PainPhase 3NCT01459939
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
A Phase 3 study testing Rose-hip powder capsules in people with Pain and Activities of Daily Living, run by Hyben Vital ApS at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Activities of Daily Living, Quality of Life
- What is being tested?
- Rose-hip powder capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Pain, Activities of Daily Living, Quality of Life
- Being tested
- Rose-hip powder capsules, Placebo
- Keywords
- Osteoarthritis
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rose-hip powder capsulesDietary 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
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily treatment with placebo Receives: Dietary Supplement: Placebo |
| Rose-hip powder | Active comparator | Daily treatment with Rose-hip powder Receives: Dietary Supplement: Rose-hip powder capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyben Vital ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Pedersen, Dr, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459939
- Sponsor's protocol ID
- HV 01/11
- Status last verified
- Jun 2012
- First submitted
- 24 Oct 2011
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41599942
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01459939
- Acronym / sponsor ID
- HV 01/11
- Conditions
- Pain, Activities of Daily Living, Quality of Life
- Keywords
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hyben Vital ApSIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily treatment with placebo |
| Rose-hip powder | Active comparator | Dietary Supplement: Rose-hip powder capsulesDaily treatment with Rose-hip powder |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rose-hip powder capsules5 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 | Dietary supplement | Rose-hip powder |
| Placebo5 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 | Dietary supplement | Placebo |
Primary outcome
difference in the effect by using WOMAC-pain score.
Time frame: 12 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 3 months of treatment between active treatment and placebo group, and between baseline and 3 months.
difference in the effect by using WOMAC-ADL score
Time frame: 12 weeks
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.
4 secondary outcomes
Quality of life
Time frame: 12 weeks
Difference in the effect by using WOMAC-pain score
Time frame: 6 weeks
Patient assessment of the disease
Time frame: 12 weeks
difference in the effect by using WOMAC-ADL (Activities of Daily Living)score
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- Derived from this study: PubMed 41599942Motawei 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Pedersen, Dr principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rose-hip powder capsules in people with Pain and Activities of Daily Living, run by Hyben Vital ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the effect by using WOMAC-pain score. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.