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CTRI Number  CTRI/2024/11/076424 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of ITCs caffeine powder  
Scientific Title of Study   A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of ITCs oral solid dose caffeine granules for the clinical evaluation of its efficacy as an instantaneous stimulant & overall energy and mood booster. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CG/ITD/MF/01/24 Ver 1.0 Dated 26 July 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Poorna Prasad S 
Designation  Principal Investigator 
Affiliation  Sri Venkateshwara Hospital 
Address  Room No,1, Dept. of General Medicine, Sri Venkateshwara Hospital, Sky Heights, Site No.1/2, Sarjapur-Attibele Main Road, Indelbele Village, Bengaluru

Bangalore
KARNATAKA
562107
India 
Phone  9164245208  
Fax    
Email  spoornaprasad123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parag Vilas Naik 
Designation  Principal Technologist 
Affiliation  ITC Limited 
Address  ITC Life Science and Technology Centre, ITC Limited, 1st Phase, Peenya Industrial Area, Peenya, Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  08042787114  
Fax    
Email  parag.naik@itc.in  
 
Details of Contact Person
Public Query
 
Name  Dr Parag Vilas Naik 
Designation  Principal Technologist 
Affiliation  ITC Limited 
Address  ITC Life Science and Technology Centre, ITC Limited, 1st Phase, Peenya Industrial Area, Peenya, Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  08042787114  
Fax    
Email  parag.naik@itc.in  
 
Source of Monetary or Material Support  
ITC Limited 
 
Primary Sponsor  
Name  ITC Limited 
Address  ITC LIFE SCIENCE AND TECHNOLOGY CENTRE ITC Limited, 1st Phase, Peenya Industrial Area, Peenya, Bangalore 560058, Karnataka, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Poorna Prasad S  Sri Venkateshwara Hospital  Room No,1, Dept. of General Medicine, Sri Venkateshwara Hospital, Sky Heights, Site No.1/2, Sarjapur-Attibele Main Road, Indelbele Village, Bengaluru
Bangalore
KARNATAKA 
08022042991

spoornaprasad123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateshwara Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  General Health 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caffeine granules  5g, twice daily, oral , 15 days 
Comparator Agent  Pharmacological Inert powder  5g, twice daily, oral, 15 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Healthy male and female subjects between the age groups of 18–60 years
2.Subjects willing to participate and comply with the protocol procedures by signing an Informed Consent Form to participate in the study.
 
 
ExclusionCriteria 
Details  1.Subjects with the current history of smoking and/or alcohol consumption.
2.Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc.
3.Subjects with a known history of any malignant disease.
4.Subjects with known history of autoimmune disease and other systemic diseases related to immune system.
5.Subjects suffering with any severe infectious or communicable diseases like HIV & HBsAg.
6.Subjects with concomitant treatment with corticosteroids.
7.Subjects who participated in another clinical trial less than 3 months prior to this study.
8.Female subjects, who are pregnant, breast feeding or expecting pregnancy during the study period.
9.Subjects with the history of consumption of any recreational drugs.
10.Subjects who are scheduled for any surgery within 3 months period of completing the study.
11.Subjects who are pre-diabetic/ diabetic or hypertensive or hyperlipidemic
12.Subjects with inability or unwillingness to abide by the requirements of the protocol.
13.Subjects who are incompetent to sign an Informed Consent Form.
14.Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from the baseline to the end of the treatment period in:

o Profile of Mood States (POMS) Scale Score.
 
0 Day, 7th Day, 15th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Change from the baseline to the end of the treatment period in:

o WHO-Quality of Life (WHOQOL-BREF)
o Laboratory Safety Parameters
o Treatment Emergent Adverse events (AEs)-frequency and severity 
0 Day, 15th Day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Caffeine is the most commonly consumed stimulant worldwide and caffeinated beverages, like coffee, have been consumed for centuries. Caffeine has been extensively studied and used to improve cognitive performance, mental alertness, and energy. Caffeine possesses performance enhancing benefits including physical endurance, reduction of fatigue, and enhancing mental alertness and concentration and therefore caffeine is consumed for a variety of reasons.

The current study is planned to assess the effectiveness of caffeine granules towards the management of mood and alertness in general healthy population. A total of 80 Eligible healthy subjects in the age group of 18-60 years of both genders will be randomized into 1:1 and will be assigned to either active caffeine or placebo group of 40 subjects each based on the protocol-defined randomization procedure. The effectiveness of the active caffeine granules will be assessed through psychometric and quality of life questionnaires. The clinical data will be processed for the statistical assessment to check the effectiveness of active caffeine granules over the placebo towards the mental alertness, mood and general well-being of the study participants. The total study duration is 15 days comprising of three clinical visits including two times blood testing at the baseline and at the end of the study. Physical examination and adverse event information will be assessed at each visit.

The effectiveness of the formulation for mood enhancing, anti-stress, alertness and over-all energetic are typically assessed in terms of the management of the parameters of mood profile and quality of life during a suggested period of 2 weeks study. This is the optimal treatment duration to demonstrate the objective of achieving the safety, efficacy and over-all acceptance of formulation for long term consumption.

 
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