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CTRI Number  CTRI/2024/08/072466 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Usage pattern of paracetamol among general medicine Outpatients. 
Scientific Title of Study   Perception and Practice towards the usage of Paracetamol among outpatients of General Medicine Department 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fathimathul Amani 
Designation  Student  
Affiliation  NGSM institute of pharmaceutical sciences  
Address  Department of Pharmacy Practice NGSM institute of Pharmaceutical sciences Paneer,Derlakatte,Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7349432601  
Fax    
Email  amanifathima2001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nandakumara UP 
Designation  Assistant Professor,Department of Pharmacy Practice 
Affiliation  NGSM institute of Pharmaceutical sciences 
Address  Department of Pharmacy Practice NGSM institute of pharmaceutical sciences,Paneer,Derlakatte ,Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9633023062  
Fax    
Email  nandakumarvtkv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrShuaib Ahmed MA 
Designation  Associate Professor  
Affiliation  K.S Hegde Medical Academy 
Address  Department of General Medicine K.S Hegde Medical Academy Deralakatte,Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9880322268  
Fax    
Email  shuaib9800@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice NGSM institute of Pharmaceutical sciences,Paneer,Derlakatte,Mangaluru,Karnataka,575018 
Justice K.S Hegde Charitable Hospital,Derlakatte,Mangaluru,Karnataka  
 
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 
DrShuaib Ahmed MA  Justice KS Hegde charitable Hospital  Department of General Medicine Justice K.S Hegde charitable hospital Derlakatte,Mangaluru,Dakshina Kannada ,Karnataka ,575018
Dakshina Kannada
KARNATAKA 
9880322268

shuaib9800@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z000||Encounter for general adult medical examination,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient of either gender, aged above 18 years, presenting to the outpatients department of General Medicine, who have consumed paracetamol tablets at least once in the last 12 months with or without prescription 
 
ExclusionCriteria 
Details  Patients who are not willing to take part in this study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will help to determine the perception and practice towards the usage of paracetamol .  8 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of perception and practice is critical in deciding the level of educational intervention to be initiated among the subjects so as to enhance their understanding and behaviour regarding the drug.  8 months 
 
Target Sample Size   Total Sample Size="462"
Sample Size from India="462" 
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)   24/08/2024 
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="8"
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  

INTRODUCTION

Paracetamol is a weak analgesic that is widely preferred for its effectiveness, low occurrence of adverse effects, and higher level of tolerance among the patients.However, self-medication with paracetamol, is effective and safe only if the consumers are knowledgeable about various aspects pertaining to the medication such as its intended use and profile of adverse effects associated with the drug.A lack of awareness while using OTC medicines can lead to poor user behaviors and health risks connected with medication misuse, such as undesirable side effects and allergic responses, drug interactions, and even overdose

OBJECTIVE

To design, validate, translate and test the reliability of questionnaire on perception and practice towards the usage of paracetamol.To assess the perception and practice of outpatients of general medicine department towards the usage of paracetamol.To compare the perception and practices towards the usage of paracetamol on the basis of socio-demographic characteristics.To find out the correlation between perception and practice towards the usage of paracetamol.

NEED FOR THE STUDY

Studying the perceptions and practices of the public regarding the usage of paracetamol is essential because of its widespread availability and frequent use, which may lead to misconceptions or improper practices. Identifying any gaps in knowledge or misconceptions can help tailor educational campaigns to address these issues, ensuring that individuals use paracetamol safely and effectively.

METHODOLOGY

Questionnaire on Perception and Practice towards the use of paracetamol will be created, validated, translated and then will be sujected to test-retest reliability. Outpatients of general medicine department of Justice K.S Hegde Charitable Hospital who had consumed paracetamol in the last 12 months with or without prescription and are willing to participate in the study will be enrolled. Details of the subjects including their socio-demographic parameters will be obtained and recorded in a data collection form. The previously validated Perception and Practice Questionnaire will be administered to the subjects to obtain their responses recorded in it. 

STATISTICAL ANALYSIS

Data analysis was performed using SPSS 29.0 at 95% confidence level.Categorical variables will be presented as frequency and percentage.Continuous variables will be presented as mean ± standard deviation.Perception and practice towards the usage of paracetamol will be expressed as mean ± standard deviation.Comparison of perception and practice on the basis of the socio-demographic variables will be analysed using Independent t-test/ ANOVA.Correlation of perception and practice will be analysed using Karl Pearson’scoefficient of correlation/Spearman’s rank correlation coefficient.Cronbach’s alpha value greater than 0.70 will be considered acceptable, on testing the questionnaire for reliability.A p value <0.05 will be considered statistically significant.

OUTCOME MEASURES

This study will help to determine the perception and practice towards the usage of paracetamol. Assessment of perception and practice is critical in deciding the level of educational intervention to be initiated among the subjects so as to enhance their understanding and behaviour regarding the drug.

 
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