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Herbal formulation clinical trial on Cognitive adult patient

Phase 3
Completed
Conditions
Congenital malformation of brain,unspecified,
Registration Number
CTRI/2020/02/023297
Lead Sponsor
Botanic Healthcare Pvt Ltd
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

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To study the efficacy and safety of Ashwagandha in subjects with cognitive impairmentDay 0 Day 28 and Day 56
Secondary Outcome Measures
NameTimeMethod
1.Adverse events (AEs), frequency and severity.2.Number of subjects who discontinue study due to adverse events

Trial Locations

Locations (1)

Sri venkateshwara Hospitals

🇮🇳

Bangalore, KARNATAKA, India

Sri venkateshwara Hospitals
🇮🇳Bangalore, KARNATAKA, India
DrPoorna prasad
Principal investigator
9481594148
shettyshospital@gmail.com

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