CTRI/2023/03/050974已完成1/2 期
A Randomized, Double Blind, Placebo Controlled Pilot Study to Evaluate the Effect of Ashwagandha (Withania somnifera) Extract in improving memory in adults with mild cognitive impairment
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wechsler Memory Scale –III (WMS-III) Score
研究概览
简要总结
The study is designed to evaluate the effect of ashwagandha extract ti omprove memory. Participants meeting inclusion/exclusion criteria are enrolled into the study and randomized to receive either test product or placebo. Participants will be assessed using memory scales at Baseline. The participants will be given investigational products for 60 days at a dose of 250mg/day. Memory assessment will be done after 30 and 60 days after intake of investigational products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 25 to 65 years
- •Participants with mild, subjective symptoms of memory impairment
- •Participants with no impairment in Social and Occupational Functioning
- •Instrumental Activities of Daily Life (IADL) score > 6
- •Montreal Cognitive Assessment (MoCA) Score 18-25
- •Clinical Dementia Rating (CDR) Global score < 0.5
- •Vitamin B12 (Serum) 200-900pg/mL.
排除标准
- •Known neuropsychiatric conditions including depression
- •Persistent endocrine disorders
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Drug dependence or addiction
- •Use of alcohol
- •Psychotropic drugs or drugs or alternative medicines for memory enhancement, or any severe comorbid medical condition.
- •Pregnant or lactating women and
- •Subjects with known hypersensitivity to ashwagandha
- •Other than ashwagandha in the treatment group, the use of nootropic agents or anticholinesterase drugs will be prohibited during the study.
- •History of significant brain disorders (e.g., stroke or epilepsy);
- •Use of any type of dementia-delaying medication;
- •Head trauma with post-traumatic loss of consciousness for at least 30 min during the lifespan
- •Brain damaged patients (brain tumour; penetrating head injury; closed head injury; cerebral vascular accident; cerebral abscess; cerebral atrophy; subdural hematoma; temporal lobectomy for epilepsy; dementia paralytica; congenital anomaly of brain).
结局指标
主要结局
Wechsler Memory Scale –III (WMS-III) Score
时间窗: Baseline, Day 30, Day 60
Shepard Mental Rotation Task Score
时间窗: Baseline, Day 30, Day 60
次要结局
- Montreal Cognitive Assessment (MoCA)(Mini-mental state examination (MMSE))
研究者
研究点 (1)
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