| CTRI Number |
CTRI/2022/07/043743 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
04/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two drugs in treatment of ear perforation. |
|
Scientific Title of Study
|
To Compare The Efficacy Of Topical Acetic Acid Instillation With Topical Ciproflixacin In Medical Management Of Tubotympanic Chronic Suppurative Otitis Media. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paridhi Goyal |
| Designation |
1st Year ENT Resident |
| Affiliation |
Government Medical College , Bhavnagar |
| Address |
703 PG Hostel 2
Sir T Hospital Campus ,
Jail road , Bhavnagar.
ENT Department, Sir T Hospital campus, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7742880055 |
| Fax |
|
| Email |
goyalparidhi072@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil G Jha |
| Designation |
Head of Department in Otorhinolaringology |
| Affiliation |
Government Medical College , Bhavnagar |
| Address |
Sir T Hospital , Jail road , Bhavnagar.
ENT Department, Sir T Hospital,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uditkumar Chawda |
| Designation |
1st year ENT Resident |
| Affiliation |
Government Medical College , Bhavnagar |
| Address |
501 PG Hostel 3
Sir T Hospital Campus ,
Jail road , Bhavnagar.
ENT Department, Sit T Hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
uditchawda18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology, Sir T Hospital , Government Medical College , Bhavnagar. |
|
|
Primary Sponsor
|
| Name |
Department of Otorhinolaryngology |
| Address |
Sir T Hospital , Jail road , Bhavnagar. |
| 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 |
| Dr Paridhi Goyal |
Department of Otorhinolaryngology |
Sir T Hospital , Jail road , Bhavnagar.
Bhavnagar
GUJARAT |
7742880055
goyalparidhi072@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRb , GMC , Bhavnagar |
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 |
Topical acetic acid Drops |
We will prescribe acetic acid (2%) ear drops 5 drops 5 times for 14 days in cases of tubotympanic type of chronic suppurative otitis media. |
| Comparator Agent |
Topical Ciprofloxacin ear drops |
we will prescribe Topical ciprofloxacin (0.3% w/v)ear drops 5 drops 5 times for 14 days drops in cases of tubotympanic type of chronic suppurative otitis media. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with tubo-tympanic chronic suppurative otitis media in both sexes with age between 15 to 60 years.
2.Only outpatients will be included.
3.Patients with tubotympanic chronic suppurative otitis media with atleast moderate central perforation.
|
|
| ExclusionCriteria |
| Details |
1. Age group below 15 and above 60 of all sexes
2. Attico antral type of CSOM
3. Complicated CSOM
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare which eardrop is better in releiving the complain of ear discharge. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whichever is best for maintaining primary outcome of study. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/07/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My study is about comparison between topical acetic acid irrigation and topical antibiotics. Patients with tubotympanic type of CSOM will be considered for study. 50-50 patients will be kept in two groups. In 50 patients , Acetic acid drops will be prescribed and in rest , topical antibiotic drops will be prescribe and then improvement in complain of ear discharge will be checked. |