| CTRI Number |
CTRI/2025/11/097052 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of a bedside diagnostic test from snake bite victims in Tamilnadu. |
|
Scientific Title of Study
|
Identification of components of snake venom and development of a point of care diagnostic test from children and adults with snake envenomation in Tamilnadu. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Nisha |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Child Health and Hospital for Children |
| Address |
Pediatric intensive care unit , E block 1st floor , Institute of Child Health and hospital for children, Tamil salai road, Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9790906493 |
| Fax |
|
| Email |
nishabashyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Nisha |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Child Health and Hospital for Children |
| Address |
Pediatric intensive care unit , E block 1st floor , Institute of Child Health and hospital for children, Tamil salai road, Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9790906493 |
| Fax |
|
| Email |
nishabashyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
V Poovazhagi |
| Designation |
Professor |
| Affiliation |
Institute of Child Health and Hospital for Children |
| Address |
Pediatric intensive care unit , E block 1st floor , Institute of Child Health and hospital for children, Tamil salai road, Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
|
| Fax |
|
| Email |
nishabashyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 R Nisha |
Institute of Child Health and Hospital for Children |
Pediatric intensive care unit , E block 1st floor , Institute of Child Health and hospital for children, Tamil salai road, Egmore , 600008
Chennai
TAMIL NADU |
9790906493
nishabashyam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Madras Medical College |
Approved |
| Madras Medical College |
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 |
Intervention in the second half of the study involves animal study to develop a snake venom diagnostic kit. |
The predominant component of snake venom will be injected to mice at LD50 and after about 21 days, antibodies will be extracted to develop a snake venom diagnostic kit. |
| Comparator Agent |
No comparator |
No comparator as it is a single arm study |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Around 3ml of blood sample will be collected from the victims of snake bite before administration of anti snake venom. |
|
| ExclusionCriteria |
| Details |
Snake bite victims who have been already administered with anti snake venom. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the composition of venom of each species Common in this region. |
12 months and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop a diagnostic test to find out specific snake venom. |
2nd year - Animal experiment for developing antibodies against venom component.
3rd year- Development of a venom diagnostic kit
4th year- kit validation
5th year - Data analysis. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/01/2026 |
| 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="5"
Months="0"
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
|
The study has been selected for grant under ICMR. Approved by institutional ethical committee to proceed. Regulatory approvals are in process for the collection of snake venom from Tamilnadu Forest Department and snake bite victims blood collection. Once regulatory processes are over, research process will begin with the lab support of NIRT, ICMR, Chennai. |