| CTRI Number |
CTRI/2025/09/094218 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Community Pharmacists’ Understanding and Use of Generic Medicines |
|
Scientific Title of Study
|
Knowledge Attitude and Practice of Community Pharmacists On Generic Medicines |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajwal Gladson D Souza |
| Designation |
PG Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical sciences, Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8304020332 |
| Fax |
|
| Email |
gladsonpalengri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juno J Joel |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical sciences, Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Juno J Joel |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical sciences, Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of pharmacy practice, NGSM Institute of Pharmacuetical Sciences, Paneer, Deralakatte, Mangaluru |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of pharmacy practice, NGSM Institute of Pharmacuetical Sciences, Paneer, Deralakatte, Mangaluru |
| Type of Sponsor |
Other [Academic Institute] |
|
|
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 |
| Dr Juno J Joel |
Justice K.S Hegde Charitable Hospital |
Department of Pharmacy Practice
Dakshina Kannada
KARNATAKA |
9480470727
junojoel@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community Pharmacists |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Qualified community Pharmacists registered under state pharmacy council
Community Pharmacists who consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Unregistered practioners.
Pharmacists employed in Jan Aushadhi Kendras or generic medicine outlets. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Knowledge, attitude and practice of community pharmacists regarding generic medicines and to identify factors influencing their selection and dispensing behaviors. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="167"
Sample Size from India="167"
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)
|
17/09/2025 |
| 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
|
BRIEF INTRODUCTION OF THE PROTOCOL Generic medicines offer a cost-effective alternative to branded drugs without compromising efficacy or safety. Despite policy efforts like India’s Jan Aushadhi Scheme, the adoption of generics remains limited. Community pharmacists, being the final link in the healthcare delivery chain, significantly influence patient decisions and medication use.
OBJECTIVES OF STUDY To assess the knowledge, attitude, and practice (KAP) of community pharmacists regarding generic medicines in Mangaluru taluk and to identify factors influencing their selection and dispensing behaviors.
JUSTIFICATION OF THE STUDY Despite India’s role as a leading producer of generic medicines, their acceptance and utilization at the community level remain suboptimal. Community pharmacists, as accessible healthcare providers, play a pivotal role in promoting the use of generics. However, widespread misconceptions, lack of awareness, and inconsistent dispensing practices hinder effective generic substitution. Understanding the knowledge, attitude, and practice of pharmacists is essential to bridge these gaps, inform targeted educational interventions, and enhance the success of national health initiatives aimed at increasing access to affordable medicines.
METHODOLOGY An observational cross-sectional study will be conducted across community pharmacies in Mangaluru taluk. A validated questionnaire assessing KAP will be administered to registered pharmacists who meet the inclusion criteria. Demographic and professional details will also be collected. Data analysis will be performed using SPSS software, and appropriate statistical tools will be used to interpret findings.
STATISTICAL ANALYSIS Data will be analyzed using SPSS software. Quantitative data will be presented as mean ± standard deviation, while qualitative data will be summarized using frequency and percentage. Reliability of the questionnaire will be tested using Cronbach’s alpha, with values above 0.70 considered acceptable. Correlations and associations between knowledge, attitude, and practice will be evaluated using appropriate statistical tests, and a p-value < 0.05 will be considered statistically significant.
OUTCOME MEASURES The study aims to uncover gaps in pharmacists’ awareness and practices concerning generic medicines. The results are expected to inform policymakers, educators, and healthcare leaders about potential interventions like educational programs and policy reinforcements that could improve generic medicine promotion, pharmacist confidence, and ultimately, healthcare affordability.
|