A Double-blind, Randomized, Parallel Group, Fase III Comparative Study With Rose Hip Powder Powder and Placebo Given to Patients With Mild to Moderate Osteoarthritis in the Knee or/and Hip

The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase III study.

After the patient has receiving information about the study and after given written informed consent, the patient will be screened. All patients are randomized to receive standardized rose hip powder or matching placebo for 3 weeks followed by half the dose standardized rose hip (or placebo) for the remaining 12 weeks of the study.

The patient's medical history and demographic information will be recorded. The patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary.

Investigator or study nurse will take telephone contact with the subject after 3 and 6 weeks of treatment, subjects will be asked about how things are going and to remember to take the capsules and whether they have completed the diary.

The contact taken after 6 weeks by phone is mainly to guide the subject on how complete the questionnaires including VAS scales.

The last patient visit will take place after 12 weeks. Any side effects will be reported to and reviewed with HybenVital ApS in collaboration with medical experts.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Activities of Daily Living
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Rose-hip powder capsules

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • INCUBA Science Park - Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged 40 + years
• Osteoarthritis symptoms with duration of more than 6 months
• One WOMAC-pain visual analogue scale score (VAS score) there are at least 35 mm at rest
• Subjective morning joint stiffness
• Clinical symptoms of arthritis diagnosed by the ACR (American College Rheumatology) criteria

Exclusion Criteria:

• Patients who have been treated with rose hip extracts or powder within 3 months before screening.
• Patients who have been treated with ginger, avocado or soybean extracts or powder within 3 months before screening
• Patients on steroids, TNFalpha or DMARD prior to trial.
• Patients receiving irregular medical treatment for osteoarthritis.
• Patients suffering from other joint diseases other than osteoarthritis.
• Patients who abuse alcohol
• Patients with a current psychiatric illness, drug and / or alcohol abuse
• Patients with known allergy to rose hips
• Presence of other clinically significant medical conditions
• Patients scheduled for joint or major surgery during the trial.
• Patients participating in another clinical trial, or have participated in another clinical trial within 3 months before this study.
• Patients with known compliance problems or who are uncooperative.
• Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Daily treatment with placebo	Dietary supplement: Placebo; 5 x 0,5 g placebo powder capsules BID the first 3 weeks and decreasing to 5 x 0,5 g QD the following 9 weeks
Active Comparator: Rose-hip powder; Daily treatment with Rose-hip powder	Dietary supplement: Rose-hip powder capsules; 5 x 0,5 g rose-hip powder capsules BID the first 3 weeks and decreasing to 5 x 0,5 g QD the following 9 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in the effect by using WOMAC-pain score.	The effect of treatment within each of the two groups (Rose hip powder and placebo) measured by using the differences in WOMAC-pain scores at 3 months of treatment between active treatment and placebo group, and between baseline and 3 months.	12 weeks
difference in the effect by using WOMAC-ADL score	The effect of treatment within each of the two groups (Rose hip powder and placebo) measured by using the differences in WOMAC-ADL (Activities of Daily Living) scores at 3 months of treatment between active treatment and placebo group, and between baseline and 3 months.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Effects on QoL (SF-12 questionnaire and diaries) after 6 weeks and 12 weeks treatment, both groups compared to baseline, and the effects in the active group compared with the placebo group on QoL (SF-12 questionnaire and diaries) after 6 weeks and 12 weeks treatment.	12 weeks
Difference in the effect by using WOMAC-pain score	The effect of treatment within each of the two groups (Rose hip powder and placebo) measured by using the differences in WOMAC-pain scores at 6 weeks of treatment by compaing baseline to week 6, and the effects in the active group compared with the placebo group at 6 weeks	6 weeks
Patient assessment of the disease	Patient's assessment of the severity of the disease state is (PGAD)after 6 weeks and 12 weeks compareded to baseline and the effects in the active group compared with the placebo group at 6 and 12 weeks treatment Safety Issue?: (FDAAA) No	12 weeks
difference in the effect by using WOMAC-ADL (Activities of Daily Living)score	The effect of treatment within each of the two groups (Rose hip powder and placebo) measured by using the differences in WOMAC-ADL scores at 6 weeks of treatment by compaing baseline to week 6, and the effects in the active group compared with the placebo group at 6 weeks	6 weeks

Collaborators and Investigators

• Sponsor: Hyben Vital ApS
• Investigators: Principal Investigator: Frank Pedersen, Dr, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: HV 01/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No