ACTRN12614000259640已完成2 期
A phase II, randomized, double-blind, placebo-controlled dose ranging pilot study investigating the efficacy and safety of supplementation with Arthrem, an extract of Artemisia annua, in improving symptoms of hip and knee osteoarthritis
Promisia Ltd0 个研究点目标入组 42 人开始时间: 2014年3月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
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
- 35 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Pain from either or both knees and/or hips on most days of the previous 3 months combined with definite radiological changes of osteoarthritis
- •- Stable dose of current regular medication for at least 4 weeks prior to study entry
- •- A minimum score on a pre-screening visual analogue pain scale of at least 30 mm on a 100 mm scale averaged over the last 7 days
排除标准
- •- Pregnancy/breastfeeding
- •- Significant renal or hepatic impairment
- •- Hip or knee surgery within past 6 months
- •- Current or recent (in the last 3 months) oral or intra-articular corticosteroid therapy;
- •- Co-morbid inflammatory arthritis such as rheumatoid arthritis
- •- History of hip or knee joint replacement or osteotomy at index joint
- •- Other previous hip or knee pathology such as a recent fracture (<3 months) or malignancy
- •- Significant illness other than osteoarthritis
- •- Taking any form of herbal/multivitamin/nutritional supplements for osteoarthritis (i.e. glucosamine, fish oil, green-lipped mussel) within 3 weeks
- •- Participation in another research study involving an investigational product in the past 12 weeks
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