A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of ViphyllinTM on Brain Health and Cognitive function in Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean change in cognitive function parameters
研究概览
简要总结
This is a randomized (1:1), double-blind, placebo-controlled, parallel group clinical study. Healthy subjects aged 35-60 years with normal cognition assessed by Mini-Mental State Examination (MMSE) and meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms to receive ViphyllinTM or placebo in 50:50 ratio.
The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments including biomarker analysis . The subjects will also undergo assessments to evaluate their cognitive functions. The subjects will visit their designated study site on 4 different occasions during the 12-week study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with a MMSE Score ≥ 23
- •Diabetes, hypertension and other medical condition patients should be on stable medication for last 3 months
- •Should not be an any medication for cognition and other neurological disorders
- •Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
- •Non-smokers
- •Able to communicate verbally, able to write and speak English and comfortable with using computer
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Subjects with history of -Respiratory bacterial or viral infection (including COVID-19) in the past 2 weeks.
- •Psychiatric disorders.
- •Severe neurological diseases or seizures.
- •Uncontrolled / serious medical illness including diabetes, liver disease, hypertension.
- •Cardiac Disease/Neurological Problems/.
- •Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes) -Gastrointestinal tract bleeding / peptic ulcer disease
- •Subjects who maybe allergic to any of the natural constituents of the Investigational Product.
- •Known HIV or Hepatitis B positive or any other immuno-compromised state
- •Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime.
- •Subjects visually or mentally handicapped or having difficulty to communicate
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
结局指标
主要结局
Mean change in cognitive function parameters
时间窗: Day 0, 42 and 84
次要结局
- Mean change in the biomarker levels(Day 0,42 and 84)
- Over all Safety(Day 0, 42 and 84)