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"CuraMed" and "Curamin" in Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390349
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
EuroPharma, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Placebo Dietary Supplement: Curamin Dietary Supplement: CuraMed Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: CuraMed (BCM-95)
67 patients, treatment with CuraMed (BCM-95), one capsule (500 mg) orally, three times daily for 12 weeks
 Dietary Supplement: CuraMed
Experimental: Curamin
67 patients, treatment with Curamin, one capsule (500 mg) orally, three times daily for 12 weeks
 Dietary Supplement: Curamin
Placebo Comparator: Placebo
67 patients, treatment with placebo, one capsule (500 mg) orally, three times daily for 12 weeks
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 12 weeks ]
  2. Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390349


Locations
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Armenia
Erebuni Medical Center
Yerevan, Armenia
Sponsors and Collaborators
EuroPharma, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: EuroPharma, Inc.
ClinicalTrials.gov Identifier: NCT02390349    
Other Study ID Numbers: EP-1001
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases