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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Activities of Daily Living, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Rose-hip powder capsules
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Daily treatment with placebo | Dietary Supplement: Placebo<br>* 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<br>|
| Active Comparator: Rose-hip powder<br>Daily treatment with Rose-hip powder | Dietary Supplement: Rose-hip powder capsules<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis