| 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
|
|
|
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
|
|
|
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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