Osteoarthritis
Conditions
Keywords
rosehip, osteoarthritis, pain, knee, RCT
Brief summary
The aim of this study is to compare three combinations of preparations in a comparative trial program on rosehip powder for knee OA. The trial is a comparative, 12-week, randomized, double-blind, active-controlled trial, designed to determine the comparative efficacy and safety of these preparations in patients with pain from knee OA.
Detailed description
Complementary or alternative therapies (incl. nutraceuticals - functional ingredients sold as powders, pills, and other medicinal forms not generally associated with food) for OA are commonly used, and it is therefore important that health care providers are aware of the evidence supporting the claims. One proposed nutraceutical which has shown promising results in OA patients, is the hip powder of Rosa canina. The findings from a previous meta-analysis of rosehip powder from Rosa canina for symptomatic treatment of OA was a small but potentially relevant reduction of pain and a statistically significant reduction in use of analgesics. The present study is undertaken to compare two different products, one of which is tested in two different doses, in a non-inferiority design.
Interventions
DIETARY_SUPPLEMENTRosehip powder
The trial is a patient and physician blinded, 12-week, randomized controlled trial (1:1:1). Participants will be randomized into one of 3 groups: 'Standard rosehip powder' (A), 'New rosehip formulation' (B), or 'New rosehip formulation in half dose' (C). Personnel responsible for data collection will be blinded to group assignment. The patients will report on their symptoms every four weeks.
Sponsors
Axellus
Oak Foundation
Frederiksberg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 40 years of age and have clinical evidence (diagnosed according to the American College of Rheumatology \[ACR\] criteria) and radiographic evidence of OA. * Eligible patients have a self-reported pain level corresponding to at least 40 mm on a 100 mm VAS when screened
Exclusion criteria
* Patients will not be considered eligible if they are considered morbidly obese -having a body mass index (BMI) above 40 kg/m2, concurrent medical or arthritic conditions that could confound evaluation of the index joint, or coexisting disease that could preclude successful completion of the trial. * Patients who already take a rosehip powder as a dietary supplement; have inability to speak Danish fluently; or have a mental state impeding compliance with the program will not be considered eligible for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Walking on flat surface - range: 0-100 | week 12 | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms - range: 0-100 | week 12 | KOOS |
| Function in daily living - range: 0-100 | week 12 | KOOS |
| Knee related Quality of life - range: 0-100 | week 12 | KOOS |
| VAS Pain - 0-100 | week 12 | VAS |
| Pain - range: 0-100 | week 12 | KOOS |
| VAS patient global assessment of disease status - 0-100 | week 12 | VAS |
| VAS physician global assessment of disease status - 0-100 | week 12 | VAS |
| Physical component summary - range: 0-100 | week 12 | Short-Form-36 score |
| Mental component summary - range: 0-100 | week 12 | Short-Form-36 score |
| VAS Disability - 0-100 | week 12 | VAS |
Countries
Denmark
Outcome results
None listed