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CTRI Number  CTRI/2026/02/102853 [Registered on: 03/02/2026] Trial Registered Prospectively
Last Modified On: 25/08/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Study to Assess the Safety of Investigational product Youniqor Consumption in Healthy Participants. 
Scientific Title of Study   An Open-label, Single-arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
250901/IP/SS Version 1 Date 24 Dec 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ishan Mishra 
Designation  Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd, 203, Morya Landmark 1, off New Link Road, Andheri West, Mumbai.

Mumbai
MAHARASHTRA
400053
India 
Phone  8655321732  
Fax    
Email  ishan.m@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ishan Mishra 
Designation  Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd, 203, Morya Landmark 1, off New Link Road, Andheri West, Mumbai.

Mumbai
MAHARASHTRA
400053
India 
Phone  8655321732  
Fax    
Email  ishan.m@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Kishori Pashte 
Designation  Assistant Project Lead 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd, 203, Morya Landmark 1, off New Link Road, Andheri West, Mumbai.

Mumbai
MAHARASHTRA
400053
India 
Phone  8291757065  
Fax    
Email  kishori.p@vediclifesciences.com   
 
Source of Monetary or Material Support  
YOXLO B. V. 
 
Primary Sponsor  
Name  YOXLO B. V. 
Address  Haarlemmerstraatweg 31-8535 2343LA Oegstgeest, The Netherlands  
Type of Sponsor  Other [Organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratik Wadhokar  Pawana Hospital  Gat No- 167 Urse, Parandwadi Rd, Somatane Phata, Taluka- Maval, Pune, Maharashtra 410506.
Pune
MAHARASHTRA 		 9860992755

drpratik.pawana@gmail.com 
Dr Kushal Bangar  Shivam Hospital  Plot No.57 G.R.W CHS, Near MIDC Water Tank Kalyan Road, Dombivli East 421201
Thane
MAHARASHTRA 		 9545664884

drkushal.bangar83@gmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Altezza Institutional Ethics Committee  Approved 
The Central Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Safety study in healthy volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Youniqor  Dose: Two sachets (containing 3,600 mg each) per day i.e. 7,200 mg per day Regimen: 1 sachet containing 3,600 mg twice a day to be dissolved in 100 mL water and taken with meals (morning and evening) Route: Oral 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Individuals willing to give written informed consent to participate in the study.
2. Healthy men and women aged 60 to 80 years (both values included).
3. Individuals with Body Mass Index (BMI) 22.5 to 29.9 kg per meter square (both values included).
4. Individuals with hsCRP levels 0.7 to 5.0 mg per Liter (both values included).
5. Individuals willing to avoid specific training and or practice on the muscle and or cognition endpoints during the study.
6. Compliance with the requirements of the entire protocol.
7. Individuals willing to follow all the study procedures and follow-up visits. 
 
ExclusionCriteria 
Details  1. Individuals with chronic/inflammatory or cardiometabolic disease requiring daily medication.
2. Presence of uncontrolled diabetes mellitus (Indicated by fasting blood glucose greater than or equal to 126 mg/dL).
3.Individuals with hypertension.
4. Individuals with eGFR less than 60 mL/min/1.73 m².
5. Individuals with AST/ALT greater than 2× Upper Limit of Normal (ULN).
6. Individuals with WBC count below 3500/mm3.
7. Individuals with any ongoing or history of acute infection within past 2 weeks.
8. Individuals with recent vaccination within past 4 weeks.
9. Individuals having known allergy/intolerance to N-acetyl-L-cysteine (NAC) or glycine.
10. Individuals who have targeted practice on study endpoints.
11. Diagnosed with neurodegenerative, neurological or other major psychiatric disorders.
12. Any other conditions which may, in the Investigator’s opinion, be accompanied by anemia, chronic diseases or anticoagulation therapy.
13. Individuals who are on systemic corticosteroids, immunosuppressants or chronic pain medications.
14. Participation in other clinical trials in last 90 days prior to screening.
15. Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigator’s clinical judgment.
16. Current smokers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety profile of Youniqor by assessing the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs).  Throughout the study 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Youniqor in comparison to baseline on Vitals like Blood pressure, Pulse rate, Peripheral oxygen saturation.  Day 0, Day 28, Day 56 
To assess the effect of Youniqor in comparison to baseline on Hematology: Hb, Hct, RBC, WBC count (total + differential), platelets count.  Day 0, Day 28, Day 56 
To assess the effect of Youniqor in comparison to baseline on
a.Electrolyte: Na+, K+, Cl-
b. Blood urea nitrogen, Creatinine + estimated glomerular filtration rate
c. Fasting Blood Glucose
d. Liver Function Test [Aspartate aminotransferase, Alanine aminotransferase, Gamma-glutamyl transpeptidase, Alkaline phosphatase, Total Bilirubin, Total Proteins
e. Complete Lipid panel for Low-density lipoprotein, High-density lipoprotein, Triglycerides, Total Cholesterol, Very low density lipoprotein  		 Day 0, Day 28, Day 56 
To assess the effect of Youniqor in comparison to baseline on Urine examination   Day 0, Day 28, Day 56 
To assess the effect of Youniqor in comparison to baseline on 12-lead Electrocardiogram  Day 0 and Day 56 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 2 
Date of First Enrollment (India)   15/02/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Aging is associated with a gradual decline in physiological function, accompanied by changes in cellular stress responses, redox balance, and mitochondrial function, which may contribute to increased vulnerability to chronic disease and functional impairment. 

Youniqor is a proprietary nutraceutical formulation containing N-acetyl-L-cysteine (NAC) and glycine. This open-label, single-arm Phase 1 study evaluates the safety and tolerability of daily Youniqor consumption for 8 weeks in healthy adults aged 60–80 years. Safety will be assessed through adverse event monitoring, vital signs, clinical laboratory testing (hematology, renal and liver function, electrolytes, fasting glucose, lipid profile), urinalysis, and 12-lead ECG. Exploratory assessments of muscle, cognitive, and immune function will be performed to inform the design of future XPRIZE Healthspan-aligned studies.

 
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