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CTRI Number  CTRI/2025/02/080585 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety, Efficacy, and Bioavailability of PS2 in Different Doses – A Pilot Study 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Efficacy, and Bioavailability of PS2 in Physical Performance.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-AK-162, Version 1.0 dated 20 Jan 2025  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  Room No.03,Department of General Medicine, Ground Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  8792516793  
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, Kerala 683561, India  
 
Primary Sponsor  
Name  Akay Natural Ingredients Pvt. Ltd 
Address  Malaidamthuruthu P.O Ernakulam, Kerala 683561, 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.03, Department of General Medicine, Ground Floor, no.67, BGS Health and Education City, Uttarahalli Raod, Kengeri
Bangalore
KARNATAKA 		 8792516793

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  Normal hematological and biochemical parameters 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  5g orally once a day for 7 days 
Intervention  PS2  1g orally once a day for 7 days 
Intervention  PS2  3g orally once a day for 7 days 
Intervention  PS2  5g orally once a day for 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.BMI between 18.5 and 29.9 kg/m² 2.Non-smokers and non-alcoholic participants 3.Engaged in moderate physical activity 4.Willing to maintain their habitual diet and exercise routine during the study period 5.Able to provide informed consent and comply with the study protocol.

 
 
ExclusionCriteria 
Details  1.History of cardiovascular, metabolic, renal, or gastrointestinal disorders 2.Use of medications affecting nitric oxide metabolism 3.Recent use of nitrate-rich dietary supplements 4.Regular use of antibacterial mouthwash (as it affects nitrate metabolism) 5.Pregnancy or lactation 6.Allergic to PS2 or any supplement components
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effect of PS2 in Physical Performance   Baseline and Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the bioavailability markers after the acute supplementation of PS2 in different doses   Day 1 
Safety Parameters  Baseline and Day 7 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/02/2025 
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="3"
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 double blind, parallel group, randomized clinical trial. Adult subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into one of the four treatment arms (1:1:1:1) to receive different doses of PS2 or placebo for 7 days. Baseline blood samples will be collected for the laboratory assessments and safety assessments (Visit 1) and will be dispensed a subject diary and IP and will be instructed to return for follow-up visits on Day 1 & Day 7. 
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