| CTRI Number |
CTRI/2024/03/064024 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of knowledge, attitude and perception of generic medicines among medical undergraduates in a tertiary care teaching hospital. |
|
Scientific Title of Study
|
Assessment of knowledge, attitude and perception of generic medicines among medical undergraduates in a tertiary care teaching hospital. |
| 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 Sheena Sethi |
| Designation |
Postgraduate student |
| Affiliation |
Government Medical College, Jammu |
| Address |
Government Medical College and Hospital, Bakshi nagar, Jammu, Jammu and Kashmir.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
7006362654 |
| Fax |
|
| Email |
drsheenasethi21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabnam Choudhary |
| Designation |
Professor |
| Affiliation |
Government Medical College, Jammu |
| Address |
Government Medical College and Hospital, Bakshi nagar, Jammu, Jammu and Kashmir.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9697042817 |
| Fax |
|
| Email |
chowdhary.shabnam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheena Sethi |
| Designation |
Postgraduate student |
| Affiliation |
Government Medical College, Jammu |
| Address |
Government Medical College and Hospital, Bakshi nagar, Jammu, Jammu and Kashmir.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
7006362654 |
| Fax |
|
| Email |
drsheenasethi21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Jammu |
|
|
Primary Sponsor
|
| Name |
Government medical college, Jammu |
| Address |
Government medical college, bakshi nagar, jammu, jammu and kashmir, 180001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sheena Sethi |
Government Medical College and Hospital, Jammu |
Department of Pharmacology and Therapeutics, Government Medical College and Hospital, Jammu, Jammu and Kashmir, 180001
Jammu
JAMMU & KASHMIR |
7006362654
drsheenasethi21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College, Jammu Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
All students of phase II MBBS |
|
| ExclusionCriteria |
| Details |
Students not willing to participate. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess knowledge, attitude, and perception of generic medicine among medical undergraduates. |
One day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="179"
Sample Size from India="179"
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)
|
01/04/2024 |
| 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
|
This questionnaire-based cross-sectional study will be conducted on second-year MBBS students at GMC, Jammu after attaining approval from the Institutional Ethics Committee. The purpose of the study will be explained and written informed consent will be obtained from all the participants before being given the questionnaires. The questionnaire comprises of four sections where section one consists of the demographic profile of the participants, and the second section consists of questions about knowledge regarding generic medicines. The third section carries questions related to the perception about generic medicines and the fourth part consists of questions about the attitude of students towards generic medicines. Responses such as yes and no were considered point descriptors
|