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Rosehip Powder for Knee Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Frederiksberg University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Axellus A/S, Ishøj, Denmark
Oak Foundation, Geneva
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01430481
First received: August 29, 2011
Last updated: September 7, 2011
Last verified: September 2011

August 29, 2011
September 7, 2011
August 2011
April 2012   (final data collection date for primary outcome measure)
Pain, Walking on flat surface - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item
Same as current
Complete list of historical versions of study NCT01430481 on ClinicalTrials.gov Archive Site
  • Pain - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    KOOS
  • Symptoms - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    KOOS
  • Function in daily living - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    KOOS
  • Knee related Quality of life - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    KOOS
  • VAS Pain - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    VAS
  • VAS Disability - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    VAS
  • VAS patient global assessment of disease status - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    VAS
  • VAS physician global assessment of disease status - 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    VAS
  • Physical component summary - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Short-Form-36 score
  • Mental component summary - range: 0-100 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Short-Form-36 score
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
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
  • 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)
    Intervention: Dietary Supplement: Rosehip powder
  • 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)
    Intervention: Dietary Supplement: Rosehip powder
  • 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)
    Intervention: Dietary Supplement: Rosehip powder

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact: Henning Bliddal, Professor +45 38164158 hb@frh.regionh.dk
Contact: Robin Christensen, MSc, PhD +45 38164158 Robin.christensen@frh.regionh.dk
Denmark
 
NCT01430481
H-1-2011-018
No
Henning Bliddal, Frederiksberg University Hospital
Frederiksberg University Hospital
  • Axellus A/S, Ishøj, Denmark
  • Oak Foundation, Geneva
Principal Investigator: Henning Bliddal, Professor The Parker Institute, Frederiksberg Hospital, Denmark
Frederiksberg University Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP