A randomised trial of Curcuma longa for treating symptoms and effusion-synovitis of knee osteoarthritis.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000080224

Acronym

CurKOA Trial

Enrollment

Registered

2018-01-19

Start date

2018-06-12

Completion date

2018-12-21

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Osteoarthritis is a common joint disorder for which there is no cure. Curcuma longa (commonly known as Turmeric) has anti-inflammatory, cartilage and bone protective properties, and can potentially be used to treat osteoarthritis patients with an inflammatory form of osteoarthritis. Previous studies of Curcuma longa have been of dubious quality and did not select patients with knee swelling, which is a clinical indication of inflammation. The aim of this clinical trial is to determine the efficacy of Curcuma longa extract for treating knee osteoarthritis symptoms and effusion-synovitis (assessment of excess joint fluid using MRI). If successful, treatment with Curcuma longa can be easily implemented as it is inexpensive, safe and available over-the-counter.

Interventions

35 patients with clinical knee osteoarthritis, significant knee pain and effusion-synovitis on imaging will receive 1g (2 capsules of 500mg each) of Curcuma longa extract per day for 12 weeks. Adherence to treatment will be monitored by counting the returned capsules at the 12 week visit.

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

40 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Aged over 40 years old. 2. Men and women with significant knee pain on most days (defined as a VAS >40mm). 3. Knee effusion–synovitis on US (>=4mm thickness measure). 4. Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a clinician.

Exclusion criteria

1. Inability to have an MRI (claustrophobia, metal in eyes or selected knee, pacemakers). 2. Severe knee OA (joint space narrowing (JSN) on X-ray of Grade 3 using the Osteoarthritis Research Society International (OARSI) atlas). 3. Unwillingness to stop taking Curcuma longa medications 2 weeks prior to randomization 4. Other forms of inflammatory arthritis (especially rheumatoid arthritis and gout). 5. Significant knee injury within the last 6 months. 6. Arthroscopy or open surgery in the index knee in the last 12 months, or planned. 7. Injections of corticosteroids (last 3 months) or hyaluronic acid (last 6 months) in the index knee. 8. Pregnancy or breastfeeding. 9. Use of any investigational drug(s) and/or devices within 30 days prior to randomisation 10. Presence of any serious medical illness that may preclude 24 week follow up. 11. Inability to provide informed consent. 12. Study Investigators consider the patient is otherwise unsuitable for the study including the assessment of kidney function for a contrast-enhanced MRI study.

Outcome results