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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

NCT01459939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-06-06

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Hyben Vital ApS

    lead INDUSTRY

Principal Investigators

  • Frank Pedersen, Dr · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-02-29
Completion
2012-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01459939 on ClinicalTrials.gov