| CTRI Number |
CTRI/2025/05/087302 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To investigate the clinical characteristics of ear, nose, and throat injuries resulting from motor vehicle collisions. |
|
Scientific Title of Study
|
A study of clinical manifestations of otorhinolaryngological trauma following road traffic accident at a rural tertiary care centre . |
| 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. Jaya Raje Gupta |
| Designation |
Junior Resident |
| Affiliation |
junior resident in department of ENT |
| Address |
Department of ENT , C block ,
Acharya Vinoba Bhave hospital
Sawangi Meghe
Wardha MAHARASHTRA 442107 India |
| Phone |
9457065194 |
| Fax |
|
| Email |
drguptarajejaya3003@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shraddha jain |
| Designation |
Professor in department of ent |
| Affiliation |
Professor in department of ent |
| Address |
department Of Ent , C Block ,
Acharya Vinoba Bhave rural hospital
sawangi (Meghe ) wardha MAHARASHTRA department Of Ent , C Block ,
Acharya Vinoba Bhave rural hospital
sawangi (Meghe ) wardha MAHARASHTRA Wardha MAHARASHTRA 442004 India |
| Phone |
9881836366 |
| Fax |
|
| Email |
sjain_med@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Jaya Raje Gupta |
| Designation |
junior resident in department of ENT |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of ENT , C Block ,
Acharya Vinoba Bhave hospital
Sawangi Meghe Department Of ENT , C Block ,
Acharya Vinoba Bhave hospital
Sawangi (Megh) Wardha MAHARASHTRA 442107 India |
| Phone |
9457065194 |
| Fax |
|
| Email |
drguptarajejaya3003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe institute of higher education and research Sawangi (MEGHE) Wardha , Maharashtra , 442107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe institute of higher education and research |
| Address |
Sawangi (Meghe )Wardha |
| Type of Sponsor |
Private 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 Jaya Raje Gupta |
Acharya Vinoba Bhave Rural Hospital |
C block,ground floor, department of ENT Acharya Vinoba
Bhave Rural Hospital Sawangi Meghe Wardha MAHARASHTRA |
9457065194
drguptarajejaya3003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta meghe institute of higher education and research (deemed to be university)INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S028||Fractures of other specified skulland facial bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all the patients with otorhinolaryngological injuries above 5yrs age presenting within 48 Hours of trauma . |
|
| ExclusionCriteria |
| Details |
children below 5 yrs age
Previous history of road traffic accident
Craniofacial malformation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In this study clinical manifestation of otorhinolaryngological trauma following road traffic accident will be evaluated , examined and statistically analyzed on the basis of literature available in 2 years |
over period of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
01/07/2025 |
| 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="2" 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
|
Road traffic accidents stand as one of the leading causes of mortality and morbidity across the globe. The reasons for the high burden of road traffic injuries (RTAs) in developing countries are increasing in the number of motor vehicles, poor enforcement of traffic safety regulations, inadequacy of health infrastructure and poor transport facility. However, the systematic collection of road traffic data is not well developed in many developing countries including India and under-reporting of RTAs and deaths are common. Hence, surveillance of RTAs is recommended to assess the burden, to identify high-risk groups, to establish an association with probable risk factors and to plan interventions to control the RTAs. A clearly defined road safety policy, a central coordinating agency, allocation of adequate resources, strict implementation of proven and effective interventions and reliable information systems are urgently required. Otorhinolaryngologic trauma is an area of major concern as it is a frequent accompaniment of RTAs and vital sensory end organs are located here. The morbidity, mortality, disability and economic loss occurring because of the road mishap are irreparable. Otorhinolaryngologists play a vital role in the management of the road traffic accidents if timely intervention is given. So this study is being undertaken to study the clinical manifestations of the otorhinolaryngological trauma associated with RTA with its risk factors and outcomes at a rural setting in central India. |