Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Daily treatment with placebo |
|
| Rose-hip powder | Active Comparator | Daily treatment with Rose-hip powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rose-hip powder capsules | Dietary Supplement | 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 |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Pedersen, Dr | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INCUBA Science Park - Skejby | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41599942 | Derived | Motawei AM, Warholm KM, Winther K. Using Dose-Response Correlation Re-Analyzing to Distinguish Placebo from Standardized Rose-Hip Powder (Lito) in a Clinical Trial on Osteoarthritis Where Data Initially Looked Identical. Nutrients. 2026 Jan 20;18(2):331. doi: 10.3390/nu18020331. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | 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 |
|
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 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided