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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
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
INCUBA Science Park - Skejby
Aarhus, Denmark
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.
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 weeks
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