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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyben Vital ApS
ClinicalTrials.gov Identifier:
NCT01459939
First received: October 24, 2011
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Activities of Daily Living
Quality of Life
 Dietary Supplement: Rose-hip powder capsules
Dietary Supplement: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Hyben Vital ApS:

Primary Outcome Measures:
  • difference in the effect by using WOMAC-pain score. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Difference in the effect by using WOMAC-pain score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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

  • Patient assessment of the disease [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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


  • difference in the effect by using WOMAC-ADL (Activities of Daily Living)score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 120
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Daily treatment with placebo
 Dietary Supplement: 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
Active Comparator: Rose-hip powder
Daily treatment with Rose-hip powder
 Dietary Supplement: 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
Other Name: Rose-hip powder capsules

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459939

Locations
Denmark
INCUBA Science Park - Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
Hyben Vital ApS
Investigators
Principal Investigator: Frank Pedersen, Dr Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Hyben Vital ApS
ClinicalTrials.gov Identifier: NCT01459939     History of Changes
Other Study ID Numbers: HV 01/11
Study First Received: October 24, 2011
Last Updated: June 5, 2012
Health Authority: Denmark: Central Scientific Ethics Committee

Keywords provided by Hyben Vital ApS:
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013