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
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Dietary Supplement: Rosehip powder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Different Preparations and Dosages of Rosehip Powder in Patients With Painful Osteoarthritis of the Knee: An Exploratory Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: August 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
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)
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
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)
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430481

Contacts
Contact: Henning Bliddal, Professor +45 38164158 hb@frh.regionh.dk
Contact: Robin Christensen, MSc, PhD +45 38164158 Robin.christensen@frh.regionh.dk

Locations
Denmark
The Parker Institute, Frederiksberg Hospital Recruiting
Frederiksberg, Denmark, 2000
Contact: Line Rustad, Project assistant    +45 38164158    line.rustad@frh.regionh.dk   
Contact: Claus Bomhoff, Res.Manager    +45 38164158    cb@frh.regionh.dk   
Sub-Investigator: Robin Christensen, MSc, PhD         
Sponsors and Collaborators
Frederiksberg University Hospital
Axellus A/S, Ishøj, Denmark
Oak Foundation, Geneva
Investigators
Principal Investigator: Henning Bliddal, Professor The Parker Institute, Frederiksberg Hospital, Denmark
  More Information

Publications:
Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01430481     History of Changes
Other Study ID Numbers: H-1-2011-018
Study First Received: August 29, 2011
Last Updated: September 7, 2011
Health Authority: Denmark: 'The Capital Region of Denmark'

Keywords provided by Frederiksberg University Hospital:
rosehip
osteoarthritis
pain
knee
RCT

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014