None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 adults who are currently experiencing osteoarthritis of the knee will be randomly assigned to receive capsules containing either a curcumin extract (1000mg a day) or placebo for 8 weeks. We will assess changes in knee pain and quality of life via validated self-report measures (to be completed at various time points throughout the study). We will also evaluate pre and post changes in functional/physical performance via several performance-based tests.
Interventions
Condition 1: Placebo capsules (1 capsule twice daily for 8 weeks)
Condition 2: Curcumin extract (Curcugen) (1 capsule containing 500mg, twice daily, delivering 1000mg a day, for 8 weeks)
Adherence to capsule intake will be monitored through capsule return and count.
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 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male and females aged 45 to 70 years 2. Meets the National Institute for Health and Care Excellence (NICE) clinical criteria for diagnosing knee osteoarthritis: a. age 45 years or older b. has activity-related knee joint pain c. has morning knee stiffness that lasts no longer than 30 minutes 3. Knee osteoarthritis (diagnosed by a medical professional) 4. Reports knee pain on most days over the previous month 5. Has experienced knee pain for 3 months or more 6. Reports an average pain score of at least 6 on an 11-point numeric rating scale during walking over the previous week (0=no pain, 10=worst pain possible) 7. BMI between 20 and 35 8. Non-smoker 9. English speaking 10. No plan to commence new treatments over the study period 11. Willing to provide a personally-signed informed consent form detailing all pertinent aspects of the trial. 12. Willing and able to take prescribed capsules for 8 weeks
Exclusion criteria
1. Experience of rapid worsening of knee symptoms or the presence of a hot swollen knee 2. Previous knee replacement on the affected side or history of significant trauma to the knee 3. Has had major surgery in the last year 4. Has had a joint injection or arthroscopy in the past 6 months 5. Current or past (3 months) use of pain-relieving medications (e.g., NSAID’s, analgesics, and corticosteroids) greater than twice a week 6. Use of anticoagulants e.g. warfarin, apixaban, ticagrelor, rivaroxaban, dabigatran within the preceding 3 months 7. Diagnosis of gout or pseudogout within the last 3 months, and/or history of gout in the knee joint 8. Diagnoses of other inflammatory arthritides (for example, rheumatoid arthritis), septic arthritis, or malignancy (bone pain) 9. Diagnosis of complex pain disorder or severe immobility (e.g. complex regional pain syndrome, severe back pain, multiple sclerosis, muscular dystrophy, Parkinson’s disease, hemiplegic) 10. A recent diagnosis of and/or currently suffering from unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease/gallstones/biliary disease, endocrine disease, and malignancies 11. Diagnosis of a neurological disease (e.g., Parkinson’s disease, Alzheimer’s disease, intracranial haemorrhage, multiple sclerosis, or head/brain injury), psychiatric disorder (other than mild-to-moderate depression/anxiety) 12. Unable to walk unaided (without the use of a frame or walking stick) or is house-bound due to immobility 13. Alcohol consumption > 14 standard drinks per week 14. Current or 12-month history of illicit drug abuse 15. Currently taking supplements that may impact on treatment outcome (e.g. chondroitin, glucosamine, or curcumin) 16. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
Outcome results
None listed