Rosehip Powder for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Rosehip powder


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Rosehip Powder (A)<br>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<br>* 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.<br>* Other names: HybenVital;|
| Experimental: New rosehip formulation (B)<br>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<br>* 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.<br>* Other names: HybenVital;|
| Experimental: New rosehip formulation in half dose (C)<br>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<br>* 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.<br>* Other names: HybenVital;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Walking on flat surface - range: 0-100 | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - range: 0-100 | KOOS | week 12 | 
| Symptoms - range: 0-100 | KOOS | week 12 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosehip, osteoarthritis, pain, knee, RCT