| CTRI Number |
CTRI/2023/07/055826 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Clinical Picture and Result of Facial Nerve Palsy at Tertiary Care Hospital |
|
Scientific Title of Study
|
A Study of Clinical Profile and Outcome of Facial Nerve
Palsy at tertiary Care Hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Birendrakumar Makdia |
| Designation |
1st year resident |
| Affiliation |
Goverment Medical Collage,Bhavnagar |
| Address |
Room no-303 , PG-2 hostel,
Sir T hospital campus,
Jail road ,
Bhavnagar 364001(Gujarat)
Bhavnagar
GUJARAT
364001
India |
| Phone |
8238024725 |
| Fax |
|
| Email |
makadiakrishna42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSushil G Jha |
| Designation |
Head of department |
| Affiliation |
Goverment Medical Collage, Bhavnagar |
| Address |
ENT department,
Sir T hospital, Jail road,Kalanana
Bhavnagar - 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSushil G Jha |
| Designation |
Head of department |
| Affiliation |
Goverment Medical Collage, Bhavnagar |
| Address |
ENT department,
Sir T hospital,Jail road,Kalanana
Bhavnagar - 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology, Government Medical College and SirTakhtsinhji General Hospital, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Otorhinolaryngology and Head and Neck surgery |
| Address |
Sir T Hospital,Goverment Medical Collage, Jail Road,Kalanana, Bhavnagar |
| 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 Krishna Birendrakumar Makadia |
Sir -T Hospital |
Otorhinolaryngology,Sit T hospital
jail road, Kalanana,
Bhavnagar
Bhavnagar
GUJARAT |
8238024725
makadiakrishna42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB GMC Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G518||Other disorders of facial nerve, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients of facial nerve palsy will be included in this study
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate pre and post management grading (HOUSE-BRACKMANN) of facial nerve palsy.
|
To evaluate pre and post management grading (HOUSE-BRACKMANN) of facial nerve palsy at 1st ,3rd and 6th month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate different causes of facial nerve palsy
To evaluate facial nerve palsy in different age & gender
|
To evaluate different causes of facial nerve palsy
To evaluate facial nerve palsy in different age & gender at 1st ,3rd & 6th month
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/08/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My study is observational study. In this study all the patients meeting inclusion criteria wii be selected for study and evaluated based on clinical presentation. Patients who will be participating in the study will be followed up after 1st month, 3rd onth, 6th month and improvement assessed clinically (HOUSE-BRACKMANN GRADING)
|