| CTRI Number |
CTRI/2024/03/064148 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial about Comparing effectiveness and side effects of Amoxicillin-clavulanic acid versus ciprofloxacin in patient
of chronic suppurative otitis media in a
hospital |
|
Scientific Title of Study
|
Comparison of efficacy and safety of Amoxicillin-clavulanic acid versus ciprofloxacin in patient
of active stage of tubotympanic type of chronic suppurative otitis media in a tertiary care
hospital - a prospective, randomized, Open-label study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRIRAMAGIRI SAI VINAY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Indira Gandhi Government medical college and Hospital |
| Address |
Dr.S.Sai Vinay, Junior resident, Dept. of pharmacology, Indira Gandhi Government medical college and Hospital, CA road, Nagpur, Maharastra
Nagpur
MAHARASHTRA
440018
India |
| Phone |
8985454858 |
| Fax |
|
| Email |
saivinay1947@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VANDANA AVINASH BADAR |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
Indira Gandhi Government medical college and Hospital |
| Address |
Dept. of pharmacology, Indira Gandhi Government medical college and Hospital, CA road, Nagpur, Maharastra
Nagpur
MAHARASHTRA
440018
India |
| Phone |
9960031486 |
| Fax |
|
| Email |
drvandanabadar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRIRAMAGIRI SAI VINAY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Indira Gandhi Government medical college and Hospital |
| Address |
Dr.S.Sai Vinay, Junior resident, Dept. of pharmacology, Indira Gandhi Government medical college and Hospital, CA road, Nagpur, Maharastra
Nagpur
MAHARASHTRA
440018
India |
| Phone |
8985454858 |
| Fax |
|
| Email |
saivinay1947@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Government medical college and Hospital |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Government medical college and Hospital |
| Address |
Indira Gandhi Government medical college and Hospital, CA road, Nagpur, Maharastra- 440018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SRIRAMAGIRI SAI VINAY |
Indira Gandhi Government medical college and Mayo Hospital |
Dept. of pharmacology, Dean office Building, Central Avenue road, Momnipura, Nagpur, Maharashtra - 440018
Nagpur
MAHARASHTRA |
8985454858
saivinay1947@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC)/ Board Of Research Studies (BORS) Indira Gandhi Government medical college and Hospital |
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 |
Amoxicillin- clavulanic acid |
a single 625 mg tablet given orally twice a day for 7 days |
| Comparator Agent |
Ciprofloxacin |
500mg tablet given orally twice a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants to be attending the outpatient clinic in the department of ENT,
1. Adults of either sex, greater than 18 years
2. Clinically documented or New cases of a tubo-tympanic variety of CSOM with clinical signs
& symptoms of the disease and baseline otological symptom score of >4 but ≤ 8 were
included in the study12
3. Patients willing to participate in the study by giving Informed consent
4. Outpatient department |
|
| ExclusionCriteria |
| Details |
1. Atticoantral type of chronic suppurative otitis media
2. Age less than 18 years
3. Impending complications
4. Patients with acute otitis media and all physical and other subtypes of otitis media, such
as otitis media with effusion.
5. Otomycosis
6. Severe cases of CSOM for which hospitalization or parenteral antibiotic treatment is
required and patients with otological symptom score of ≤4 and >8 were also excluded
from the study
7. Patients with foul-smelling Ear discharge
8. Large aural polyp in the middle ear
9. Patients who, received antibiotics either topical or systemic in the preceding 4 weeks of
screening
10.Otological surgery within the past year
11. Presence of tympanostomy tube
12. Acute traumatic perforation
13. Symptomatic conditions such as otitis externa, chronic sinusitis, chronic pharyngitis
requiring systemic antibiotic therapy that could interfere with the evaluation of study
drugs
14. History of allergies to the study medication
15. Acute serious illness (like Myocardial Infarction, Stroke, Sepsis, Electrolyte disturbances)
16. Known case of any malignancy
17. Known case of any liver and kidney disease
18.Pregnant women and lactating mothers
19. Patients in Inpatient department
20. Underlying chronic diseases such as Diabetes mellitus, Tuberculosis
21. Known case of immunodeficiency.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients showing complete stoppage of otorrhea at the end of 2 weeks |
reduction of otorrhea after 3 days, 1 week and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ear discharge must be sterile or no pus after completion of course of treatment
|
ear discharge will be swabbed at day 0 and day 14 |
Recording of adverse event, if any, according to the prescribed proforma issued by
Pharmacovigilance program of India (PvPI). |
adverse drug reactions are noted at any point of time after drug intake |
| Analyzing the cost-effective analysis of antimicrobials |
cost effective analysis will be done at day 0 , day 3 , day7 and day 14 |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/04/2024 |
| 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="6"
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 is a prospective, randomized, controlled clinical open-labelled study. The
study was approved by the Institutional Ethics committee and will be done according to the ICMR guidelines for Biomedical Research on Human subjects, 2006
and the Declaration of Helsinki. Subjects were recruited in the ENT outpatient Department of a
tertiary care teaching hospital. |