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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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. 

 
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