| CTRI Number |
CTRI/2024/09/073915 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study various demographic and risk factors leading to deliberate poisoning in paediatric age group 5-18 years at Indira Gandhi Medical College Hospital Shimla |
|
Scientific Title of Study
|
Epidemiological profile and triggering factors for deliberate poisoning in the age group 5-18 years at Indira Gandhi Medical College Hospital Shimla |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Negi |
| Designation |
Junior resident |
| Affiliation |
Department of Pediatrics IGMC Shimla |
| Address |
Dept of Paediatrics, Indira Gandhi Medical College Hospital Shimla himachal pradesh 171001
India
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7807084630 |
| Fax |
|
| Email |
mamtanegi902@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pancham |
| Designation |
Associate Professor |
| Affiliation |
IGMC shimla |
| Address |
Dept of Paediatrics, Indira Gandhi Medical College Hospital Shimla Ridge sanjauli road lakkar Bazar Shimla Himachal Pradesh 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018810289 |
| Fax |
|
| Email |
Panchamdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pancham |
| Designation |
Associate Professor |
| Affiliation |
IGMC shimla |
| Address |
Dept of Paediatrics, Indira Gandhi Medical College Hospital Shimla Ridge sanjauli road lakkar Bazar Shimla Himachal Pradesh 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018810289 |
| Fax |
|
| Email |
Panchamdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College , Shimla ,Himachal Pradesh, India 171001
and Hospital |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College, Shimla,171001 |
| Address |
Ridge sanjauli road, lakkar Bazar, Shimla, Himachal pradesh 171001 |
| 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 Mamta Negi |
Indira Gandhi Medical College and Hospital ,Shimla |
4th Floor , Block A Department of Paediatrics, Ridge Sanjauli Road, Lakkar Bazar 171001 Shimla Himachal Pradesh .
Kinnaur
HIMACHAL PRADESH |
7807084630
mamtanegi902@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional Ethics committee IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children between age 5-18 years who come with poisoning. |
|
| ExclusionCriteria |
| Details |
Patients whose parents or guardians do not give consent.
Age >18 yrs are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the epidemiological profile of children aged 5-18 years with deliberate poisoning.
2.To study the triggering factors responsible for deliberate poisoning. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for modifiable triggering factors in voluntary poisoning in age group 5-18 years |
6 months |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
25/09/2024 |
| 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 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
|
Deliberate poisoning has become very common in paediatric age group and very less data is available regarding this issue therefore this study will help to know about epidemiological profile and triggering factors for deliberate poisoning. |