A randomized, double-blind, placebo-controlled clinical study to evaluate comparative clinical Efficacy and Safety of BHC9612CP on Cognitive Function in Adult Subjects
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To study the efficacy and safety of Ashwagandha in subjects with cognitive impairment
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 40.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To study the efficacy and safety of Ashwagandha in subjects with cognitive impairment
Time Frame: Day 0 Day 28 and Day 56
Secondary Outcomes
- 1.Adverse events (AEs), frequency and severity.(2.Number of subjects who discontinue study due to adverse events)
