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Rosehip Powder for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Rosehip powder
Sponsored by
Frederiksberg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring rosehip, osteoarthritis, pain, knee, RCT

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Parker Institute, Frederiksberg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Rosehip Powder (A)

New rosehip formulation (B)

New rosehip formulation in half dose (C)

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Pain, Walking on flat surface - range: 0-100
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2011
Last Updated
August 9, 2016
Sponsor
Frederiksberg University Hospital
Collaborators
Axellus, Oak Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01430481
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Frederiksberg University Hospital
Collaborators
Axellus, Oak Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
rosehip, osteoarthritis, pain, knee, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Rosehip Powder (A)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
New rosehip formulation (B)
Arm Type
Experimental
Arm Description
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)
Arm Title
New rosehip formulation in half dose (C)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Rosehip powder
Other Intervention Name(s)
Rosehip, Litomove, Litozin, HybenVital
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain, Walking on flat surface - range: 0-100
Description
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Pain - range: 0-100
Description
KOOS
Time Frame
week 12
Title
Symptoms - range: 0-100
Description
KOOS
Time Frame
week 12
Title
Function in daily living - range: 0-100
Description
KOOS
Time Frame
week 12
Title
Knee related Quality of life - range: 0-100
Description
KOOS
Time Frame
week 12
Title
VAS Pain - 0-100
Description
VAS
Time Frame
week 12
Title
VAS Disability - 0-100
Description
VAS
Time Frame
week 12
Title
VAS patient global assessment of disease status - 0-100
Description
VAS
Time Frame
week 12
Title
VAS physician global assessment of disease status - 0-100
Description
VAS
Time Frame
week 12
Title
Physical component summary - range: 0-100
Description
Short-Form-36 score
Time Frame
week 12
Title
Mental component summary - range: 0-100
Description
Short-Form-36 score
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Bliddal, Professor
Organizational Affiliation
The Parker Institute, Frederiksberg Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Institute, Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
3741515
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.
Results Reference
background
PubMed Identifier
18407528
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.
Results Reference
background
PubMed Identifier
20170770
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.
Results Reference
background
Links:
URL
http://www.parkerinst.dk
Description
The Parker Institute, Copenhagen, Denmark

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Rosehip Powder for Knee Osteoarthritis

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