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CTRI Number  CTRI/2025/12/098460 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 20/07/2026
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   To understand the adverse effects which is produced by using nutritional supplements 
Scientific Title of Study   Assessing The Safety Of Nutraceuticals Through A Nutrivigilance Approach And To Develop A Surveillance System For Monitoring Adverse Events Associated With Nutraceuticals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
KIEC/ECB/2025/005  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JIJI K 
Designation  PhD Scholar 
Affiliation  Sri Adichunchangiri College of Pharmacy 
Address  Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448
Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448
Mandya
KARNATAKA
571448
India 
Phone  9400466188  
Fax    
Email  jijichithira3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B J Mahendra Kumar 
Designation  Professor and HOD 
Affiliation  Sri Adichunchangiri College of Pharmacy 
Address  Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448
Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448
Mandya
KARNATAKA
571448
India 
Phone  8547803383  
Fax    
Email  bjmahendra2003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B J Mahendra Kumar 
Designation  Professor and HOD 
Affiliation  Sri Adichunchangiri College of Pharmacy 
Address  Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448
Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448
Mandya
KARNATAKA
571448
India 
Phone  8547803383  
Fax    
Email  bjmahendra2003@gmail.com  
 
Source of Monetary or Material Support  
Kauvery hospital, Electronic city, Bangalore 
Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448 
 
Primary Sponsor  
Name  JIJI K 
Address  Sri Adichunchanagiri College of Pharmacy, B G Nagara,Mandya District, Karnataka State, India. Pin code 571448 
Type of Sponsor  Other [Self] 
 
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 Naganand K A  Kauvery Hospital Electronic city Bangalore  #92/1B, Konappana Agrahara, Electronic City Phase-1, Bengaluru, Karnataka 560100
Bangalore
KARNATAKA 
8925509046

ethics.ecb@kauverhospital.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kauvery Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Human healthy volunteers prescribed with nutraceuticals or on self medication with nutraceuticals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Nutraceuticals  Post marketing surveillance study on nutraceuticals. The study will be conducted for a period of 4 years. And once enrolled the patient will be under follow up for 6 months 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Patients of all ages, from paediatric to geriatric populations who are willing to enrol into study after filling the informed consent form, who should be available for revisits and follow-ups of minimum 06 months until reaching the required study endpoints will be enrolled.

2)Patient taking nutraceuticals
 
 
ExclusionCriteria 
Details  1) Patients who have not taken the dietary supplement categorized as nutraceuticals as directed by the manufacturer or healthcare professional.

2) Chronic and severely ill patients.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the safety of commonly used nutraceuticals and to develop a surveillance system for use of nutraceuticals.  4 years 
 
Secondary Outcome  
Outcome  TimePoints 
Number of ADR reported  4 years 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   12/01/2026 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The proposed study introduces a pioneering approach to ensuring the safety of dietary supplements by integrating nutrivigilance principles with cutting-edge surveillance systems. This innovative framework aims to bridge the existing knowledge gap in monitoring adverse events associated with nutraceuticals, thereby enhancing consumer protection and public health through:


1.     Integration of Nutrivigilance and Surveillance: The study combines the principles of nutrivigilance with advanced surveillance systems to create a robust framework for monitoring dietary supplement safety.

2.     Focus on Adverse Event Monitoring: The research prioritizes the development of a surveillance system specifically designed to track adverse events related to nutraceuticals, addressing a critical need in the current regulatory landscape.

3.     Interdisciplinary Approach: The study brings together expertise from nutrition, pharmacovigilance, and public health to create a comprehensive framework for ensuring dietary supplement safety.

4.     Potential for Real-World Impact: The proposed surveillance system has the potential to inform regulatory policies, guide industry practices, and ultimately protect consumers from adverse events associated with dietary supplements.

5.     Development of a Standardized Framework: The research aims to establish a standardized framework for monitoring dietary supplement safety, which can be adopted by regulatory agencies, industry stakeholders, and researchers worldwide.

6.     Potential for Real-World Impact: The proposed surveillance system has the potential to inform regulatory policies, guide industry practices, and ultimately protect consumers from adverse events associated with dietary supplements.

The study employs A mixed-method approach combining quantitative and qualitative methods will be employed. The study will include cross-sectional surveys, real-time adverse event reporting, and stakeholder

interviews to evaluate the implementation and outcomes of the nutrivigilance system.


 
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