NCT03658369已完成不适用
To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 8
- 主要终点
- WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score
研究概览
简要总结
The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 25 and ≤ 29.9 kg/m
- •With unilateral or bilateral OA of the knee for at least greater than 3 months, as presented by pain in the knee at least for last 3 months.
- •Post-menopausal females (LMP at least 12 months prior to the screening).
排除标准
- •History of osteoarthritis for more than 3 years.
- •Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg
- •FBS>140 mg/dl.
- •Smokers or chronic alcoholics.
- •Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.
结局指标
主要结局
WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score
时间窗: 56 days
Change in pain score.The score ranges from 0-5, wherein 0 indicates no pain and 5 indicates extreme pain.
次要结局
未报告次要终点
研究者
研究点 (8)
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