| 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
|
|
|
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
|
|
|
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. |