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

Hyben Vital

Status and phase

Completed

Phase 3

Conditions

Quality of Life

Activities of Daily Living

Pain

Treatments

Dietary Supplement: Rose-hip powder capsules

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01459939

HV 01/11

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.