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CTRI Number  CTRI/2025/01/079046 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on the Safety and Effectiveness of BG-25 for Improving Cognitive Function and Performance in Academic and Professional Settings 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of BG-25 on Cognitive Functions - Implications for Academic and Professional Performance 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-AK-158, Version 1.0 dated 15 Nov 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith C S 
Designation  Assistant Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  OPD No.3, Ground Floor, Department of General Medicine,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9741073960  
Fax    
Email  drharshithcs.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar


KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Akay Natural Ingredients Pvt. Ltd. Malaidamthuruthu P. O Ernakulam, Cochin 683561 Kerala, India  
 
Primary Sponsor  
Name  Akay Natural Ingredients Pvt. Ltd.  
Address  Malaidamthuruthu P. O Ernakulam, Cochin 683561 Kerala, India 
Type of Sponsor  Other [Manufacturer of natural plant based Food ingredients and Nutraceutical ingredients] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshith C S  BGS Global Institute of Medical Sciences  Room No.30, Ground Floor, OPD No.3, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9741073960

drharshithcs.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  With Normal Hematological and Biochemical Parameters 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BG-25  300 mg capsule once a day for 56 days 
Comparator Agent  Placebo  300 mg capsule once a day for 56 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male and female subjects who are students or working-class professionals 2.Subjects with BMI of 18.5 kg per meter square to 29.9 kg per meter square 3.Subjects with Mini-Mental State Examination (MMSE) score greater than 24 and Hamilton Rating Scale for Depression (HAM-D) score less than 7 4.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period 5.Subjects willing to refrain from taking any medications or preparations to improve fatigue during the study 6.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days 7.Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.Subjects willing to refrain from vigorous physical activity 12 hours prior to visit days.9.Females of childbearing age, agree to use approved birth control methods during the study, and have negative UPT at screening 10.Subjects fluent in English language 11.Subjects with basic computer literacy and exposure to computerized tests.12.Subjects willing and able to give informed consent and comply with the study procedures.13.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.

 
 
ExclusionCriteria 
Details  1.Subjects who are on consumption of any cognition, energy and mood improving medicines, alcohol, tobacco, or any other Central Nervous System (CNS) acting medicines.2.Subjects having hypersensitivity or history of allergy to the study product.3.Subjects with moderate to severe fatigue or having chronic fatigue syndrome.4.Subjects with a malignant disease or any concomitant end-state organ disease and or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection5.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease or from a disease found to be inconsistent with the conduct of the study by the investigator.6.Subjects with a psychiatric diagnosis other than anxiety or depression.7.Subjects with sleep disturbances and/or are taking sleep aid medication.8.Subjects with uncontrolled hypertension at screening.9.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications.10.Subjects with a history of drug and or alcohol abuse at the time of enrolment.11.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.12.Subjects with positive UPT at Screening or Randomization Visit.13.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
14.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effects of BG-25, as compared to placebo, on memory,learning and cognitive performance.   Baseline,Day 14, Day 28, Day 56, Day 84  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effects of BG-25, as compared to placebo, on mindfulness.   Baseline, Day 56, Day 84  
To evaluate the effects of BG-25, as compared to placebo, on biomarkers.  Baseline and Day 56 
Overall Safety  Baseline and Day 56 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/01/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a randomized, double-blind, placebo-controlled, parallel group, clinical interventional study. Adult healthy males and/or females, students, working professionals, meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. After the informed consent process, demographic details will be obtained. Eligible subjects will be randomized into one of the treatment arms (1:1) as per randomization schedule for a treatment period of 56 days (8 weeks) and post-treatment follow-up period of 28 days (total of 12 weeks). Efficacy assessments will include all the measures required for the primary objective and secondary objectives of the study.  A subject diary shall be provided to the subjects to record the study product administration, AEs and concomitant medications details during the study duration. Any additional and missed administrations should also be noted in the subject diary. Subject diary shall be used to evaluate study product administration compliance. 
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