ACTRN12615000149561已完成3 期
A double-blind, randomised, placebo-controlled study on the safety and efficacy of Palmitoylethanolamide (PEA) for management of mild to moderate osteoarthritis symptoms
Integrated Health Group Pty. Ltd.0 个研究点目标入组 120 人开始时间: 2015年2月17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
- 120
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 75 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •Medically diagnosed Osteoarthritis
- •VAS Pain greater than 4
- •Not using daily prescribed Osteoarthritis medication
- •Males and females 40-75 years of age
- •BMI between 18.5 - 35
排除标准
- •Exclusion Criteria
- •All other forms of arthritis and other auto-immune issues
- •Significant joint injury within last 6 months
- •Women that are pregnant or breast feeding
- •Uncontrolled diagnosed serious health conditions such as diabetes, high cholesterol, hypertension, osteoporosis or have digestive disease(s).
- •Known hypersensitivity to herbal drugs/nutritional supplement/ foods
- •Have started used a drug/natural therapy for Osteoarthritis within the last 30 days – Including Fish oil/ Omega 3 supplement
- •Receiving/ prescribed coumandin (Warfarin) or other anticoagulation therapy
- •Current or history of chronic alcohol and/or drug abuse
- •History of cerebrovascular accident, stroke, or transient ischemia.
- •Major depressive disorders, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
- •Currently using other investigational product(s).
- •Have experienced unintended weight loss of more than 15% of body weight in last 6 months.
- •Active substance abuse (alcohol or drug dependency).
研究者
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