Rosehip Powder for Knee Osteoarthritis

Frederiksberg University Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Osteoarthritis

Interventions

Rosehip powderDIETARY_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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Parker Institute, Frederiksberg Hospital

Frederiksberg, Denmark

Outcomes

Primary Outcomes

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

Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item

Time frame: week 12

Secondary Outcomes

Pain - range: 0-100

KOOS

Time frame: week 12

Symptoms - range: 0-100

KOOS

Time frame: week 12

Function in daily living - range: 0-100

KOOS

Time frame: week 12

Knee related Quality of life - range: 0-100

KOOS

Time frame: week 12

VAS Pain - 0-100

VAS

Time frame: week 12

VAS Disability - 0-100

VAS

Time frame: week 12

VAS patient global assessment of disease status - 0-100

VAS

Time frame: week 12

VAS physician global assessment of disease status - 0-100

VAS

Time frame: week 12

Physical component summary - range: 0-100

Short-Form-36 score

Time frame: week 12

Data from ClinicalTrials.gov

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