Rosehip Powder for Knee Osteoarthritis

Comparing Different Preparations and Dosages of Rosehip Powder in Patients With Painful Osteoarthritis of the Knee: An Exploratory Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: Rosehip powder

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • The Parker Institute, Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Walking on flat surface - range: 0-100	Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain - range: 0-100	KOOS	week 12
Symptoms - range: 0-100	KOOS	week 12
Function in daily living - range: 0-100	KOOS	week 12
Knee related Quality of life - range: 0-100	KOOS	week 12
VAS Pain - 0-100	VAS	week 12
VAS Disability - 0-100	VAS	week 12
VAS patient global assessment of disease status - 0-100	VAS	week 12
VAS physician global assessment of disease status - 0-100	VAS	week 12
Physical component summary - range: 0-100	Short-Form-36 score	week 12
Mental component summary - range: 0-100	Short-Form-36 score	week 12

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Collaborators: Oak Foundation; Axellus
• Investigators: Principal Investigator: Henning Bliddal, Professor, The Parker Institute, Frederiksberg Hospital, Denmark

Publications and helpful links

General 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. doi: 10.1002/art.1780290816.
• 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.
• 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.

Helpful Links

• The Parker Institute, Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 29, 2011
• First Submitted That Met QC Criteria: September 7, 2011
• First Posted (Estimate): September 8, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: osteoarthritis; pain; knee; RCT; rosehip
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: H-1-2011-018