CTRI/2022/03/040964招募中2/3 期
A Clinical study to evaluate the efficacy and safety of nutraceutical formulation in neurodegenerative diseases linked to cognitive impairment
适应症
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- CSIR
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Mini-mental examination score from 1st day i.e. baseline to 12th week.
研究概览
简要总结
Data will be published after completion of trial as soon as possible . Two groups will be studied and the outcome of study will be analyzed with appropriate statistical tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Mild and moderate subjective symptoms of memory impairment.
- •2.Age of patient :50-80 years.
- •3.A previous diagnosis of early dementia or MCI with a score of >9 and <23 on the mini-mental state examination 4.The ability and willingness to provide informed consent.
排除标准
- •1.A screening MMSE score of <9(indicating severe memory impairment.) 2.Known neuropsychiatric conditions.
- •3.Uncontrolled hypertension or diabetes mellitus.
- •4.Drug dependence or addiction.
- •5.Use of alcohol, psychotropic drugs or alternative medicines for memory.
- •6.Subject with concurrent Hepatic dysfunction.
- •7.Subjects suffering from major systemic illness necessitating long term drug use (R.A.,T.B.) 8.Any other condition which the investigator thinks may compromise the safety.
- •9.Subjects with established diagnosis of CAD requiring any procedure in next 6 months -angioplasty or bypass surgery or any other clinically significant cardiovascular disease.
- •10.Already known hypersensitivity to any interventional drug.
- •11.Patients who have participated in any clinical trial during past 6 months.
结局指标
主要结局
Change in Mini-mental examination score from 1st day i.e. baseline to 12th week.
时间窗: 84 days
次要结局
- Change in SF-36 Health Survey score from 1st day i.e. baseline to 12th week.(12 weeks)
研究者
研究点 (1)
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