ACTRN12620000976987Completed未知
An investigation into the effects of curcumin on osteoarthritis pain of the knee: a randomised, double-blind, placebo-controlled study
Clinical Research Australia0 sites101 target enrollmentStarted: September 30, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 101
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (—)
- Sex
- All
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.
Investigators
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