| CTRI Number |
CTRI/2026/01/101999 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Clinical Study to see the Impact of MA2/24 and Caffeine vs. Placebo on Mental and Physical Stamina |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-blind, Cross-Over, Placebo-controlled Study
to Evaluate the Impact of MA2/24 and Caffeine (Alone or in Combination) vs.
Placebo on Mental and Physical Stamina |
| 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 Arun Kumar Rawal |
| Designation |
Musculoskeletal and Sports Physiotherapist |
| Affiliation |
Prehab Musculoskeletal and Sports Health Clinics |
| Address |
Room No. 01, Ground Floor, Mahakavi Kuvempu Metro Station, 2934, Triveni Arcade, Second Floor, 2nd Stage, D Block Mahakavi Kuvempu Road, Landmark: Rajajinagar
Bangalore
KARNATAKA
560010
India |
| Phone |
998685565 |
| Fax |
|
| Email |
drarunkumarrawal.ct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| 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 |
Managing Director and CEO |
| 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 |
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjusha I B |
BGS Global Institute of Medical Sciences |
Research Ward, 5th Floor, Hospital, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9741073960
dranjusha.research@gmail.com |
| Dr Arun Kumar Rawal |
Prehab Musculoskeletal and Sports Health Clinics |
Room No. 01, Ground Floor, Mahakavi Kuvempu Metro Station, 2934, Triveni Arcade, Second Floor, 2nd Stage, D Block Mahakavi Kuvempu Road, Landmark: Rajajinagar
Bangalore
KARNATAKA |
998685565
drarunkumarrawal.ct@gmail.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal hematological and biochemical parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caffeine |
One sachet in 200ml water once
in a day for 7 days
|
| Intervention |
MA2/24 |
One sachet in 200ml water once
in a day for 7 days
|
| Intervention |
MA2/24 + Caffeine |
One sachet in 200ml water once
in a day for 7 days
|
| Comparator Agent |
Placebo |
One sachet in 200ml water once
in a day for 7 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy adults who consume less than 200 mg caffeine per day 2.Employed or performing regular daytime work greater than or equal to 5days per week and greater than or equal to 8hours per day 3.Self-report of feeling tired by the evening on most working days (greater than or equal to 4days per week) confirmed by screening questions and by validated Fatigue Severity Scale (FSS) and ESS. 4.Willing and able to attend clinic visits in the assessment window. 5.BMI 18.5–30 kg per meter square. 6.Willingness to refrain from medications, alcohol or supplements 12 hours prior to testing. 7.Ability to provide informed consent and comply with all study requirements.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women 2.Individuals with cardiovascular disease, hypertension, metabolic disorders, current diagnosis of major psychiatric disorder or cognitive disorder, chronic fatigue syndrome or post-viral fatigue diagnosis 3.Individuals with hearing or visual impairment, sleep disorders, or shift workers 4.Individuals with excessive daytime sleepiness 5.Hypersensitivity to study products 6.Chronic caffeine consumers exceeding 400 mg per day 7.Use of medications and supplements that could affect cognitive or physical performance 8.Chronic medical conditions or lifestyle factors that may affect outcomes. 9.Participation in another clinical trial within the past 30 days. 10.Prior experience or familiarity with the assessment tool.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of MA2/24 supplementation on physical and mental stamina, endurance and
cognitive functions |
Baseline and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of MA2/24 in fatigue, daytime sleepiness |
Baseline and Day 7 |
| Overall safety |
Baseline and EOS |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
05/02/2026 |
| 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) |
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, cross-over clinicalinterventional study. Adult healthy males and/or females, aged between 18and 40 years old and meeting all inclusion and no exclusion criteria will beenrolled in the study after signing a written informed consent. After the informedconsent process, demographic details such as date of birth, sex, ethnicity andrace will be obtained. Medical history including hypertension, diabetes mellitus,chronic liver, gastrointestinal and renal disorders, surgeries, any other clinicallysignificant medical and medication history including dementia will be obtained.Subjects found eligible for study participation will be randomized into one of the4 treatment arms (1:1:1:1) as per randomization schedule for a treatmentperiod of 7 days. The study will be conducted over 9 visits including the entirestudy period and tests for parameters will be performed. |