| 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
|
|
|
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
|
|
|
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
|
|
|
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. |