| CTRI Number |
CTRI/2024/02/062616 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Cause of vocal cord paralysis |
|
Scientific Title of Study
|
Clinicopathological analysis of unilateral vocal cord paralysis cross sectional study |
| 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 Raj Narayan Samanta |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of ENT Rohilkhand Medical College hospital , pilibhit bypass road, bareilly,UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7631460446 |
| Fax |
|
| Email |
rajjsamanta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HARI GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
rohilkhand medical college and hospital |
| Address |
Department of ENT Rohilkhand medical college and hospital, pilibhit bypass road, bareilly UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837042552 |
| Fax |
|
| Email |
guptadrhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HARI GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital, pilibhit bypass road, bareilly UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837042552 |
| Fax |
|
| Email |
drabhinavsrivastava7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Raj Narayan Samanta |
| Address |
ROHILKHAND MEDICAL COLLEGE BAREILLY |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Raj Narayan Samanta |
Department of ENT Rohilkhand Medical College Bareilly |
Rohilkhand Medical College Bareilly
Bareilly
UTTAR PRADESH |
7631460446
rajjsamanta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,RMCH BAREILLY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R499||Unspecified voice and resonance disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
Patients with change in voice and clinically diagnosed with vocal cord palsy
Patients above 18 years of age
Willing to participate in study |
|
| ExclusionCriteria |
| Details |
Patient unable to understand study termsand unwilling to give written consent
Pediatric population less than 18 years
Post Thyroplasty patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyse the various clinical and pathological findings of unilateral vocal cord palsy
To determine proportion of vocal cord paralysis cases
To document the clinical findings among patients having vocal c ord paralysis
To correlate pathological findings
To study the demographic profile |
at baseline 4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the etiology of vocal cord paralysis |
at baseline 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/02/2024 |
| 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 Applicable |
| 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
|
ï‚· After taking approval from Institutional Ethics Committee, the study will be conducted. ï‚· All the patients of vocal cord palsy, coming in the OPD will be included till thedesired sample size is achieved.Patients will be explained regarding the study and written informed consent will betaken. ï‚· The patient work up will include a detailed history taking, physical and ENT examination . ï‚· Patients will be subjected to Laryngeal endoscopic examination on OPD basis. |