| CTRI Number |
CTRI/2025/03/081991 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
TO COMPARE THE EFFICACY OF ACETIC ACID EAR DROPS VERSUS CIPROFLOXACIN EAR DROPS IN ACHIEVING DRY EARS IN ACTIVE TUBOTYMPANIC CHRONIC OTITIS MEDIA AN OBSERVATIONAL COMPARITIVE STUDY, IN , TERTIARY CARE CENTRE, SOUTH INDIA |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF ACETIC ACID EAR DROPS VERSUS CIPROFLOXACIN EAR DROPS IN ACHIEVING DRY EARS IN ACTIVE TUBOTYMPANIC CHRONIC OTITIS MEDIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KARTHIKA RAJENDRAN |
| Designation |
POST GRADUATE |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
DEPARTMENT OF ENT
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE POTHERI CHENGALPATTU
Department of ENT
SRMIST
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9567452328 |
| Fax |
|
| Email |
Karthikarajendran1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A. GRAHALAKSHMI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
DEPARTMENT OF ENT
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE POTHERI CHENGALPATTU
DEPARTMENT OF ENT
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE POTHERI CHENGALPATTU
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598438590 |
| Fax |
|
| Email |
graha710@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A. GRAHALAKSHMI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
DEPARTMENT OF ENT
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE POTHERI CHENGALPATTU
DEPARTMENT OF ENT
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE POTHERI CHENGALPATTU
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598438590 |
| Fax |
|
| Email |
graha710@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KARTHIKA RAJENDRAN |
| Address |
KARTHIKA NAVAIKULAM PO NAVAIKULAM |
| Type of Sponsor |
Other [OTHERS (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 |
| KARTHIKA RAJENDRAN |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Department of ENT
S.R.M NAGAR , POTHERI, KATTANKULATHUR,CHENGALPATTU DISTRICT
Chennai
TAMIL NADU |
9567452328
Karthikarajendran1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACETIC ACID EAR DROPS |
2% ACETIC ACID EAR DROPS WILL BE ADMINISTERED TO THE PATIENT AS A PART OF STUDY .SINEC ACETIC ACID EAR DROPS HELP TO ACHIEVE ACIDIC PH IN EAR AND ALSO HELPS TO DISTROY THE BIOFILMS. THUS ACETIC ACID HELPS TO PREVENT THE ANTIBIOTIC RESISTANCE DUE TO THE REPEATED USAGE OF ANTIBIOTIC EAR DROPS. |
| Comparator Agent |
Ciprofloxacin 0.3% , 2 drops as topical, drops twice a day |
CIPROFLOXACIN 0.3% CONCENTRATION AS TOPICAL FORM IN ACHIEVING DRY EARS IN ACTIVE TUBOTYMPANIC CHRONIC OTITIS MEDIA. USED TWICE A DAY , DOSAGE 2DROPS EACH TIME.CIPROFLOXACIN EAR DROPS BEING AN ANTIBIOTIC EAR DROPS ON FREQUENT USAGE CAUSES RESISTANCE AND ALSO ASSOCIATED WITH BIOFILM FORMATION. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females,
15-60 years
Patients with unilateral active tubotympanic chronic otitis media with symptoms more than 4 weeks.
Both outpatients and inpatients will be included.
|
|
| ExclusionCriteria |
| Details |
Patients with Atticoantral types of CSOM disease, cholesteatoma or with marginal perforation of the tympanic membrane.
Immunocompromised individuals.
Dry ear with CSOM. .
Serous Otitis Media.
CSOM with otomycosis.
CSOM with vertigo.
Patient on systemic antibiotics or any topical ear drop preparation preceding 2 weeks in group of patients selected for irrigation with acetic acid.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| acetic caid ear drops in efficient in achieving dry ears in chronic otitis media than ciprofloxacin ear drops |
study will be conducted for a period of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To eliminate antibiotic resistance due to repeated usage |
To eliminate antibiotic resistance due to repeated usage |
To evaluate the role of acetic acid application in obtaining dry ears in CSOM.
To corelate the efficacy of acetic acid application with microbiological culture sensitivity reports .
|
study will be conducted for a period of 2 years. |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is on the role of topical acetic acid in comparision with topical ciprofloxacin ear drops in achieving dry ears in chronic otitis media. The hypothesis of study is topical acetic acid administration is more effective than topical antibiotics in achieving dry ears in active tubotympa nic type of chronic otitis media. The aim is to compare the efficacy of aural clensing with acetic acid irrigation and topical ciprofloxacin in medical management of active COM tubotympanic type. The objective of study is to evaluate the role of acetic acid application in obtaining dry ears and to correlate the efficacy of acetic acid application with microbiological culture sensitivity reports.The study will be conducted for a period of 2 years.Patient included in the present study will be distributed in to two groups, group A will recievw topical treatment, irrigation with acetic acid and aural toiletting, group B patients will be treated with topical ciprofloxacin ear drops.Patient will be observed for 2 weeks and at end of 7 th day and 14th day patient will be assessed. |