Rosehip Powder for Knee Osteoarthritis
- Conditions
- Osteoarthritis
- Interventions
- Dietary Supplement: Rosehip powder
- Registration Number
- NCT01430481
- Lead Sponsor
- Frederiksberg University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description New rosehip formulation (B) Rosehip powder 6 capsules of modified hip powder of Rosa canina made from the seeds and husks of the fruits from a subtype of R. canina hip powder (i.e., rosehip) Standard Rosehip Powder (A) Rosehip powder 6 capsules of standardized hip powder of Rosa canina made from the seeds and husks of the fruits from a subtype of R. canina hip powder (i.e., rosehip) New rosehip formulation in half dose (C) Rosehip powder 3 capsules of modified hip powder of Rosa canina made from the seeds and husks of the fruits from a subtype of R. canina hip powder (i.e., rosehip)
- Primary Outcome Measures
Name Time Method Pain, Walking on flat surface - range: 0-100 week 12 Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item
- Secondary Outcome Measures
Name Time Method Pain - range: 0-100 week 12 KOOS
Symptoms - range: 0-100 week 12 KOOS
VAS Disability - 0-100 week 12 VAS
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
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
Trial Locations
- Locations (1)
The Parker Institute, Frederiksberg Hospital
🇩🇰Frederiksberg, Denmark