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| Name | Class |
|---|---|
| Axellus | INDUSTRY |
| Oak Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Rosehip Powder (A) | Active Comparator | 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) |
|
| New rosehip formulation (B) | Experimental | 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) |
|
| New rosehip formulation in half dose (C) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosehip powder | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, Walking on flat surface - range: 0-100 | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain - range: 0-100 | KOOS | week 12 |
| Symptoms - range: 0-100 | KOOS | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henning Bliddal, Professor | The Parker Institute, Frederiksberg Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute, Frederiksberg Hospital | Frederiksberg | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3741515 | Background | 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. | |
| 18407528 |
| Label | URL |
|---|---|
| The Parker Institute, Copenhagen, Denmark | View source |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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 |
| Background |
| 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. |
| 20170770 | Background | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |