CTRI/2019/11/021990已完成不适用
A Prospective Double-Blind, Randomized, Multi-Center, Parallel-Group, Two-Arm, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ashwagandha Root Extract Sustained Release Capsule 300 mg on Cognitive Functions in Healthy, Adult Stressed Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change from Baseline to the end of the study period in cognition as measured by CANTAB connect.
研究概览
简要总结
Total 130 subjects will be enrolled in the study. They will be divided in to two arms.i.e active and placebo arm and followed up for 3 months. The primary objective of the study will be to assess the subtle changes in cognitive domain as measured by The Cambridge Neuropsychological Test Automated Battery (CANTAB) connect.
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
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Body Mass Index 18 to 29 kg/m
- •2.Healthy subjects as determined by: Medical history, Physical examination and clinical judgment of the investigator 3.Subjects who perceive themselves to be under stress and having a score of 14-24 on the Perceived Stress Scale (PSS).
- •4.Cognitively sound (no cognitive impairment) subjects as identified with Montreal Cognitive Assessment (MoCA) test.
- •5.Subjects willing and able to provide written informed consent and agree to come for regular follow up.
- •6.Subject willing to comply with all study related procedures and requirements.
排除标准
- •1.Female subjects who are pregnant or lactating or planning to become pregnant and / or unwilling to follow standard contraception methods.
- •2.Post- menopausal female subjects 3.Subjects with education level below 8th grade of schooling and unable to read or understand English.
- •4.History of drug dependence or any severe co-morbid medical conditions.
- •5.History or presence of any clinically significant systemic disease including but not limited to psychiatric, cardiovascular, pulmonary, neurological, hepatic, renal, metabolic, ophthalmologic, or any other medical condition including but not limited to uncontrolled hypertension, stroke, epilepsy, myocardial infarction, coronary artery disease, cardiac failure, type I or type II Diabetes Mellitus, renal or hepatic failure, sexually transmitted diseases (STDs),Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) 6.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •7.Subjects with significant medication use including but not limited to (psychotropic, antihypertensive, beta-blockers, inhaled beta agonists, corticosteroid use within prior three months.) 8.Subjects on high alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/ Nicotine or Caffeine dependence.
- •9.Subjects on multivitamins/herbal supplements/ any other wellness product 10.Subject who has participated in a clinical study within the last 30 days prior to entering this study.
- •11.Subject with hypersensitivity to any of the ingredients of the study products.
结局指标
主要结局
Change from Baseline to the end of the study period in cognition as measured by CANTAB connect.
时间窗: Day 0 & Day 90
次要结局
- Change from Baseline to the end of the study period in:(1. Perceived Stress Scale- 10 (PSS-10) score)
研究者
研究点 (2)
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