Rosehip Powder for Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430481
• Other study ID #: H-1-2011-018
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2011
• Last updated: August 9, 2016
• Start date: August 2011
• Est. completion date: January 2014

Study information

• Verified date: August 2016
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: 'The Capital Region of Denmark'
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
Frederiksberg University Hospital	Axellus, Oak Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, Walking on flat surface - range: 0-100	Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item	week 12	No
Secondary	Pain - range: 0-100	KOOS	week 12	No
Secondary	Symptoms - range: 0-100	KOOS	week 12	No
Secondary	Function in daily living - range: 0-100	KOOS	week 12	No
Secondary	Knee related Quality of life - range: 0-100	KOOS	week 12	No
Secondary	VAS Pain - 0-100	VAS	week 12	No
Secondary	VAS Disability - 0-100	VAS	week 12	No
Secondary	VAS patient global assessment of disease status - 0-100	VAS	week 12	No
Secondary	VAS physician global assessment of disease status - 0-100	VAS	week 12	No
Secondary	Physical component summary - range: 0-100	Short-Form-36 score	week 12	No
Secondary	Mental component summary - range: 0-100	Short-Form-36 score	week 12	No

External Links

•   The Parker Institute, Copenhagen, Denmark