Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes of VFT
研究概览
简要总结
The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment
详细描述
Inclusion criteria is cerebrovascular insufficiency MNSE>20. 90 patients are divided into three groups randomly. First group is being administered 120 mg ginkgo biloba extract, second group 60 mg of the extract and the third group has being administered placebo during the period of 6 months. Methods used for evaluation are SCAG, MMSE, MDRS, VFT, CGI, TCD and color Doppler of carotid arteries. Methods used for follow up safety include: routine blood tests, biochemical tests, neurologic and physical examination, vital signs and ECG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cerebrovascular insufficiency and mild cognitive disorder (MMSE=20-28)
排除标准
- •pregnancy
- •cognitive disorder caused by psychological, metabolic endocrine nutritional and heart disorder
- •alcohol or drug abuse
研究组 & 干预措施
1
Ginkgo Biloba standardized extract 24/6
干预措施: Ginkgo Biloba standardized extract 24/6 (Drug)
3
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Changes of VFT
时间窗: 6 months
Changes of CGI
时间窗: 6 months
Changes of SCAG
时间窗: 6 months
Changes of MMSE
时间窗: 6 months
Changes of MDRS
时间窗: 6 months
次要结局
- Changes of TCD, and color Doppler of carotid arteries(6 months)
- Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time(6 months)
- Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides(6 months)
- Safety will be assessed according to occurrence of adverse events during the trial(6 months)
研究者
Professor of Neurology Vida Demarin, MD, PhD
MD, PhD, FAAN, FAHA, FESO Fellow of Croatian Academy of Sciences and Arts Professor of Neurology
Milsing d.o.o.