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CTRI Number  CTRI/2024/03/064343 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 16/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Descriptive Study of the Prescribing Pattern of Drugs in Chronic Suppurative Otitis Media and Impact of Disease on Health-Related Quality of Life in Patients Attending ENT OPD at SMS HOSPITAL, Jaipur 
Scientific Title of Study   A Descriptive Study of the Prescribing Pattern of Drugs in Chronic Suppurative Otitis Media and Impact of Disease on Health-Related Quality of Life in Patients Attending Otorhinolaryngology Out Patient Department at Sawai Man Singh Hospital, Jaipur 
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. Prateek Saini 
Designation  M.D pharmacology resident 
Affiliation  department of pharmacology, SMS Medical College 
Address  Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004 India
Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004 India
Jaipur
RAJASTHAN
302004
India 
Phone  9785908055  
Fax    
Email  prateeksaini798@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. RUPA KAPADIA 
Designation  Senior Professor  
Affiliation  Sawai man Singh medical College and hospital Jaipur  
Address  Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004, India
Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004, India
Jaipur
RAJASTHAN
302004
India 
Phone  9929871911  
Fax    
Email  drrupakapadia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR. Prateek Saini 
Designation  M.D pharmacology resident 
Affiliation  Sawai man Singh medical College and hospital Jaipur  
Address  Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004, India
Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004 India
Jaipur
RAJASTHAN
302004
India 
Phone  9785908055  
Fax    
Email  prateeksaini798@gmail.com  
 
Source of Monetary or Material Support  
department of ear nose throat second floor building sawai man singh medical college jaipur 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR PRATEEK SAINI  ear nose throat out patient clinic DHANVANTARI BHAWAN SMS HOSPITAL JAIPUR  Sawai man Singh road SMS Hospital Jaipur Rajasthan
Jaipur
RAJASTHAN 
9785908055

PRATEEKSAINI798@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, S.M.S. Medical College And Attached Hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H664||Suppurative otitis media, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient diagnosed with CSOM with or without active recurrent otorrhea and visible tympanic membrane perforation, visiting OPD of Otorhinolaryngology department.
Adult patient of either sex. Patients willing to give written informed consent for the study.
 
 
ExclusionCriteria 
Details  1. Patients with non-infective conditions, E.g., Malignancy and Road traffic accidents.
2. Patients with aural discharge with any cause other than CSOM. E.g., foreign body, furunculosis, and post-operative patients of CSOM.
3. Patients with co-morbid conditions like cancer, HIV, hepatitis.
4. Patients are part of any other study.
5. Non corporative patients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Active aural discharge   6 month  
 
Secondary Outcome  
Outcome  TimePoints 
1. Average number of drugs per encounter
2. Percentage of drugs prescribed with the generic name
3. Percentage of encounters with antimicrobials prescribed
4. Percentage of encounters with injections prescribed
5. Percentage of drugs prescribed from Essential Drugs List (EDL)
6. Proportion of drugs prescribed rationality as per the Standard Treatment Guidelines (6th Edition)
7. Mean QOL scores based on the COMOT-15 Questionnaire in the enrolled patients
8. Proportion of cases developing Adverse drug reactions (ADRs) to the prescribed drugs
9. Describe tantimicrobial susceptibility pattern of different pathogenic bacteria
 
6 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   N/A 
Date of First Enrollment (India)   29/03/2024 
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  

Chronic suppurative otitis media (CSOM) is a chronic infective, inflammatory disorder of the middle ear characterized by recurrent otorrhea for at least   2–6 weeks, through tympanic membrane perforation.1 It causes a myriad of intermittent or persistent symptoms across all age groups like ear discharge, hearing loss, tinnitus, and vertigo. CSOM has emerged as one of the most common causes of acquired hearing loss.2 It is a common condition encountered in the Ear, Nose, and Throat (ENT) department worldwide. A systematic analysis done by Vos et al. revealed that worldwide approximately 4.4% of the human population is affected by chronic suppurative otitis media (CSOM).3 The World Health Organization (WHO) estimates CSOM incidence between 65-330 million with, 50% of individuals with hearing impairment.3

 

CSOM can lead to significant morbidities, including hearing loss, recurrent infections, and potential complications such as mastoiditis, cholesteatoma, and intracranial infections.4 The management of CSOM typically involves a combination of medical and surgical interventions. Antibiotics play an important role in controlling infection and promoting healing of the middle ear infection. However, the irrational and inappropriate use of antibiotics can contribute to the emergence and spread of antimicrobial drug resistance, which is a global public health concern.5

 

WHO defined Drug Utilization Research as, “Studies of the marketing, distribution, prescription, and use of drugs in a society, with special emphasis on the resulting medical, social, and economic consequences”. This study aims to critically analyse the prescriptions issued at the  ENT outpatient department of the hospital. This study is to find out areas that need improvement in the overall interest of the patient and the healthcare system.6

 

Drug utilization monitoring can be used to assess the Rational use of drug therapy, outcome of treatment, and quality of life care. CSOM can also a produce significant impact on the quality of life of the affected individuals. In many cases, CSOM patients suffer from many complications like hearing loss, emotional impact, impact on day-to-day activities, social impact, and its impact on sleep. The present study was planned to evaluate the prescribing pattern of drugs along with the study of the impact of disease on health-related quality of life (QOL) in patients suffering from CSOM.7

 

WHO defined Rational use of drugs as “A state in which medications are received by patients appropriately according to their clinical needs and individual requirements, for an adequate period at the lowest cost”. The various repercussions of irrational drug use include polypharmacy, increased use of branded drugs, increased drug cost per person, drug interactions, adverse effects, irrational antibiotic prescribing, and antibiotic resistance and it may lead to a post-antibiotic era, then it will be very difficult to treat even mild infections. This justifies the need for an antibiotic policy that comprises microbiological data and prescription auditing in any geographical area. Rational use of antimicrobial agents requires proper clinical evaluation, judgment, and a comprehensive understanding of microbiological and pharmacological factors, and only through the rational prescribing practices of the clinician, the overuse and misuse of antibiotics issues can be resolved globally.8

 

Due to the irrational use of antibiotics, Antimicrobial Resistance (AMR) is also increasing among the pathogens causing CSOM. This necessitates the evaluation of antimicrobial drug susceptibility patterns in these patients on the basis of culture and sensitivity.9 Antimicrobial Stewardship is defined as “The careful and responsible management of something entrusted to one’s care”. It was originally applied in the healthcare setting as a tool for optimizing antimicrobial use, termed “Antimicrobial stewardship” (AMS). Stewardship has been applied in the context of governance of the health sector as a whole, taking responsibility for the health and well-being of the population and guiding health systems at the national and global levels.

AMS principles also apply to the use of antimicrobials in the animal and agriculture sectors, typically with an emphasis on the responsible and prudent use of these agents. Core Elements of Outpatient Antibiotic Stewardship provides guidance for antibiotic stewardship in outpatient settings and is applicable to any entity interested in improving outpatient antibiotic prescribing and use.10

 
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