measuring the efficicy of the combination of green lipped mussel, curcumin and ribus nigrum (supplement Synofit) on quality of life and pain in patients with osteoarthritis of the knee
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
during the first consultation and at 6, 12 and 18 weeks, the pain scores by the
VAS-scale and quality of life by the KOOS-score are taken. Another outcome is
extra pain medication within one of the study periods of suppletion.
Secondary outcome
side-effects
compliance
Background summary
Synofit as supplement is succesfully used in equestrianism for many years (1).
Ingredients of Synofit are the greenlipped mussel, curcumin and ribus nigrem.
Literature describes an inhibited efficacy on inflammation of these
ingredients. Inflammation always excists in osteoarthritis. The suplementation
of Synofit is never described in literature.
In our practice we recommand Synofit beside the standard treatment in patients
with osteoarhtritis of the knee. In our view Synofit is a relief for patients
with an contra-indication for NSAIDs, for example patients using aspirin or
anticoagulants.
Study objective
measuring the efficicy of the combination of green lipped mussel, curcumin and
ribus nigrum (supplement Synofit) on quality of life and pain in patients with
osteoarthritis of the knee
Study design
randomized placebo controlled crossover study
Population
62 patients with osteoarthritis of the knee, seen in a first consultation in
our clinic
Inclusion
- patients with clinical and radiological osteoarthritis of the knee (uni-and
bilateral)
- voluntary participation of patient
Exclusion
- patients with arthritis of the knee with an operative indication
- co-mborbidity: rheumatoid arthritis, polyarthritis
- patient who use medication as: methotrexate and systemic corticosteroids
- arthritis of the hip at the same side (referred pain)
- patients who use analgetica stronger than NSAIDs (f.e. Tramadol, opioids)
- pregnancy
- allergy or sensitivity for ingredients of Synofit
- patient who use Synofit before
complementary investigation
an X-ray of the knee
no further investigation
Intervention
first 6 weeks of placebo or synofit supplemantation after that a wash-out
interval of 6 weeks followed by again 6 weeks of either placebo or synofit
Outcome
during the first consultation and at 6, 12 and 18 weeks, the pain scores by the
VAS-scale and quality of life by the KOOS-score are taken
Intervention
first 6 weeks of placebo or combination of green lipped mussel, curcumin and
ribus nigrum (supplement Synofit) supplemantation after that a wash-out
interval of 6 weeks followed by 6 weeks of either placebo or combination of
green lipped mussel, curcumin and ribus nigrum (supplement Synofit)
Study burden and risks
Participants recieve information about the study and can abstain of
participation at any time during the study.
Patients with an allergy or sensitivity for one of the ingredients of the
combination of green lipped mussel, curcumin and ribus nigrum (supplement
Synofit) will be excluded.
willybrandtlaan 10
Ede 6716 RP
NL
willybrandtlaan 10
Ede 6716 RP
NL
Listed location countries
Age
Inclusion criteria
- patients with clinical and radiological osteoarthritis of the knee (uni-and bilateral)
- voluntary participation
Exclusion criteria
- patients with arthritis of the knee with an operation indication
- comborbidity: rheumatoid arthritis, polyarthritis
- patient who use medication as: methotrexate and systemic corticosteroids
- arthritis of the hip at the same side (referred pain)
- patients who use analgetica stronger than NSAIDs (f.e. Tramadol, Opioids)
- pregnancy
- allergic or sensitivity for ingredients of Synofit
- patient who use Synofit before
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 | NL40936.081.12 |