1 other identifier
interventional
179
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 22, 2017
June 1, 2017
1.1 years
March 5, 2015
June 21, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
CuraMed (BCM-95)
EXPERIMENTAL67 patients, treatment with CuraMed (BCM-95), one capsule (500 mg) orally, three times daily for 12 weeks
Curamin
EXPERIMENTAL67 patients, treatment with Curamin, one capsule (500 mg) orally, three times daily for 12 weeks
Placebo
PLACEBO COMPARATOR67 patients, treatment with placebo, one capsule (500 mg) orally, three times daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EuroPharma, Inc.lead
Study Sites (1)
Erebuni Medical Center
Yerevan, Armenia
Related Publications (1)
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.
PMID: 29316908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 17, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
December 1, 2016
Last Updated
June 22, 2017
Record last verified: 2017-06