| CTRI Number |
CTRI/2025/08/093237 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Participants will be given either zinc or vitamin c lozenges before taking them into operation theatre and placing device. The main outcome of the study is to see whether post operative sore throat is reduced after the intervention. |
|
Scientific Title of Study
|
Effect of Zinc and Vitamin C lozenges on post operative sore throat in adults following general anaesthesia using Proseal laryngeal mask airway. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashika gupta |
| Designation |
postgraduate resident |
| Affiliation |
maulana azad medical college |
| Address |
Department of anaesthesia BLT Block
Maulana Azad medical college
New Delhi
DELHI
110002
India |
| Phone |
9811326147 |
| Fax |
|
| Email |
yashikagupta8800@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mona Arya |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Anaesthesiology and Intensive Care BL Taneja Block, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
9968604412 |
| Fax |
|
| Email |
monaarya@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju R Bhalotra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Anaesthesiology and Intensive Care BL Taneja Block, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
9968604219 |
| Fax |
|
| Email |
drakgk@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| maulana azad medical college
BLT block department of anaesthesiology 3rd floor Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Department of anaesthesiology BLT block Maulana Azad medical college Delhi-110002 |
| 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 |
| YASHIKA GUPTA |
MAULANA AZAD MEDICAL COLLEGE, Lok Nayak hospital |
Department of anaesthesia BLT BLOCK BAHADUR SHAH ZAFAR MARG, DELHI GATE -110002
Central
DELHI |
9811326147
yashikagupta8800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ZINC ACETATE |
zinc lozenges will be given to patients 30 min prior to proseal placement. after the surgery gets over and proseal is removed, patients will be asked about any sore throat and will be followed up for 24 hours. if any intervention is required to treat sore throat, it will be documented |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Vitamin c |
Vitamin c lozenges will be given to patients 30 min prior to proseal placement. after the surgery gets over and proseal is removed, patients will be asked about any sore throat and will be followed up for 24 hours. if any intervention is required to treat sore throat, it will be documented |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years |
|
| ExclusionCriteria |
| Details |
PREGNANT WOMEN
PATIENTS HAVING PRE OPERATIVE RESPIRATORY INFECTION |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of patients complaining post operative sore throat at 4 hours |
proportion of patients complaining post operative sore throat at 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence & severity of POST Sr 0,2,4,8,12 & 24 hours post operatively. |
0,2,4,8,12 & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
General anaesthesia involves securing airway with either endotracheal tube or supraglottic airway device which may result in local tissue trauma leading to inflamed airways which manifest as post operative sore throat. POST can cause discomfort and pain requiring intervention leading to delayed discharge. Zinc and vitamin c have anti inflammatory effect and has a role in wound healing. There effect on POST following supraglottic device placement has not been studied so we found it worthwhile to compare their effect. |