An investigation into the effects of curcumin on osteoarthritis of the knee

Not Applicable

Completed

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12620000976987
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-30
• Study Completion: 2021-04-16
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified