Clinical trial NCT01459939: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Activities of Daily Living
Quality of Life
Keywords: Osteoarthritis
Lead sponsor: Hyben Vital ApS
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: difference in the effect by using WOMAC-pain score.
timeFrame: 12 weeks
measure: difference in the effect by using WOMAC-ADL score
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 12 weeks
measure: Difference in the effect by using WOMAC-pain score
timeFrame: 6 weeks
measure: Patient assessment of the disease
timeFrame: 12 weeks
measure: difference in the effect by using WOMAC-ADL (Activities of Daily Living)score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: INCUBA Science Park - Skejby
Study officials:
affiliation: Aarhus University Hospital
name: Frank Pedersen, Dr
role: PRINCIPAL_INVESTIGATOR
References: