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OpenTrials
Completed

NCT Number: NCT02390349

"CuraMed" and "Curamin" in Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erebuni Medical Center

Yerevan, Armenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Curamin

Dietary Supplement

CuraMed

Dietary Supplement

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

EuroPharma, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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