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

Phase 3

Completed

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

• Registration Number: ACTRN12618000080224
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-19
• Study Completion: 2019-03-15
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in knee pain (assessed by 100mm VAS) over 12 weeks in patients with clinical knee OA[Mixed model accounting for the overall change (slope of the knee pain graph from baseline <br> though weeks 4, 8 and ending at week 12) in knee pain from baseline.];Change in effusion-synovitis size from baseline to 12 weeks measured using MRI quantitative measurements in patients with symptomatic OA of the knee and knee effusion-synovitis.[MR Imaging at baseline and week 12]