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CTRI Number  CTRI/2024/07/070169 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluation of acoustic parameters in patients with laryngopharyngeal reflux. 
Scientific Title of Study   Evaluation of Acoustic Parameters in Patients with Laryngopharyngeal Reflux-Interventional 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  Vishnusankar T G 
Designation  Postgraduate 
Affiliation  Srm Medical College Hospital and Research Institute  
Address  Department of Otorhinolaryngology SRMMCH and RC SRM Nagar Potheri Kaatankulathur Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9524262497  
Fax    
Email  tgvishnu96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Balaji CRK 
Designation  Professor 
Affiliation  SRMMCH and RC Kaatankulathur campus 
Address  Department of Otorhinolaryngology SRMMCH and RC SRM Nagar Potheri Kaatankulathur Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884187257  
Fax    
Email  crk_balaji@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vishnusankar T G 
Designation  Postgraduate 
Affiliation  SRMMCH and RC Kaatankulathur campus 
Address  Department of Otorhinolaryngology SRMMCH and RC SRM Nagar Potheri Kaatankulathur Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  09524262497  
Fax    
Email  tgvishnu96@gmail.com  
 
Source of Monetary or Material Support  
Department of otorhinolaryngology SRM nagar Potheri Kaatankulathur Kancheepuram district Tamilnadu 603203 
 
Primary Sponsor  
Name  SRMMCH and RC Kaatankulathur campus 
Address  Department of otorhinolaryngology SRM nagar Potheri Kaatankulathur Kancheepuram district Tamilnadu 603203 
Type of Sponsor  Research institution and hospital 
 
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 Vishnusankar T G  SRMMCH and RC Kaatankulathur campus  Department of otorhinolaryngology SRM nagar Potheri Kaatankulathur Kancheepuram district Tamilnadu 603203
Kancheepuram
TAMIL NADU 		 9524262497

tgvishnu96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J06||Acute upper respiratory infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Esomeprazole   Esomeprazole 40 mg BD Per oral for 3 months  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patients who came with the laryngopharyngeal reflux symptoms are assessed using reflux symptom index were included in the study.reflux symptom index greater than or equal to 13 were taken into study 
 
ExclusionCriteria 
Details  professional voice users,history of voice abuse,past laryngopharyngeal injuries/uncontrolled endocrine or metabolic problems and biological and neurological diseases affecting the larynx,laryngopharynx or oesophagus. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Acoustic voice analysis helps To compare findings in laryngopharyngeal reflux patients before and after antireflux treatment and to prevent laryngopharyngeal reflux complications.  outcome will be assessed at zero,first month and third month. 
 
Secondary Outcome  
Outcome  TimePoints 
To reduce voice disorders in laryngopharyngeal reflux patients.  outcome will be assessed at zero first third month 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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   Phase 4 
Date of First Enrollment (India)   15/07/2024 
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   After obtaining institutional scientific committee and ethical committee clearance,CTRI registration, informed consent written in their own language will be obtained from all the patients.
Patients found eligible as per inclusion criteria were offered to participate in the study.
A proforma was filled for each patient to record.patients who comply with inclusion and exclusion criteria were included in this study.
Patients who came with the LPR symptoms are assessed using reflux symptom index were included in the study.Reflux symptom index greater than or equal to 13 were taken into study.Each patient is evaluated using acoustic voice analysis done at zero,one and third month.The following voice characteristics will be measured in acoustic voice analysis such as average fundamental frequency,highest fundamental frequency,jitter,shimmer,APQ%,jitter%,PPQ%,Harmonic to noise ratio(HNR),Noise to harmonic ratio(NHR). 
 
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