FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/063166 [Registered on: 26/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Antifungal Drug Prescription Pattern in Out Patient Department of Skin & VD, SMS Hospital, Jaipur 
Scientific Title of Study   An Observational Study for Antifungal Drug Prescription Pattern in Out Patient Department of Skin & VD, SMS 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 Anil Kumar Sharma 
Designation  MD Pharmacology Resident 
Affiliation  Department of Pharmacology, SMS Medical College 
Address  Department of Pharmacology SMS Medical College jaipur

Jaipur
RAJASTHAN
302004
India 
Phone    
Fax    
Email  jangir.apiary@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chetna Meena 
Designation  Senior Professor 
Affiliation  SMS Medical College 
Address  Department of Pharmacology SMS Medical College jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9414980943  
Fax    
Email  chetnamahak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Kumar Sharma 
Designation  PG Resident 
Affiliation  SMS Medical College 
Address  Department of Pharmacology SMS Medical College jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9214688970  
Fax    
Email  jangir.apiary@gmail.com  
 
Source of Monetary or Material Support  
Dermatology OPD Ground Floor Charak Bhawan SMS Hospital 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 Anil Kumar Sharma  SMS hospital  Department of SKIN & VD Charak Bhawan SMS Hospital Jaipur
Jaipur
RAJASTHAN 
9214688970

jangir.apiary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of The Etics Committee SMS Medical College and Attached Hospital Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  79.00 Year(s)
Gender  Both 
Details  Patients who have been prescribed at least one antifungal drug.
Patients willing to give consent for participation in study.
 
 
ExclusionCriteria 
Details  Patients having any skin infection other than fungal infection.
Psychiatric Patients with skin disorder and unable to give informed written consent with no attendants.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of prescriptions as per WHO prescribing indicators
Correlation of antifungal use according to clinical profile of patients.
Correlation of antifungal drug use according to sociodemographic profile of the patients.
Percentage of concomitant drugs/ antimicrobials.
Percentage of cases developing Adverse drug reactions (ADRs) to antifungal Drugs. 
6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse Drug Reaction  6 months 
 
Target Sample Size   Total Sample Size="307"
Sample Size from India="307" 
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)   01/03/2024 
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  

•Skin is the largest organ and is the first protective barrier that is exposed to various environmental and chemical factors, as well as infections.

•Skin diseases affect almost 900 million people in the world at any time, are among the highest of all human diseases & the fourth leading cause of nonfatal disease burden worldwide.

•The earliest most common fungal infections which are Tinea Corporis (Ring-worm) and Tinea Cruris (Jock Itch).

•Fungal infections can affect the quality of life of affected individuals with significant impact on sleep patterns, emotions & social life.

•Currently, five common classes of antifungal drugs such as Azoles, Polyenes, Echinocandins, Allylamines and Pyrimidine analogs are available for superficial and systemic antifungal therapies.

•Among these, Azole class of drugs includes Imidazoles (Miconazole and Ketoconazole) and Triazoles (Fluconazole and Voriconazole) have been the most successful backbone.

•Large varieties of systemic as well as topical antifungal agents are available in the market. Some newer antifungal agents are flooding into the market in current days e.g. Eberconazole and Posaconazole.

•The WHO has developed three highly standardized core drug use indicators.5 These are prescribing indicators, patient care indicators, and facility indicators.

•Hence this study aims to evaluate the prescription pattern with distribution of fungal disease.

•Prescription of drugs requires expertise in diagnostics, an understanding of common medications and their therapeutic effects, adverse effects, and drug interactions, a grasp of the fundamentals of clinical pharmacology, communication abilities, and the capacity to weigh the pros and cons of treatment.

•In tropical countries like India, Fungal infections are more common and have increased in the last four decades due to environmental factors, increased use of broad spectrum antifungal agents and increasing prevalence of patients with immune deficiency states.

•Frequency of invasive fungal infections with the emergence of new species of pathogenic fungi have increased vastly, so rational use of antifungal drugs in clinical practice has important implications for patient care as it can facilitate their rational use for prophylaxis, empirical, pre-emptive & targeted treatment.

•The purpose of the present study is to understand the prescribing pattern of antifungal agents, their use will be standardized as per WHO prescribing indicators, also analyzing the factors such as the choice, dosages, treatment duration, and considerations of patient demographics and co-morbidities, which will enhance the rational use of antifungal drugs.

 
Close