| CTRI Number |
CTRI/2024/02/063228 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to assess Pharmacist Awareness and Practices on Drug Safety in North Bengaluru India |
|
Scientific Title of Study
|
Comparison of knowledge, attitude and practice of Pharmacovigilance and adverse drug reaction
reporting among hospital pharmacist and community pharmacists in Bengaluru, India: A Cross sectional questionnaire-based study.
|
| 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 Aditya V |
| Designation |
Professor |
| Affiliation |
Gautham College of Pharamcy |
| Address |
Gautham College of Pharmacy Pharmacy Practice
Division II Room No. 7 Vishwanath Naganahalli Main Rd Kanaka Nagar Hebbal Bengaluru Karnataka
Bangalore
KARNATAKA
560032
India |
| Phone |
9008427619 |
| Fax |
|
| Email |
adithyavh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditya V |
| Designation |
Professor |
| Affiliation |
Gautham College of Pharamcy |
| Address |
Gautham College of Pharmacy Pharmacy Practice
Division II Room No. 7 Vishwanath Naganahalli Main Rd Kanaka Nagar Hebbal Bengaluru Karnataka
Bangalore
KARNATAKA
560032
India |
| Phone |
9008427619 |
| Fax |
|
| Email |
adithyavh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srilakshmi R Bhat |
| Designation |
Student |
| Affiliation |
Gautham College of Pharamcy |
| Address |
Gautham College of Pharmacy Pharmacy Practice Division II Room No. 7 Vishwanath Naganahalli Main Rd Kanaka Nagar Hebbal Bengaluru Karnataka
Bangalore
KARNATAKA
560032
India |
| Phone |
9483183253 |
| Fax |
|
| Email |
srilakshmirbhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guatham College of Pharmacy Vishwanath Naganahalli Main Rd Kanaka Nagar Hebbal Bengaluru Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Aditya V |
| Address |
Vishwanath Naganahalli Main Rd Kanaka Nagar Hebbal Bengaluru Karnataka 560032 |
| Type of Sponsor |
Other [Self] |
|
|
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 Aditya V |
Gautham College of Pharmacy |
Pharmacy Practice Division II Room No. 7 Vishwanath Naganahalli Main Rd Kanaka Nagar Hebbal Bengaluru Karnataka
Bangalore Rural
KARNATAKA |
9008427619
adithyavh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community pharmacist- Those practicing in retail pharmacies within North Bengaluru
Hospital Pharmacist-Pharmacist working in healthcare facilities in North Bengaluru |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The community and hospital pharmacist in North Bengaluru India who give their informed consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
Participants who do not provide their consent will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be measured using a suitable self-administered questionnaire designed by referring similar kinds of literatures with input from the experts using both open and closed ended questions and some modifications were made to the questionnaire which is used to compare the knowledge, attitude and practice of Pharmacovigilance and Adverse Drug Reaction reporting among hospital pharmacist and community pharmacists in North Bengaluru India. |
At baseline 4 weeks 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The outcome will be measured using a suitable self-administered questionnaire designed by referring similar kinds of literatures with input from the experts using both open & closed ended questions & some modifications were made to the questionnaire which is used to evaluate knowledge, attitude, practice & future perspective on Pharmacovigilance & Adverse reaction reporting among hospital pharmacist & community pharmacists in North Bengaluru India. |
At baseline 2 weeks 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
06/03/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This study aims to compare of knowledge, attitude and practice of Pharmacovigilance and adverse drug reaction reporting among hospital pharmacist and community pharmacists in North Bengaluru, India as they are first to be contacted by the patients for medications using pre-validated questionnaire |