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

NCT01459939 | Completed Phase 3

• 1 other identifier: HV 01/11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Activities of Daily Living; Quality of Life

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• difference in the effect by using WOMAC-pain score.

  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.

  12 weeks

• difference in the effect by using WOMAC-ADL score

  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.

  12 weeks

Secondary Outcomes (4)

• Quality of life

  12 weeks

• Difference in the effect by using WOMAC-pain score

  6 weeks

• Patient assessment of the disease

  12 weeks

• difference in the effect by using WOMAC-ADL (Activities of Daily Living)score

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Daily treatment with placebo

Dietary Supplement: Placebo

Rose-hip powder

ACTIVE COMPARATOR

Daily treatment with Rose-hip powder

Dietary Supplement: Rose-hip powder capsules

Interventions

Rose-hip powder capsules DIETARY_SUPPLEMENT

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

Rose-hip powder

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyben Vital ApS: lead

Study Sites (1)

INCUBA Science Park - Skejby

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Motawei AM, Warholm KM, Winther K. Using Dose-Response Correlation Re-Analyzing to Distinguish Placebo from Standardized Rose-Hip Powder (Lito) in a Clinical Trial on Osteoarthritis Where Data Initially Looked Identical. Nutrients. 2026 Jan 20;18(2):331. doi: 10.3390/nu18020331.

  PMID: 41599942 DERIVED

MeSH Terms

Conditions

Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Frank Pedersen, Dr

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

DK (1)