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 suffering from knee osteoarthritis. Secondary, stiffness and performance indices will be…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is observed change in self-reported pain on a Numeric
Rating Scale (NRS pain) after 6 weeks as a result of intervention both for
product and placebo.
Secondary outcome
Secondary, pain after 12 weeks (NRS pain), and other self reported disease
related outcomes after 6 and 12 weeks will be assessed through Knee injury and
Osteoarthritis Outcome Scores (KOOS).
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.
Study objective
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
suffering from knee osteoarthritis. Secondary, stiffness and performance
indices will be assessed.
Study design
The study will be set-up as a randomized, double-blind, placebo controlled
intervention trial.
Intervention
For a period of 12 weeks one group receives a daily capsule containing 300 mg
of eggshell membrane, and the other group daily receives a placebo capsule.
Study burden and risks
Subjects are asked to fill in a short questionnaire prior to enrolment. During
84 days subjects will be asked to take either a placebo or product capsule once
a day, and keep a simple daily diary. On a weekly basis, they will be asked to
list NRS pain (0-10). On days 0, 10, 21, 42, and 84 they will fill-in the KOOS
questionnaire. To our opinion, the burden and risks of participation in this
study for physical or mental wellbeing are negligible.
Edisonlaan 8
Drachten 9207 HD
NL
Edisonlaan 8
Drachten 9207 HD
NL
Listed location countries
Age
Inclusion criteria
Age between 40-75
NRS pain of 3 or more
Diagnosed with osteoarthritis of the knee (confirmed by Health Care Professional)
Exclusion criteria
Daily use of NSAIDs
Use of opiates
Use of supplements aimed to target specifically osteoarthritis and/or rheumatoid arthritis
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 |
|---|---|
| CCMO | NL64636.072.18 |