Official Title
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
Phase
Phase 3Lead Sponsor
Hyben Vital ApSStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Pain Activities of Daily Living Quality of LifeIntervention/Treatment
rosehip ...Study Participants
120The 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.
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
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
Daily treatment with Rose-hip powder
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.
