| CTRI Number |
CTRI/2024/04/066486 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Clinical profile & treatment outcome in patients of snakebite : A prospective observational study at Sir Takhtsinhji Hospital, Bhavnagar |
|
Scientific Title of Study
|
Clinical profile & outcome in snakebite patients : A prospective observational study at a tertiary care hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharmin Trivedi |
| Designation |
Resident doctor |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Room no.112, Intern hostel, Department of General Medicine, Sir Takhtsinhji Hospital, Bhavnagar
Bhavnagar
GUJARAT
364002
India |
| Phone |
9913061639 |
| Fax |
|
| Email |
dstrivedi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Krishna Lakhani |
| Designation |
Head of the department |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Department of General Medicine, Sir Takhtsinhji Hospital, Bhavnagar
Bhavnagar
GUJARAT
364002
India |
| Phone |
9429707472 |
| Fax |
|
| Email |
lakhanikrishna@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Dharmin Trivedi |
| Designation |
Resident doctor |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Room no.112, Intern hostel, Department of General Medicine, Sir Takhtsinhji Hospital, Bhavnagar
Bhavnagar
GUJARAT
364002
India |
| Phone |
9913061639 |
| Fax |
|
| Email |
dstrivedi22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and Sir Takhtsinhji hospital,
Bhavnagar, Gujarat, India
Pin code - 364002 |
|
|
Primary Sponsor
|
| Name |
Dharmin Trivedi |
| Address |
Room no.112, Intern hostel,Department of General Medicine, Sir Takhtsinhji Hospital, Bhavnagar, Gujarat, India
Pin code 364002 |
| 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 |
| Dharmin Trivedi |
Sir Takhtsinhji Hospital |
Room no.112, Intern hostel,Department of General Medicine,Bhavnagar, Gujarat,India. Pin code 364002
Bhavnagar
GUJARAT |
9913061639
dstrivedi22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T630||Toxic effect of snake venom, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Patients admitted with an alleged history of snake bite and clinical presentation and who have given consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Patient who is a known case of coagulopathy.
Patients on anti-coagulants, anti-platelets.
Patients with a history of renal disease.
Patients with a history of neurological disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analysis of clinical profile including demographic factors like age, gender, residence, ecological factors like snake type, site of bite, snake species, clinical features like signs of local envenomation, hemotoxic and neurotoxic bite features, investigations like serum creatinine and WBCT prolongation, treatment factors like total number of ASV given, patients requiring ventilatory support and dialysis in patients with snakebite. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the factors associated with treatment success and failure in patients with snakebite. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/05/2024 |
| 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="0"
Months="9"
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
|
There is a paucity of data regarding snakebite incidents and their outcomes in Gujarat. My study will try to fulfil this gap. This is a prospective observational study titled Clinical profile & outcome in snakebite patients : A prospective observational study at a tertiary care hospital. My aim is to evaluate the clinical profile and outcome in snakebite patients admitted to Sir Takhtsinhji Hospital, Bhavnagar during the study duration of 9 months. I will analyse clinical profile (demographic factors, ecological factors, environmental factors, clinical features, investigations, treatment factors) and outcome of these patients. |