Arthralgia, Stiffness of Unspecified Joint, Not Elsewhere Classified, Disturbance of Activity and Attention, Quality of Life
Conditions
Keywords
Arthralgia, stiffness of joints, quality of life
Brief summary
The aim of this study is to test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.
Detailed description
The included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary. The treatment period is 3 month with the posibility to continue for an additional 3 month.
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo in gelatin capsules
DIETARY_SUPPLEMENTTurmeric
Turmeric in gelatin capsules
Sponsors
Kaj Winther Hansen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Volunteers * 40 years of age or more * Osteoarthritis of the hip and or the knee * Suffering from pain in the hip and or knee -
Exclusion criteria
* If volunteers are on a waiting list for hip or knee surgery * If the volunteers are involved in an other clinical trial * If the volunteers are taking other herbal remedies, which canhav influende on # Osteoarthritis. * Abusers of alcohol and drugs * Volunteers not easy to cope with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADL (Activity of daily living) | 3 month | Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse) |
| Pain | 3 month | Difference in WOMAC pain on a 100 mm VAS scale (high levels worse) |
| Rescue medication | 3 month | Consumption of rescue medication from diaries (mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The volunteer evaluation of Global Disease Severity (PGAD) | 3 month | PGAD is measured on a 100 mm VAS scale (higher values worse) |
| Stiffness of joints | 3 month | Difference in stiffness of joints on a 100 mm VAS scale (higher values worse) |
Other
| Measure | Time frame | Description |
|---|---|---|
| SF-12 (quality of life) | 6 month | Quality of life estimated on a numerical scale (1-3 and 1-6) |
| SF-12 (Quality of life) | 3 month | Quality of life estimated on a numerical scale (1-3 and 1-6) |
Countries
Denmark
Outcome results
None listed