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OpenTrials
Completed

NCT Number: NCT01430481

Rosehip Powder for Knee Osteoarthritis

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Parker Institute, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Rosehip, Litomove, Litozin, HybenVital

Primary outcomes

  1. Pain, Walking on flat surface - range: 0-100

    Time frame: week 12

    Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item

Secondary outcomes

  1. Pain - range: 0-100

    Time frame: week 12

    KOOS

  2. Symptoms - range: 0-100

    Time frame: week 12

    KOOS

  3. Function in daily living - range: 0-100

    Time frame: week 12

    KOOS

  4. Knee related Quality of life - range: 0-100

    Time frame: week 12

    KOOS

  5. VAS Pain - 0-100

    Time frame: week 12

    VAS

  6. VAS Disability - 0-100

    Time frame: week 12

    VAS

  7. VAS patient global assessment of disease status - 0-100

    Time frame: week 12

    VAS

  8. VAS physician global assessment of disease status - 0-100

    Time frame: week 12

    VAS

  9. Physical component summary - range: 0-100

    Time frame: week 12

    Short-Form-36 score

  10. Mental component summary - range: 0-100

    Time frame: week 12

    Short-Form-36 score

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Collaborators

  • Axellus
  • Oak Foundation

Registry information

Official study title

Comparing Different Preparations and Dosages of Rosehip Powder in Patients With Painful Osteoarthritis of the Knee: An Exploratory Randomised Controlled Trial

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 8, 2011
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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