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
NCT ID: NCT01459939
Last Updated: 2012-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2011-10-31
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rosehip Powder for Knee Osteoarthritis
NCT01430481
Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial
NCT01927848
A Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.
NCT02604381
Study of Diclofenac Capsules to Treat Osteoarthritis Pain
NCT01461369
Intraarticular Gold Microparticles for Hip Osteoarthritis
NCT06186115
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Daily treatment with placebo
Placebo
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
Rose-hip powder
Daily treatment with Rose-hip powder
Rose-hip powder capsules
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rose-hip powder capsules
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
Placebo
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hyben Vital ApS
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frank Pedersen, Dr
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
INCUBA Science Park - Skejby
Aarhus, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HV 01/11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.