None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 adults aged 40 to 75 years with knee osteoarthritis will be randomly assigned to receive either topical administrations of a gel containing curcumin (VAS101) or a placebo. These gels will be applied every 2 days for 28 days. Changes in knee pain and osteoarthritis symptoms will be examined using validated self-report measures, several performance-based tasks, and a urinary marker associated with disease progression in osteoarthritis. Changes in the use of rescue medications for knee pain will also be examined over time. It is hypothesised that compared to the placebo gel, the application of VAS101 will be associated with a greater reduction in knee pain and other knee-related osteoarthritis symptoms; and larger improvements in several performance-based tasks.
Interventions
The topical application of 0.1 millilitres of a gel containing curcumin (VAS101) to the target knee, once every 2 days for 28 days. Adherence to application will be monitored through daily responses to a questionnaire.
The the target knee (the knee to be treated in the trial) is the most painful knee. If both knees have similar pain, the most dominant leg will be established as the target knee and must meet all the eligibility criteria.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female 2. Aged 45 to 75 years (inclusive) 3. Clinical knee OA defined according to the National Institute for Health and Care Excellence (NICE) clinical criteria a. age 45 years or older b. has activity-related knee joint pain c. has no morning knee stiffness or stiffness of 30 minutes or less 4. Body mass index (BMI) between 18.0 and 32.0 kg/m2 5. A previous diagnosis of knee OA by a medical practitioner 6. The knee OA can be unilateral or bilateral, but for participants with bilateral knee OA, the target knee (the knee to be treated in the trial) is the most painful knee. If both knees have similar pain, the most dominant leg will be established as the target knee and must meet all the eligibility criteria 7. At the time of screening, reports a knee pain rating of 4 to 7 on a 10-point numeric rating scale (1=no pain, 10=worst pain possible) to the following question: “Over the last week, what is your average knee pain while walking (1=no pain, 10=worst pain possible)” 8. Reports experiencing knee pain on more than 50% of days over the previous month 9. No plan to commence new treatments over the study period 10. Understand, willing and able to comply with all study procedures 11. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial
Exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to hyper/hypotension, cardiovascular disease, diabetes, gastrointestinal disease, endocrine disease, neurological disease, cancer/ malignancy or other conditions that would jeopardise safety or impact validity of results (in the opinion the Investigator) 2. Suffers from arthritis of the hip or has chronic back pain that significantly affects daily function 3. Intra-articular treatment/injections with a corticosteroid or hyaluronic acid within 6 months before screening 4. Any surgery on the target knee within 6 months before screening 5. Any planned surgery during the study period 6. Clinically significant infection, injury, or illness within 28 days before screening 7. Planning to engage in heavy exercise (e.g., marathon run, heavy leg squats) within 48 hours before screening or during the study 8. Known allergic reaction to curcumin-containing products 9. Injury in the area of the target knee within 3 months before screening 10. Taking curcumin-containing products 11. Commencement of, or change in medication, herbal or vitamin supplements within 4 weeks before screening 12. Alcohol intake greater than 14 standard drinks per week 13. Current or 12-month history of regular illicit drug use 14. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant in the next 2 months.
Outcome results
None listed