| CTRI Number |
CTRI/2025/10/096397 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring pesticide poison levels in patients using lab tests and to study their relation to illness severity and recovery. |
|
Scientific Title of Study
|
Quantification of Organophosphorus and Paraquat compound using gas chromatography-mass spectrometry in Acute Poisoning Patients and its Correlation with Clinical Severity Scores and Patient Outcomes : A prospective observational study in a tertiary care emergency setting. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitanya CH |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Shambhavi Habitat Apartments, Room 107, perampalli Nekkar Krishnadasa marga, vidyaratna nagar, Manipal .
Udupi
KARNATAKA
576104
India |
| Phone |
7795907034 |
| Fax |
|
| Email |
chaitanya.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sachin Nayak Sujir |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of emergency medicine, kasturba medical college, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449111397 |
| Fax |
|
| Email |
sachin.sujir@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chaitanya CH |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Shambhavi Habitat Apartments, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7795907034 |
| Fax |
|
| Email |
chaitanya.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Udupi district, Karnataka state, India,
576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Kasturba Medical College, Manipal, 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chaitanya Chandragiri |
Kasturba Medical College |
Kasturba Medical Hospital, Manipal, 576104
Udupi
KARNATAKA |
7795907034
chaitanya.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adults above 18 years
All patients with Clinical diagnosis of acute Organophosphorus (Chlorpyrifos) or Paraquat poisoning
Presentation within 48 hours post-exposure
|
|
| ExclusionCriteria |
| Details |
Mixed or multiple substance ingestion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Quantification of organophosphorus compound using GC-MS
2. Clinical severity in OP poison patients (POP score)
3. Clinical severity scoring for Paraquat poison (SIPP,serum paraquat, APACHE
And Mortality |
1. At admission
2. At admission
3. At 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mortality in Organophosphorus poisoning
2. Morbidity indicator (vasopressor-free days, fewer ventilator-free days, or prolonged ICU stay) in paraquat poisoning patients
|
1. 28 days
2. At discharge
|
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="2"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title : Quantification of Organophosphorus(Chlorpyrifos) and paraquat compounds using Gas chromatography-mass spectrometry in acute poisoning patients and its correlation with clinical severity and patient outcomes.Background: Acute pesticide poisoning is a leading cause of morbidity and mortality in India, particularly chlorpyrifos and paraquat herbicide. Clinical tools are widely used but have significant limitations as they rely on markers or clinical estimation rather than direct toxin burden. This study aims to evaluate whether GC-MS based quantification of OP and Paraquat levels correlate better with severity and clinical outcomes.
Study Summary: This is a prospective observational study to be conducted at Kasturba Medical Hospital, Manipal over a period of 2 years and 4 months. A total of 50 Chlorpyrifos OP poisoning and 25 paraquat poisoning will be enrolled, with using blood samples collected within six hours of admission with a informed consent in the patient’s own language. The collected sample will be transported to the biochemical lab under cold chain and stored in -80C. Quantified levels using GC-MS will be correlated with standard severity scores, biochemical markers and patient outcomes including 28 day mortality and morbidity will be recorded using hospital records and telephonic follow-up.
|