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CTRI Number  CTRI/2025/04/084768 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 05/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [caffeine]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effects of caffeine and a glucose-caffeine combination on psychomotor performance  
Scientific Title of Study   To study the effects of caffeine and a glucose-caffeine combination on psychomotor performance among students and staffs of Government Medical College and Research Institute in Bangalore.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Revathi  
Designation  Postgraduate, Department of Pharmacology 
Affiliation  Shri Atal Bihari Vajpayee Medical College and Research Institute 
Address  1 Shri Atal Bihari Vajpayee Medical College and Research Institute, Lady Curzon Road, Shivajinagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560001
India 
Phone  09972797838  
Fax    
Email  drrevathi.raghavan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nalini GK 
Designation  Professor and Head, Department of Pharmacology 
Affiliation  Shri Atal Bihari Vajpayee Medical College and Research Institute 
Address  1 Shri Atal Bihari Vajpayee Medical College and Research Institute, Lady Curzon Road, Shivajinagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560001
India 
Phone  09343610550  
Fax    
Email  nskargk97@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nalini GK 
Designation  Professor and Head, Department of Pharmacology 
Affiliation  Shri Atal Bihari Vajpayee Medical College and Research Institute 
Address  1 Shri Atal Bihari Vajpayee Medical College and Research Institute, Lady Curzon Road, Shivajinagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560001
India 
Phone  09343610550  
Fax    
Email  nskargk97@gmail.com  
 
Source of Monetary or Material Support  
Shri Atal Bihari Vajpayee Medical College and Research Institute,1, Lady Curzon Road, Shivajinagar, Bengaluru, Karnataka 560001 
 
Primary Sponsor  
Name  Dr Revathi 
Address  1 shri Atal Bihari Vajpayee medical college and research institute, lady Curzon Road, Shivaji Nagar, Bengaluru, Karnataka 560001 
Type of Sponsor  Other [Principal investigator] 
 
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 Revathi   Shri Atal Bihari Vajpayee Medical College and Research Institute  1 Shri Atal Bihari Vajpayee Medical College and Research Institute,9th floor, Department of Pharmacology, Lady Curzon Road, Shivajinagar, Bengaluru, Karnataka 560001
Bangalore
KARNATAKA 		 09972797838

drrevathi.raghavan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  -hematological and biochemical parameters are within normal limits. -Age group between 18-40years.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CAFFEINE  coffee brand is Bru Instant Coffee which contains 60mg of caffeine per 5g of coffee 10gms of coffee, STAT DOSE 
Intervention  CAFFIENE WITH GLUCOSE  coffee brand is Bru Instant Coffee which contains 60mg of caffeine per 5g of coffee and the glucose used will be Table Sugar of the Brand Parry’s White Label, which contains 5gms of glucose per 10gms of sugar. 10gms of coffee with 10gms sugar in 125ml of water, STAT DOSE  
Comparator Agent  WATER  125ml of water, STAT DOSE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  -Students and staffs whose hematological and biochemical parameters are within normal limits.
-Students and staffs age group between 18-40years.
 
 
ExclusionCriteria 
Details  -Smoker
-Students and staffs on oral contraceptives.
-Students and staffs with history of caffeine allergy.
-Students and staffs with severe anxiety, cardiovascular diseases or symptomatic cardiac arrhythmias.
-Students and staffs with peptic ulcer disease or gastroesophageal reflex disease.
-Students and staffs who are pregnant.
-Students and staffs with chronic diseases.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in psychomotor performance after administration of:

1)Caffeine alone
2)Glucose-caffeine combination
3)Placebo (water)

This will be assessed using:

1)DLST (Digit Letter Substitution Task)
2)SLCT (Six Letter Cancellation Test)
3)Card Sorting Test
4)Purdue Pegboard Test (PPT) 		 Baseline (pre-administration)
30 minutes post-administration
45 minutes post-administration 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in VAS scores (alertness, calmness, drowsiness) and vital parameters (blood pressure, pulse rate) at 30 and 45 minutes post-intervention.
 		 Baseline (pre-administration)
30 minutes post-administration
45 minutes post-administration 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 
Date of First Enrollment (India)   02/05/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drrevathi.raghavan@gmail.com].

  6. For how long will this data be available start date provided 02-05-2024 and end date provided 31-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This randomized controlled trial aims to evaluate the effects of caffeine and a glucose-caffeine combination on psychomotor performance among healthy students and staff of a medical college. Participants will be randomized into three groups—caffeine, glucose-caffeine, and placebo—and assessed using standardized tests including DLST, SLCT, Card Sorting, and the Purdue Pegboard Test. The primary outcome is the change in psychomotor performance scores at 30 and 45 minutes post-intervention compared to baseline. Secondary outcomes include changes in subjective alertness measured by Visual Analogue Scale (VAS) and variations in vital parameters such as blood pressure and pulse rate.

 
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