| CTRI Number |
CTRI/2025/02/080476 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Rat Poisoning: presenting complaints and What Can Cause Death |
|
Scientific Title of Study
|
Clinical Presentations, Outcomes, and Predictors of Mortality in Rat Poisoning: A Retrospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeffrey Pradeep Raj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Clinical Pharmacology
Department of Pharmacology
Kasturba Medical College Manipal
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7904286189 |
| Fax |
|
| Email |
jeffrey.raj@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeffrey Pradeep Raj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Clinical Pharmacology
Department of Pharmacology
Kasturba Medical College Manipal
Madhav Nagar, Manipal
KARNATAKA
576104
India |
| Phone |
7904286189 |
| Fax |
|
| Email |
jeffrey.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jeffrey Pradeep Raj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Clinical Pharmacology
Department of Pharmacology
Kasturba Medical College Manipal
Madhav Nagar, Manipal
KARNATAKA
576104
India |
| Phone |
7904286189 |
| Fax |
|
| Email |
jeffrey.raj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Madhav Nagar, Manipal, Karnataka 576104 India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Jeffrey Pradeep Raj |
Kasturba Medical College Manipal |
Division of Clinical Pharmacology
Department of Pharmacology
Kasturba Medical College Manipal
Madhav Nagar, Manipal
Udupi
KARNATAKA |
7904286189
jeffrey.raj@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T604||Toxic effect of rodenticides, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NIl |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who were diagnosed with rat poisoning from 01-01-2020 to 31-10-2024 by the treating physician and which is captured by our Hospital Medical records under code T 60.4 – Rodenticide poisoning will be included.
2. Toxicity with rat poison substances - yellow phosphorous, Zinc phosphide and 4-coumarin derivatives will only be included
|
|
| ExclusionCriteria |
| Details |
1. Toxicity with other rodenticides that are not rat poison but used in pest control of other rodents other than rat will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Signs and symptoms at presentation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mortality rates associated with rat poisoning and Predictors of mortality
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 retrospective study, titled "Clinical Presentations, Outcomes, and Predictors of Mortality in Rat Poisoning," aims to analyze medical records from 2020 to 2024 to describe the clinical presentations of rat poisoning and identify factors predicting mortality. Rat poisoning, particularly from toxic agents like yellow phosphorus and paraquat, poses a significant health risk due to its high toxicity, leading to severe complications such as fulminant hepatic failure and multi-organ dysfunction, with mortality rates ranging from 20% to 75%. The study will include patients diagnosed with rat poisoning caused by yellow phosphorus, zinc phosphide, and 4-coumarin derivatives, while excluding other types of rodenticides. Data on demographics, clinical symptoms, laboratory findings, treatments, and outcomes will be extracted from hospital records using a digital data collection tool. Statistical analysis will involve descriptive statistics and logistic regression to identify predictors of mortality. Ethical approval will be sought, with a waiver of informed consent due to the retrospective, anonymized nature of the data. The findings are expected to enhance understanding of clinical patterns, improve risk stratification, and guide more effective management strategies for rat poisoning, particularly in resource-limited settings. |