| CTRI Number |
CTRI/2025/07/090565 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the Impact of Omega-3 and Brahmi on Brain Performance in Young People |
|
Scientific Title of Study
|
Comparative Study of Omega 3 Fatty Acids and Bacopa Monnieri on Cognitive Performance in Young Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Jijo Philip Abraham |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College Akola |
| Address |
Department Library
Department of Pharmacology
2nd Floor
C Building
GMC Akola
Akola
MAHARASHTRA
444001
India |
| Phone |
9903125931 |
| Fax |
|
| Email |
me.jijo4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Reena R Giri |
| Designation |
Associate Professor and HOD |
| Affiliation |
Government Medical College, Akola |
| Address |
HOD Room
Department of Pharmacology
2nd Floor
C Building
GMC Akola
Akola
MAHARASHTRA
444001
India |
| Phone |
7972851835 |
| Fax |
|
| Email |
dr.reenagiri@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Juslin Jacob |
| Designation |
Clinical Psychologist |
| Affiliation |
MPower Minds |
| Address |
Clinical Psychologist and Outreach Associate
Mpower Helpline
Client Care
MPower Mumbai
Akola
MAHARASHTRA
444001
India |
| Phone |
9464187878 |
| Fax |
|
| Email |
j.jacob2330@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Akola
Collector Office Road
Maharashtra 444001
India |
|
|
Primary Sponsor
|
| Name |
Jijo Philip Abraham |
| Address |
Department of Pharmacology
GMC Akola
Collector Office Road
Maharashtra 444001
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jijo Philip Abraham |
Government Medical College |
Department of Pharmacology
2nd Floor
C Building
Akola
MAHARASHTRA |
9903125931
me.jijo4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitive Performance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bacopa Monnieri |
Participants will consume one tablet daily containing 250 mg standardized Bacopa monnieri extract. |
| Intervention |
Omega 3 Fatty Acids |
Participants will consume one soft-gel capsule daily containing 300 mg omega-3 fatty acids (EPA + DHA). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
No history of neurological or psychiatric disorders.
Willingness to adhere to the study protocol. |
|
| ExclusionCriteria |
| Details |
Current use of cognitive enhancers or similar supplements.
Known allergies to omega-3 fatty acids or Bacopa monnieri.
Presence of medical conditions contraindicating supplementation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive performance, measured using the NIMHANS Neuropsychology Battery:
Memory: Verbal & Visual Learning, & Memory.
Mental Speed: Visuomotor coordination, Response speed.
Attention: Sustained & Divided attention.
Executive Functioning: Category, Design & Verbal fluency, Working Memory, Concept formation, Abstract Reasoning. |
Baseline & at end of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Personality traits, assessed using the Personality Inventory for DSM-5 - Short Form (PID-5-SF). |
Baseline & at end of intervention. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Master Chart can be shared.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [me.jijo4u@gmail.com].
- For how long will this data be available start date provided 15-05-2026 and end date provided 15-05-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized, controlled study aims to compare the effects of Omega-3 fatty acids and Bacopa monnieri supplementation on cognitive performance in healthy young adults. Participants will be randomly assigned to receive either Omega-3, Bacopa monnieri, or no supplement for a six month period. Cognitive function will be assessed using standardized neuropsychological tests at baseline and post-intervention time points. The primary objective is to evaluate changes in memory, attention, and overall cognitive performance between the groups. The study seeks to determine the relative efficacy of these two widely used nutraceuticals in enhancing cognitive function in a healthy population. |