"CuraMed" and "Curamin" in Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390349
• Other study ID #: EP-1001
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: June 21, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: EuroPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Placebo

Dietary Supplement:
• Curamin

• CuraMed

Locations

Country	Name	City	State
Armenia	Erebuni Medical Center	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
EuroPharma, Inc.

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		12 weeks
Primary	Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function		12 weeks