No registrations found.
ID
Source
Health condition
osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint includes assessment of self-reported pain (0-10) on a Numerical Rating Scale (NRS pain) after 6 weeks
Secondary outcome
Secondary endpoints include assessment of self-reported pain (0-10) on a Numerical Rating Scale (NRS pain) after 12 weeks, as well as self-reported stiffness and function/health through Knee injury and Osteoarthritis Outcome Scores (KOOS) on days 42 and 84.
Background summary
Poor joint health is a significant burden to society. Millions of people suffer from a kind of joint related disorder or disease, most often osteoarthritis. In those cases the cartilage in the joint is affected through inflammation, and/or inadequate balance of cartilage build-up versus degradation. It is hypothesized that chicken eggshell membrane is effective in the regeneration of cartilage and/or immunomodulation (oral tolerance), and as such positively affects pain and stiffness in joints commonly affected in arthritis. The main objective is to demonstrate a significant improvement in self-reported pain after 6 weeks of consumption of eggshell membrane in a typical population. Secondary, stiffness and performance indices will be assessed. The study will be set-up as a randomized, double-blind, placebo controlled intervention trial. One-hundred and fifty (150) volunteers, men and women, 40-75 years old diagnosed who meet all of the inclusion criteria and none of the exclusion criteria will be included in the study. For a period of 12 weeks one group receives a daily capsule containing eggshell membrane, and the other group daily receives a placebo capsule.
Study objective
It is hypothesized that chicken eggshell membrane is effective in the regeneration of cartilage and/or immunomodulation (oral tolerance), and as such positively affects pain and stiffness in joints commonly affected in arthritis
Study design
0,3,6,12 weeks
Intervention
For a period of 12 weeks one group receives a daily capsule containing eggshell membrane, and the other group daily receives a placebo capsule.
Inclusion criteria
• Age between 40-75
• NRS pain of 3 or more
• Diagnosed with osteoarthritis of the knee (confirmed by Health Care Professional)
• Able to understand, read, and write Dutch
• Daily access to e-mail and internet
• Non-smoking
• Signed informed consent
• Willing to comply with study procedures
Exclusion criteria
• NRS pain of 9 or 10
• Use of supplements aimed to target specifically osteoarthritis and/or rheumatoid arthritis (including glucosamine, chondroitin, collagen, MSM, green lip mussel, Boswelia extract or the-like) within 2 months prior to the start of the study
• Known allergy to eggs or egg products
• Pregnant or breastfeeding women
• Previously enrolment in a study to evaluate pain relief within the past 6 months or currently involved in any other research study involving an investigational product (drug, device, or biologic) or a new application of an approved product
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7309 |
| NTR-old | NTR7525 |
| Other | METC (IRBN, Nijmegen) : ABR 64636 |