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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 29, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedAugust 10, 2016
August 1, 2016
2.4 years
August 29, 2011
August 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain, Walking on flat surface - range: 0-100
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item
week 12
Secondary Outcomes (10)
Pain - range: 0-100
week 12
Symptoms - range: 0-100
week 12
Function in daily living - range: 0-100
week 12
Knee related Quality of life - range: 0-100
week 12
VAS Pain - 0-100
week 12
- +5 more secondary outcomes
Study Arms (3)
Standard Rosehip Powder (A)
ACTIVE COMPARATOR6 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)
New rosehip formulation (B)
EXPERIMENTAL6 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)
New rosehip formulation in half dose (C)
EXPERIMENTAL3 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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Frederiksberg University Hospitallead
- Axelluscollaborator
- Oak Foundationcollaborator
Study Sites (1)
The Parker Institute, Frederiksberg Hospital
Frederiksberg, 2000, Denmark
Related 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. doi: 10.1002/art.1780290816.
PMID: 3741515BACKGROUNDChristensen 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.
PMID: 18407528BACKGROUNDZhang 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.
PMID: 20170770BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Bliddal, Professor
The Parker Institute, Frederiksberg Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 29, 2011
First Posted
September 8, 2011
Study Start
August 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
August 10, 2016
Record last verified: 2016-08