"CuraMed" and "Curamin" in Osteoarthritis

NCT ID: NCT02390349

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CuraMed (BCM-95)

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

Group Type EXPERIMENTAL

CuraMed

Intervention Type DIETARY_SUPPLEMENT

Curamin

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

Group Type EXPERIMENTAL

Curamin

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Intervention Type OTHER

Curamin

Intervention Type DIETARY_SUPPLEMENT

CuraMed

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

EuroPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erebuni Medical Center

Yerevan, , Armenia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Armenia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29316908 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EP-1001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.