NCT01203670已完成不适用
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
Phythea2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Renal tolerance by Glomerular filtration rate (GFR) determination; Digestive tolerance by Aspartate Amino transferase (ASAT), Alanine Amino Transferase (ALAT), gamma Glutamyl Transpeptidase (gamma GT), lipase and amylase determination
研究概览
简要总结
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 87 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years old minimum
- •Satisfying general health judged by principal investigator
- •Pain and /or stifness associated with arthritis
- •Regular used of analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs)
- •Digestive tolerance biomarkers
- •ASAT : Men < 150 UI/L - Women < 100 UI/L
- •ALAT : Men < 180 UI/l - Women < 130 UI:l
- •Gamma GT Men < 180 UI/l - Gamma GT Women < 100 UI/l
- •Amylase < 250 UI/l
- •Lipase < 750 UI/l
- •Renal tolerance biomarker: Glomerular filtration rate (GFR)superior or equal to 60 mL /min / 1.73m3 - calculated with the "Modification of the Diet in Renal Diseases" formula
排除标准
- •Inflammatory arthritis
- •Allergy to any constituents of the study drug
- •Types 2 diabetes
- •Not legally fit to participate
- •Any treatment able to modify determined biological parameters
结局指标
主要结局
Renal tolerance by Glomerular filtration rate (GFR) determination; Digestive tolerance by Aspartate Amino transferase (ASAT), Alanine Amino Transferase (ALAT), gamma Glutamyl Transpeptidase (gamma GT), lipase and amylase determination
时间窗: 168 days
次要结局
- Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)(168 days)
研究者
研究点 (2)
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