Status:
COMPLETED
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
Lead Sponsor:
Hyben Vital ApS
Conditions:
Pain
Activities of Daily Living
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 cons...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01459939
Start Date
October 1 2011
End Date
May 1 2012
Last Update
June 6 2012
Active Locations (1)
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1
INCUBA Science Park - Skejby
Aarhus, Denmark, 8200