FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077563 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Treatment and outcome of different poisoning cases in India. 
Scientific Title of Study   A Prospective observational study on the treatment and outcome of different poisoning cases in a tertiary care teaching hospital of Northern India. 
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 Shama Parveen bhat 
Designation  Postgraduate student 
Affiliation  Government medical college, Jammu 
Address  Government medical college, Bakshi nagar, Jammu, J&K

Jammu
JAMMU & KASHMIR
180001
India 
Phone  9419127509  
Fax    
Email  dr.shamaparveen24@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nusrat Kreem Bhat 
Designation  Professor 
Affiliation  Government Medical College, Jammu 
Address  Department of Pharmacology and Therapeutics, Government Medical College, Jammu

Jammu
JAMMU & KASHMIR
180001
India 
Phone  9419268112  
Fax    
Email  nusratkbhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nusrat Kreem Bhat 
Designation  Professor 
Affiliation  Government Medical College, Jammu 
Address  Department of Pharmacology and Therapeutics, Government Medical College, Jammu

Jammu
JAMMU & KASHMIR
180001
India 
Phone  9419268112  
Fax    
Email  nusratkbhat@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College, Bakshi nagar, Jammu, Jammu and Kashmir, 180001 
 
Primary Sponsor  
Name  Government Medical College, Jammu 
Address  Government Medical College, Bakshi nagar, Jammu, Jammu and Kashmir, 180001 
Type of Sponsor  Government medical college 
 
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 Shama Parveen Bhat  Government Medical College, Jammu  Postgraduate Department of Pharmacology and Therapeutics, Government Medical College, Bakshi nagar, Jammu, Jammu and Kashmir, 180001
Jammu
JAMMU & KASHMIR 
9419127509

dr.shamaparveen24@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Medical College, Jammu Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, (2) ICD-10 Condition: T601||Toxic effect of halogenated insecticides, (3) ICD-10 Condition: T602||Toxic effect of other insecticides, (4) ICD-10 Condition: T603||Toxic effect of herbicides and fungicides, (5) ICD-10 Condition: T604||Toxic effect of rodenticides, (6) ICD-10 Condition: T608||Toxic effect of other pesticides, (7) ICD-10 Condition: T659||Toxic effect of unspecified substance, (8) ICD-10 Condition: T630||Toxic effect of snake venom, (9) ICD-10 Condition: T510||Toxic effect of ethanol, (10) ICD-10 Condition: T511||Toxic effect of methanol, (11) ICD-10 Condition: T520||Toxic effects of petroleum products, (12) ICD-10 Condition: T529||Toxic effects of unspecified organic solvent, (13) ICD-10 Condition: T539||Toxic effects of unspecified halogen derivatives of aliphatic and aromatic hydrocarbons, (14) ICD-10 Condition: T540||Toxic effects of phenol and phenolhomologues, (15) ICD-10 Condition: T543||Toxic effects of corrosive alkalisand alkali-like substances, (16) ICD-10 Condition: T541||Toxic effects of other corrosive organic compounds, (17) ICD-10 Condition: T551||Toxic effect of detergents, (18) ICD-10 Condition: T564||Toxic effects of copper and its compounds, (19) ICD-10 Condition: T620||Toxic effect of ingested mushrooms, (20) ICD-10 Condition: T542||Toxic effects of corrosive acids and acid-like substances, (21) ICD-10 Condition: T569||Toxic effects of unspecified metal, (22) ICD-10 Condition: T579||Toxic effect of unspecified inorganic substance, (23) ICD-10 Condition: T589||Toxic effect of carbon monoxide from unspecified source, (24) ICD-10 Condition: T599||Toxic effect of unspecified gases,fumes and vapors, (25) ICD-10 Condition: T619||Toxic effect of unspecified seafood, (26) ICD-10 Condition: T629||Toxic effect of unspecified noxious substance eaten as food, (27) ICD-10 Condition: T639||Toxic effect of contact with unspecified venomous animal, (28) ICD-10 Condition: T651||Toxic effect of strychnine and itssalts, (29) ICD-10 Condition: T659||Toxic effect of unspecified substance,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA:-
-All suspected cases of poisoning of age 18 years or more of both sexes.
-All suspected cases of poisoning including drug overdose and snake bite. 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA:-
- Patients with age less than 18 years.
- Patients who died before clinical evaluation.
- Patients who left against medical advice.
- Patients/ legally authorized representatives not willing to give consent. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
PRIMARY OBJECTIVES:
1. To know socio-demographic related characteristics in poisoning cases.
2. To know the pattern of different poisoning including incidence, nature, severity, cause/reason of poisoning.
3. To know the pharmacological management including antidotes given in various poisoning cases. 
At the day of admission and discharge 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OBJECTIVES:
To determine the final outcome of poisoning including :
a) Improvement
b) Complications/Disability
c) Death 
At the day of admission & discharge 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   10/12/2024 
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  
The present prospective observational study shall be conducted by the Postgraduate department of Pharmacology and Therapeutics in collaboration with the department of Medicine, Government Medical College, Jammu for a period of one year. The study shall be initiated after obtaining necessary approval from Institutional Ethics Committee, Government Medical College, Jammu. A written informed consent shall be obtained from all the patients / legally authorized representatives(in case patient will not be able to consent) after explaining the nature and purpose of the study in a vernacular language. The patients of poisoning reporting to the Emergency in the department of Medicine, Government Medical College, Jammu shall be enrolled in the study only after fulfilling following Inclusion and Exclusion criteria:-
INCLUSION CRITERIA:-
-All suspected cases of poisoning of age 18 years or more of both sexes.
-All suspected cases of poisoning including drug overdose and snake bite.
EXCLUSION CRITERIA:-
-Patients with age less than 18 years.
-Patients who died before clinical evaluation.
-Patients who left against medical advice.
-Patients/ legally authorized representatives not willing to give consent.
All principles and bioethics shall be followed as per Good Clinical Practices prescribed by Academic Clinical Trials and confidentiality shall be maintained in all records. The data collected from the case files of the study patients shall be noted down and tabulated on a structured proforma specially designed for this purpose which shall further be interpreted and evaluated using appropriate Statistical Analysis.
STUDY POPULATION:-
All the patients of poisoning due to toxic chemicals, drug overdose and snake bite reporting to Emergency in the department of Medicine of Government Medical College, Jammu either directly or after referral from peripheral medical facilities fulfilling the inclusion and exclusion criteria shall be the study participants and they shall be followed till discharge or death.
PARAMETERS FOR DATA COLLECTION:-
The data shall be collected from the case files of the study patients which shall include the following parameters:-
1-Data regarding sociodemographic variables of all study patients including age ,sex ,education marital status, geographical region etc.
2-A detailed history about nature of poison, its class, trade and chemical name, route of ingestion and quantity consumed, place of incident, intention and mode of poisoning , circumstantial evidence in form of bottle, container or empty strip of medicines brought by attendants, presenting complaints, first aid/treatment received at primary level, time lag from exposure of poisoning substance to first aid and time lag from first aid to arrival in our hospital, mode of transportation to hospital. Data regarding medicolegal formalities as per institution’s protocols.
3-A detailed general physical examination of the patient including smell of poisoning substance ,temperature, pulse, BP, type of breathing, tachypnoea, dyspnea, pallor, icterus , cyanosis, pupil size, any fasciculations, condition of skin dry/sweating, salivation etc, burns on lips or buccal mucosa. Jugular venous pressure, oxygen saturation, oedema feet etc.
4-Systemic examination of cardiovascular, respiratory and nervous systems.
5-Mental/emotional state of study patient and any comorbid condition if any .
6-Routine investigations including CBC, TLC, DLC, PBF, BT, CT, LFT, RFT, urine routine examination, random blood sugar, X-ray chest, CT and MRI if indicated, Special investigations like ABG,if indicated.
7-Treatment of poisoning patients and therapeutic intervention as per standard protocols including gastric lavage, administration of specific antidotes, antivenom serum etc.
8-Complications or any disability resulting from poisoning or snakebite and their management.
9-Patients undergoing hemodialysis/peritoneal dialysis, ventilatory support and temporary pacing.
10- In hospital outcome that is discharged or died.
11- Total duration of hospital and ICU stay.
STATISTICAL ANALYSIS:
Statistical Analysis of the data will be done using Microsoft Excel software and SPSS version 23.0. Categorical variables will be presented as frequency (n) and percentages(%) and quantitative variables as mean + SD. End point of the study of patients of poisoning will be clinical recovery, disability or death of the patient enrolled in the study.
 
Close