| CTRI Number |
CTRI/2024/10/075408 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
understanding various types of Drug related problems such as incorrect dosages, wrong indications, duplicate drugs. |
|
Scientific Title of Study
|
Independent Prescription Audit in Community Pharmacies |
| 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 VIJAYANARAYANA K |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Dental OPD 4th floor, Madhav Nagar, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9448255124 |
| Fax |
|
| Email |
vijayanarayana.k@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIJAYANARAYANA K |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Dental OPD 4th floor, Madhav Nagar, Manipal, Karnataka.
KARNATAKA
576104
India |
| Phone |
9448255124 |
| Fax |
|
| Email |
vijayanarayana.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Apshan Rahamath |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Dental OPD 4th floor, Madhav Nagar, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9686923486 |
| Fax |
|
| Email |
apshan.mcopsmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Radha Medicals 1st Floor, Raja Tower Building, Bus Stand Road, Udupi, Karnataka. 576101
|
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education,Udupi KARNATAKA 576104 India |
| Type of Sponsor |
Research institution |
|
|
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 Vijayanarayana K |
Kasturba medical hospital |
Department of Pharmacy Practice, 4th floor, MCODS, via New OPD block, Kasturba Hospital, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104.
Udupi
KARNATAKA |
9448255124
vijayanarayana.k@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications, (2) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (3) ICD-10 Condition: Z798||Other long term (current) drug therapy, (4) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
✓ All prescriptions dispensed during the study period are included.
✓ Prescriptions with complete set of data that includes patient age, gender, strength, dose, duration Prescribed. |
|
| ExclusionCriteria |
| Details |
✓Incomplete prescriptions.
✓ Prescriptions of patient who deny to provide consent. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the prescription pattern in community pharmacy will be understood.
DRPs will be identified
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
28/10/2024 |
| 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="9"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Drug related problems are serious worldwide problems that threatens the foundations of modern medicine and can result in increased morbidity and mortality. Hence to address this problem and to guide appropriate prescribing patterns this project is carried out. Therefore, evaluating the prescription patterns in community pharmacies based on PNCE classification helps us to understand Drug related problems |