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