跳至主要内容
临床试验/CTRI/2020/02/023297
CTRI/2020/02/023297已完成Phase 3 4

A randomized, double-blind, placebo-controlled clinical study to evaluate comparative clinical Efficacy and Safety of BHC9612CP on Cognitive Function in Adult Subjects

Botanic Healthcare Pvt Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月17日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
To study the efficacy and safety of Ashwagandha in subjects with cognitive impairment

研究概览

简要总结

Earlier clinical studies using Nutraceuticalingredients of herbal origin have demonstrated significant improvement insymptoms of CognitionBased on the existing information wehypothesized that Ashwagandha supplemented for 56 days would provide aremarkable improvement of cognition.

Cognition is defined as ‘the mental action orprocess of acquiring knowledge and understanding through thought, experience,and the senses. Cognition is the mental processes relating to the input andstorage of information and how that information is then used to guide yourbehavior. It is in essence, the ability to perceive and react, process andunderstand, store and retrieve information, make decisions and produceappropriate responses. The modern word ‘cognition’ actually has its roots backto Latin, the word ‘cognoscere’ which is to ‘get to know’. With that in mind,cognitive functioning is therefore critical for day-to-day life, governing ourthoughts and actions. We need cognition to help us understand information aboutthe world around us and interact safely with our environment, as the sensoryinformation we receive is vast and complicated: cognition is needed to distillall this information down to its essentials

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •1.Both male and female subjects aged between 40-75 years with a complaint of memory impairment for at least one year without any major cognitive deficit.
  • •2.Subjects who are willing to sign ICF.

排除标准

  • •1.Subjects with Psychiatric disorders 2.Subjects with alcohol consumption 3.Subjects with any organ system infection in past 30 days 4.Subjects with severe cognitive problems like dementia, function disability, post 5.vascular cerebral symptoms or with any neurological problems.

结局指标

主要结局

To study the efficacy and safety of Ashwagandha in subjects with cognitive impairment

时间窗: Day 0 Day 28 and Day 56

次要结局

  • 1.Adverse events (AEs), frequency and severity.(2.Number of subjects who discontinue study due to adverse events)

研究者

发起方
Botanic Healthcare Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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