CTRI/2024/08/072759进行中（未招募）2 期
A Randomized, Double Blind, Placebo Controlled 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
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Mean change in MOCA
研究概览
简要总结
The study is designed to evaluate the effect of ashwagandha extract to improve memory. Participants meeting inclusion/exclusion criteria are enrolled into the study and randomized to receive either test products or placebo. Participants will be assessed using memory scales at Baseline. The participants will be given investigational products for 90 days at a dose of Ashwagandha extract 125 mg/day or Ashwagandha extract 250mg/day. Memory assessment will be done after 30 days, 60 days and 90 days after intake of investigational products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female ≥ 50 years of age with 1:1 ratio
- •Participants with mild, subjective symptoms of memory impairment
- •Participants with no impairment in Social and Occupational Functioning
- •Montreal Cognitive Assessment (MoCA) Score 18-25
- •Clinical Dementia Rating (CDR) Global score less than 0.5
- •Mini-Mental State Examination (MMSE) score 20-23
- •Vitamin B12 (Serum) 200-900pg/mL
- •Ability to follow all instructions in the study protocol and be willing to give written informed consent.
排除标准
- •1.Known neuropsychiatric conditions including depression 2.Persistent endocrine disorders 3.Uncontrolled hypertension 4.Uncontrolled Diabetes mellitus 5.Hypothyroidism 6.Drug dependence or addiction 7.Alcohol dependence 8.Psychotropic drugs or drugs or alternative medicines for memory enhancement, or any severe comorbid medical condition.
- •9.Pregnant or lactating women 10.Subjects with known hypersensitivity to ashwagandha 11.Other than ashwagandha in the treatment group, the use of nootropic agents or anticholinesterase drugs will be prohibited during the study.
- •12.History of significant brain disorders (e.g., stroke or epilepsy) 13.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) 14.Participant with a medical disorder, condition, or history such that could impair the participant’s ability to participate or complete this study in the opinion of the investigator.
- •15.Subjects who participated in a clinical trial for the past 3 months.
- •16.Unwilling to provide written informed consent.
结局指标
主要结局
Mean change in MOCA
时间窗: Baseline, Day 30, Day 60, Day 90
次要结局
- Mean change in MMSE, MSQ, WHO-5(Baseline, Day 30, Day 60, Day 90)
- Mean change in computerized cognitive tests assessed(Baseline, Day 30, Day 60, Day 90)
- Mean change in Safety profile and Biomarkers(Baseline, Day 90)
- Adverse event evaluation(Throughout the study duration)
研究者
Dr Binu T Kuruvilla
Arjuna Natural Private Limited
研究点 (3)
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