"CuraMed" and "Curamin" in Osteoarthritis

EuroPharma

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Dietary Supplement: Curamin; Other: Placebo; Dietary Supplement: CuraMed

Study type: Interventional

Funder types: Industry

Identifiers

NCT02390349

EP-1001

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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179 participants in 3 patient groups, including a placebo group

CuraMed (BCM-95)

Experimental group

Description:

67 patients, treatment with CuraMed (BCM-95), one capsule (500 mg) orally, three times daily for 12 weeks

Treatment:

Dietary Supplement: CuraMed

Curamin

Experimental group

Description:

67 patients, treatment with Curamin, one capsule (500 mg) orally, three times daily for 12 weeks

Treatment:

Dietary Supplement: Curamin

Placebo

Placebo Comparator group

Description:

67 patients, treatment with placebo, one capsule (500 mg) orally, three times daily for 12 weeks

Treatment:

Other: Placebo