| CTRI Number |
CTRI/2013/08/003886 [Registered on: 08/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/08/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY OF LONG TERM EFFECTS OF SNAKEBITE ENVENOMATION |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY OF MORTALITY AND LONG TERM MORBIDITY IN SNAKEBITE VICTIMS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KUMAR |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
FIRST YEAR POSTGRADUATE RESIDENT
DEPARTMENT OF MEDICINE
FATHER MULLER MEDICAL COLLEGE
Father Muller Road, Kankanady,
Mangalore
Dakshina Kannada KARNATAKA 575 002 India |
| Phone |
8197445189 |
| Fax |
|
| Email |
kumarkenchetty@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR K S BHAT |
| Designation |
PROFESSOR |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
PROFESSOR
DEPARTMENT OF MEDICINE
FATHER MULLER MEDICAL COLLEGE
Father Muller Road, Kankanady,
Mangalore
Dakshina Kannada KARNATAKA 575 002 India |
| Phone |
9845099492 |
| Fax |
|
| Email |
drksbhat@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR KUMAR |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
FIRST YEAR POSTGRADUATE RESIDENT
DEPARTMENT OF MEDICINE
FATHER MULLER MEDICAL COLLEGE
Father Muller Road, Kankanady,
Mangalore
Dakshina Kannada KARNATAKA 575 002 India |
| Phone |
8197445189 |
| Fax |
|
| Email |
kumarkenchetty@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR KUMAR |
| Address |
POST GRADUATE RESIDENT
DEPARTMENT OF MEDICINE
FATHER MULLER MEDICAL COLLEGE
Father Muller Road, Kankanady,
Mangalore - 575 002,Karnataka
INDIA |
| 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 |
| DR KUMAR |
FATHER MULLER MEDICAL COLLEGE |
ROOM NUMBER 27
DEPARTMENT OF MEDICINE
FATHER MULLER MEDICAL COLLEGE
Father Muller Road, Kankanady,
Mangalore - 575 002,Karnataka
INDIA Dakshina Kannada KARNATAKA |
8197445189
kumarkenchetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL EHTICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
snakebite victims, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
snakebite victims with envenomation |
|
| ExclusionCriteria |
| Details |
snakebite victims without envenomation |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| death |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| deformities, functional impairment |
6 month |
|
|
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)
|
20/11/2012 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Snakebite is an
important medical emergency and occupational hazard in the rural tropics
especially India where agriculture is a major source of employment.
India has the highest number of deaths
due to snakebites with 81,000 envenomations and 11,000 deaths every year ;
although the actual incidence may be much higher as many cases go unreported in
villages. Despite the high mortality, snakebite remains a neglected public
health problem.
The case fatality rate in India varies
from 1.7-20%. The wide variation could be due to
non-availability of medical facilities in remote rural areas compelling many
victims to resort to primitive traditional methods of treatment. Quick
recognition and treatment with anti snake venom (ASV) is essential in order to
restore coagulation and reverse other signs of systemic envenomation and thus
avoid severe morbidity and mortality. However a review of current literature
shows a lack of monitoring of morbidity related to snakebite envenomation in
India. This is unfortunate as most of the snakebite victims are in the
economically productive age group and thus the economic impact of the
disability is likely to be high.
The goal in treatment of snakebite
envenomation should be to prevent or reduce all grades of injury, not just
those that are life threatening. The first step in this direction would be to
estimate the morbidity produced by snakebite envenomation so that effective
steps may be taken in the treatment.
Hence the
study aims to determine mortality and long term morbidity in snakebite victims
admitted to Fr Muller Medical College Hospital. |