| CTRI Number |
CTRI/2025/10/096634 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
26/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relation between reflux indexes and change in voice score in patients of acid reflux before and after treatment |
|
Scientific Title of Study
|
Correlation between Reflux Symptom Index, Reflux Finding Score and Voice Handicap Index-10 in patients of Laryngopharyngeal Reflux before and after treatment |
| 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 Neha Agarwal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of ENT Varun Arjun Medical College and Rohilkhand Hospital, Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9001016513 |
| Fax |
|
| Email |
agneha511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poornima S Bhat |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of ENT Varun Arjun Medical College and Rohilkhand Hospital, Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7867834401 |
| Fax |
|
| Email |
Poornimasbhat86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saquib R Khan |
| Designation |
Associate Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of ENT Varun Arjun Medical College and Rohilkhand Hospital, Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7275710184 |
| Fax |
|
| Email |
Saquibkhan366@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital, Lucknow road, Banthra, Shahjahanpur |
|
|
Primary Sponsor
|
| Name |
Dr Neha Agarwal |
| Address |
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, India, 242307 |
| 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 |
| Dr Neha Agarwal |
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur |
Department of ENT Varun Arjun Medical College and Rohilkhand
Hospital, Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH |
9001016513
agneha511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with throat symptoms willing for throat endoscopy and follow up
Patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Patients with history of previous gastric surgery, pregnancy, asthma or COPD or TB, Cerebrovascular accident, hypertension on calcium channel blockers, hypothyroidism, smokers or alcoholics
Vocal cord polyp, nodule or growth
Acute or chronic respiratory tract infections
Patients with previous radiotherapy or head and neck surgeries or neck trauma
Patients already on treatment for LPR/GERD/APD |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation between Reflux Finding Score, Reflux Symptom Index and Voice Handicap Index-10 |
Once at the time of visit
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in clinical scores following six weeks of treatment |
Once after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
06/11/2025 |
| 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="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
|
The study titled “Correlation between Reflux Symptom Index, Reflux Finding Score and Voice Handicap Index in Patients of Laryngopharyngeal Reflux Before and After Treatment” aims to evaluate and correlate clinical scoring systems—RSI, RFS, and VHI-10—for diagnosing and monitoring laryngopharyngeal reflux (LPR). LPR is characterized by the backward flow of gastric contents into the laryngopharynx, leading to symptoms such as hoarseness, chronic cough, throat clearing, and globus sensation. Many patients with LPR do not experience typical gastroesophageal reflux symptoms, making diagnosis challenging. The study’s primary objective is to determine the prevalence of LPR in patients presenting with throat-related complaints and to assess the correlation between RSI, RFS, and VHI-10 scores before and after treatment. It also aims to evaluate improvement in these scores after 2, 4, and 6 weeks of medical management. Adult patients aged 18–60 years will undergo laryngoscopic examination and complete RSI and VHI-10 questionnaires. Patients with conditions like asthma, smoking history, vocal cord lesions, or systemic diseases are excluded. By using simple, non-invasive scoring systems, the study intends to facilitate easier diagnosis, monitor treatment outcomes, and improve clinical care for patients with LPR. |