Effect of Brahmi Ghee on memory in elderly populatio

Phase 2

• Conditions: Health Condition 1: G328- Other specified degenerative disorders of nervous system in diseases classified elsewhere

• Registration Number: CTRI/2019/06/019780
• Lead Sponsor: Foundation for Revitalization of Local Health Traditions

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

i) MCI diagnostic criteria --

a) Change in cognition a concern for participant/informant

b) Objective evidence of impairment

c) Preservation of independence in functional abilities

d) No evidence of dementia

ii) Participants of both the genders above 55 years

iii) Literate population (minimum 7th pass)

iv) Participants on drugs (such as cholinesterase inhibitors) can be included only after a washout period for the drug. Decision to discontinue ongoing medication will be taken by clinicians upon the willingness of the participant.

v) Participants undergoing Cognitive Training/Rehabilitation can be included if their ongoing training has not shown satisfactory improvements in symptoms, as assessed by the clinician,and upon willingness of the participant to discontinue the ongoing training to try an alternative

treatment.

vi) MRI (cortical thickness, temporal lobe atrophy, etc. â?? signs of degeneration)

Exclusion Criteria

i) Dementia

ii) Depressive symptoms (Geriatric depression scale)/ psychiatric illness/ head injury

iii) Alcohol/Drug Dependence

iv) Hearing or visual impairment which can alter cognitive test outcome

v) Uncontrolled diabetes ((HbA1C >7.0)

vi) Hyper-lipidaemia (serum cholesterol >240mgs/dl, serum triglycerides >500, LDL >200)

vii) Hypothyroidism

viii) MRI (evidence of stroke, head injury, lesions)

ix) Medications for MCI including Brahmi in any form

x) Any other ongoing Ayurvedic treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in cognitive functions in Brahmi Ghee group compared to Plain Ghee and Placebo group.Timepoint: Baseline <br/ ><br>1st follow up <br/ ><br>2nd follow up <br/ ><br>post intervention

Secondary Outcome Measures

Name	Time	Method
Improvement in cognitive functions in Brahmi Ghrita group compared to <br/ ><br>Comparative group (Brahmi extract).Timepoint: Baseline <br/ ><br>1st follow up <br/ ><br>2nd follow up <br/ ><br>post intervention