| CTRI Number |
CTRI/2025/02/080558 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Control Trial on the effect of aneasthetic betadine gargle for children with acute tonsillitis |
|
Scientific Title of Study
|
Aneasthetic betadine gargle - An advanced antiseptic for children with acute tonsillitis. |
| 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 Akshaya S |
| Designation |
POST GRADUATE |
| Affiliation |
Saveetha medical college |
| Address |
Department of ENT, Saveetha medical college and hospital, Saveetha nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7358159920 |
| Fax |
|
| Email |
akshaya1308@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Manoj Kumar L |
| Designation |
Professor |
| Affiliation |
Saveetha medical college |
| Address |
Department of ENT, Saveetha medical college and hospital, Saveetha nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9940220098 |
| Fax |
|
| Email |
dr.manojkumar247@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Akshaya S |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college |
| Address |
Department of ENT, Saveetha medical college and hospital, Saveetha nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7358159920 |
| Fax |
|
| Email |
akshaya1308@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAVEETHA MEDICAL COLLEGE HOSPITAL,SAVEETHA NAGAR, THANDALAM, CHENNAI - 602105, TAMILNADU, INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Akshaya S |
Room no 301, Saveetha medical college and hospital |
Department of ENT, Saveetha medical college and hospital, Saveetha nagar, Thandalam, Chennai - 602105
Kancheepuram
TAMIL NADU |
7358159920
akshaya1308@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAVEETHA MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aneasthetic betadine gargle - an an advanced antiseptic for children with acute tonsillitis |
The effect of aneasthetic betadine gargle in paediatric acute tonsillitis is studied and compared with conventional betadine gargle |
| Comparator Agent |
Betadine gargle |
To know the effect in children with acute tonsillitis |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who are willing to undergo the study
2) Suspected patients with acute tonsillitis coming to er/op
|
|
| ExclusionCriteria |
| Details |
1) Patients who are not willing to undergo the study
2) Syndromic children
3) Chronic conditions of oropharynx
4) Cleft palate and cleft lip
5) Other acute conditions of oropharynx
6) Oral abscess |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This drug helps in preventing the progression of acute tonsillitis in children |
1 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It helps in alleviating pain in acute tonsillitis |
1 Week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
05/02/2026 |
| 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="0"
Months="1"
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
|
This study helps us in knowing the effect of aneasthetic betadine gargle in children with acute tonsillitis. The drug will be given to patients and its efficacy will be studied through a questionnaire |