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Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial

F

Frederiksberg University Hospital

Status and phase

Completed
Phase 4

Conditions

Knee Related Walking Limitations

Treatments

Dietary Supplement: Rosehip
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Knee related mobility limitations are the leading cause of disability in the western world. It is a very expensive and debilitating condition when the cost of lost productivity and personal assistance is considered.

In recent years there has been a growing interest in alternative medicine and many individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been particular popular, and has been shown effective in relieiving pain - albeit the evidence is scarce.

The purpose of this study is to evaluate the efficacy of specialized rosehip powder nutritional additives (Rosenoids®) on knee joint function during walking in subjects with knee-related walking limitations.

Enrollment

100 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged above 40
  • Self-reported knee-related walking disability
  • In general good health, in the opinion of the Investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the Investigator at the screening visit.
  • A body mass index (BMI) of ≤35 kg/m2
  • Speaks, reads and writes Danish language

Exclusion criteria

  • Usage of Rosehip nutritional supplements within the last 3 months
  • History of symptoms of autoimmune disorders.
  • Planned surgical procedure during the duration of the study
  • History, diagnosis, or signs and symptoms of clinically significant neurological disease
  • Alcohol or drug abuse within the last 5 years
  • History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
  • Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.
  • Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

Rosehip
Experimental group
Description:
Dosage: 3 capsules once daily with meals (daily dose: 2.25 g powder).
Treatment:
Dietary Supplement: Rosehip
Placebo
Placebo Comparator group
Description:
Dosage: 3 capsules once daily with meals
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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