ACTRN12618000080224已完成3 期
A randomised trial of Curcuma longa for treating symptoms and effusion-synovitis of knee osteoarthritis.
niversity of Tasmania0 个研究点目标入组 70 人开始时间: 2018年1月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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