Clinical trial NCT01430481: Rosehip Powder for Knee Osteoarthritis
Official title: Comparing Different Preparations and Dosages of Rosehip Powder in Patients With Painful Osteoarthritis of the Knee: An Exploratory Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: rosehip
osteoarthritis
pain
knee
RCT
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Axellus
name: Oak Foundation
First posted: 2011-09-08
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain, Walking on flat surface - range: 0-100
timeFrame: week 12
Secondary outcomes:
measure: Pain - range: 0-100
timeFrame: week 12
measure: Symptoms - range: 0-100
timeFrame: week 12
measure: Function in daily living - range: 0-100
timeFrame: week 12
measure: Knee related Quality of life - range: 0-100
timeFrame: week 12
measure: VAS Pain - 0-100
timeFrame: week 12
measure: VAS Disability - 0-100
timeFrame: week 12
measure: VAS patient global assessment of disease status - 0-100
timeFrame: week 12
measure: VAS physician global assessment of disease status - 0-100
timeFrame: week 12
measure: Physical component summary - range: 0-100
timeFrame: week 12
measure: Mental component summary - range: 0-100
timeFrame: week 12
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: The Parker Institute, Frederiksberg Hospital, Denmark
name: Henning Bliddal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
citation: Christensen R, Bartels EM, Altman RD, Astrup A, Bliddal H. Does the hip powder of Rosa canina (rosehip) reduce pain in osteoarthritis patients?--a meta-analysis of randomized controlled trials. Osteoarthritis Cartilage. 2008 Sep;16(9):965-72. doi: 10.1016/j.joca.2008.03.001. Epub 2008 Apr 14.
citation: Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.