| CTRI Number |
CTRI/2024/03/064278 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
N Acetyl Cysteine in the management of Zinc Phosphide Poisoning |
|
Scientific Title of Study
|
Efficacy of N Acetyl Cysteine in the management of Zinc Phosphide Rodenticide Poisoning and its outcomes: A Randomized Double Blinded Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siva K V |
| Designation |
Resident Doctor |
| Affiliation |
J.L.N Medical College Ajmer |
| Address |
Department of Emergency Medicine
J.L.N Medical College and Hospital
Ajmer
RAJASTHAN
305001
India |
| Phone |
8667530385 |
| Fax |
|
| Email |
sivakvelmurugan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharad Jain |
| Designation |
Associate Professor |
| Affiliation |
J.L.N Medical College Ajmer |
| Address |
Department of Emergency Medicine
J.L.N. Medical College and Hospital
Ajmer
RAJASTHAN
305001
India |
| Phone |
9829680727 |
| Fax |
|
| Email |
drsharadjain20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siva K V |
| Designation |
Resident Doctor |
| Affiliation |
J.L.N Medical College |
| Address |
Department of Emergency Medicine
J.L.N Medical College and Hospital
Ajmer
RAJASTHAN
305001
India |
| Phone |
8667530385 |
| Fax |
|
| Email |
sivakvelmurugan@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.L.N Medical College and Hospital,Ajmer, Rajasthan, India 305001 |
|
|
Primary Sponsor
|
| Name |
J.L.N Medical College and Hospital |
| Address |
J.L.N Medical College and Hospital Ajmer Rajasthan India 305001 |
| Type of Sponsor |
Government 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 |
| Dr Siva K V |
J.L.N Medical College and Hospital |
Emergency Medicine ward/Causality ward/room no:111
Department of Emergency Medicine
J.L.N Medical College and Hospital Ajmer
Ajmer
RAJASTHAN |
8667530385
sivakvelmurugan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee J.L.N. Medical College Ajmer |
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 |
Injection N Acetyl Cysteine |
N Acetyl cysteine
(150mg/kg in 200ml of 5 % dextrose over 15 min then 50mg/kg in 500 ml of
5% dextrose over 4 hours then 100mg/kg of 1L of 5 % dextrose over 16 hours) |
| Comparator Agent |
Standard treatment |
IV fluids, Inj Mgso4 ,Inj Vit K |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients with history of rodenticide poisoning with zinc phosphide in Emergency OPD
Patient willing for study |
|
| ExclusionCriteria |
| Details |
Patient not willing for study
Poisoning with unknown compound
Patient less than 18 years of age and more than 70 years
If zinc phosphide mixed with other poisons but not limited to alcohol
Patient has preexisting liver pathology which includes acute/chronic hepatitis before ingestion.
Patient has preexisting renal pathology which includes acute chronic renal failure before ingestion.
History of psychiatric illness
History of respiratory or cardiac diseases
History of epilepsy or bleeding tendencies
Treatment initiated before arriving to the emergency OPD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of N acetyl cysteine in management of zinc phosphide rodenticide poisoning in reducing morbidity and mortality in patients |
zero hrs at time of admission
12hrs
24hrs
48hrs
72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess biochemical outcomes
Cardiac outcome with serial ECG studies
To compare morbidity and mortality outcomes |
0hrs
12hrs
24hrs
48hrs
72hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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)
|
Not Applicable |
| 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
|
In this study, we will compare clinical profile and biochemical outcomes in the patients of acute zinc phosphide poisoning management by using Inj N Acetyl Cysteine as an adjuvant at the emergency medicine department inorder to reduce/prevent the morbidity and mortality of the patients through regular monitoring. |