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Clinical Trials/CTRI/2020/02/023297
CTRI/2020/02/023297CompletedPhase 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 site in 1 country30 target enrollmentStarted: February 17, 2020Last updated:
Conditions

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)

Investigators

Sponsor
Botanic Healthcare Pvt Ltd
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (1)

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