Rosehip Powder for Knee Osteoarthritis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Dietary Supplement: Rosehip powder	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparing Different Preparations and Dosages of Rosehip Powder in Patients With Painful Osteoarthritis of the Knee: An Exploratory Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:

Pain, Walking on flat surface - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item

Secondary Outcome Measures:

Pain - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
KOOS
Symptoms - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
KOOS
Function in daily living - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
KOOS
Knee related Quality of life - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
KOOS
VAS Pain - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
VAS
VAS Disability - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
VAS
VAS patient global assessment of disease status - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
VAS
VAS physician global assessment of disease status - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
VAS
Physical component summary - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Short-Form-36 score
Mental component summary - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Short-Form-36 score

Estimated Enrollment:	150
Study Start Date:	August 2011
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard Rosehip Powder (A) 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)	Dietary Supplement: Rosehip 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. Other Names: Rosehip Litomove Litozin HybenVital
Experimental: New rosehip formulation (B) 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)	Dietary Supplement: Rosehip 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. Other Names: Rosehip Litomove Litozin HybenVital
Experimental: New rosehip formulation in half dose (C) 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)	Dietary Supplement: Rosehip 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. Other Names: Rosehip Litomove Litozin HybenVital

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430481

Contacts

Contact: Henning Bliddal, Professor	+45 38164158	hb@frh.regionh.dk
Contact: Robin Christensen, MSc, PhD	+45 38164158	Robin.christensen@frh.regionh.dk

Locations

Denmark
The Parker Institute, Frederiksberg Hospital	Recruiting
Frederiksberg, Denmark, 2000
Contact: Line Rustad, Project assistant +45 38164158 line.rustad@frh.regionh.dk
Contact: Claus Bomhoff, Res.Manager +45 38164158 cb@frh.regionh.dk
Sub-Investigator: Robin Christensen, MSc, PhD

Sponsors and Collaborators

Frederiksberg University Hospital

Axellus A/S, Ishøj, Denmark

Oak Foundation, Geneva

Investigators

Principal Investigator:

Henning Bliddal, Professor

The Parker Institute, Frederiksberg Hospital, Denmark

More Information

Publications:

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.

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. Epub 2008 Apr 14. Review.

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. Epub 2010 Feb 11. Review.

Responsible Party:	Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:	NCT01430481 History of Changes
Other Study ID Numbers:	H-1-2011-018
Study First Received:	August 29, 2011
Last Updated:	September 7, 2011
Health Authority:	Denmark: 'The Capital Region of Denmark'

Keywords provided by Frederiksberg University Hospital:

rosehip
osteoarthritis
pain
knee
RCT

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013