Dietary Supplement for Joint: the OLE Study (NCT03072108) | Clinical Trial Compass
CompletedNot Applicable
Dietary Supplement for Joint: the OLE Study
Belgium124 participantsStarted 2016-06-24
Plain-language summary
This clinical study evaluates if the oral administration of Bonolive can contribute to the improvement of functionnality in healthy elderly people with knee discomfort.
Who can participate
Age range55 Years
SexALL
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Inclusion Criteria:
* Male or female ≥ 55 years of age
* BMI between 18.5 and 29.9 kg/m2 (normo and overweight)
* Moderate knee pain (the most painful knee is considered)
* Able to follow the instructions of the study
* Able to perform physical tests
* Having signed an informed consent
Exclusion Criteria:
Related to knee
* Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
* Subject with knee/joint surgery/replacement and ACL (Cross Ligament) injury in the target knee
* Concurrent articular disease interfering with the evaluation of pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis
* Prosthesis in the target knee
* Diagnosed arthrosis eligible to knee/joint surgery/replacement
Related to treatments
* Analgesics to manage knee pain 24h before inclusion visit
* Corticosteroids injection in the target knee in the month preceding inclusion
* Hyaluronan injection in the target knee in the last 6 months
* Oral corticotherapy ≥ 5mg/day in the last 3 months
* Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
* Other dietary supplements used for articular disorders in the last 3 months
* An anticipated need for the…
What they're measuring
1
Evaluation of the effect of investigational product after 6 months of supplementation
Timeframe: From Baseline to 6 months of product administration and compared to Placebo
2
Evaluation of the effect of investigational product after 6 months of supplementation
Timeframe: From Baseline to 6 months of product administration and compared to Placebo