| CTRI Number |
CTRI/2021/01/030577 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
15/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Drug related problems in surgery |
|
Scientific Title of Study
|
Assessment of Drug Related Problems among the inpatients of the department of general surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna Sajan |
| Designation |
Pharmacy Student |
| Affiliation |
NITTE GULABI SHETTY MEMORIAL INSTITUTE OF PHARMACEUTICAL SCIENCES |
| Address |
5th PHARM D, DEPARTMENT OF PHARMACY PRACTICE ,NGSM INSTITUTE OF PHARMACEUTICAL SCIENCES, AFFILIATED TO NITTE (DEEMED TO BE UNIVERSITY),PANEER, DERALAKATTE, MANGALURU, KARNATAKA, PIN: 575018
Dakshina Kannada
KARNATAKA
575 018
India |
| Phone |
08289853628 |
| Fax |
|
| Email |
aparnasajan2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandakumar UP |
| Designation |
Assisstant Professor |
| Affiliation |
NITTE GULABI SHETTY MEMORIAL INSTITUTE OF PHARMACEUTICAL SCIENCES |
| Address |
5th PHARM D, DEPARTMENT OF PHARMACY PRACTICE ,NGSM INSTITUTE OF PHARMACEUTICAL SCIENCES, AFFILIATED TO NITTE (DEEMED TO BE UNIVERSITY),PANEER, DERALAKATTE, MANGALURU, KARNATAKA, PIN: 575018
Dakshina Kannada
KARNATAKA
575 018
India |
| Phone |
09633023062 |
| Fax |
|
| Email |
nandakumar@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nandakumar UP |
| Designation |
Assisstant Professor |
| Affiliation |
NITTE Gulabi Shetty Memorial Institute Of Pharmaceutical Sciences |
| Address |
NITTE Gulabi Shetty Memorial Institute Of Pharmaceutical Sciences
Department Of Pharmacy Practice
Nitte deemed to be University
Paneer Campus
Derlakatte, Mangaluru, Karnataka, PIN: 575018
NITTE Gulabi Shetty Memorial Institute Of Pharmaceutical Sciences
Department Of Pharmacy Practice
Nitte deemed to be University
Paneer Campus
Derlakatte, Mangaluru, Karnataka, PIN: 575018
Dakshina Kannada
KARNATAKA
575 018
India |
| Phone |
09633023062 |
| Fax |
|
| Email |
nandakumar@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| self,department of pharmacy practice,NGSMIPS,Nitte(deemed to be university),paneer,derlakatte,mangaluru,karnataka,575018 |
|
|
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 |
| MsAmeena Sherin PM |
K S Hegde Charitable hospital |
DEPARTMENT OF PHARMACY PRACTICE ,NGSM INSTITUTE OF PHARMACEUTICAL SCIENCES, AFFILIATED TO NITTE (DEEMED TO BE UNIVERSITY),PANEER, DERALAKATTE, MANGALURU, KARNATAKA, PIN: 575018
Dakshina Kannada
KARNATAKA |
09946632096
pmameena2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, age , above 18 years who are admitted in the department of general surgery between January 2019 and December 2019 and prescribed with atleast one drug. |
|
| ExclusionCriteria |
| Details |
Medical records with incomplete information. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present study aims in the identification of both potential and actual DRPs among inpatients of general surgery department as well as major class of drugs associated with such problems.The study is expected to demonstrate the role of clinical pharmacist in detection and reporting of DRPs, which can lead to reduced hospitalization and economic burden of the patients. |
Single Point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study is expected to demonstrate the role of clinical pharmacist in detection and reporting of DRPs, which can lead to reduced hospitalization and economic burden of the patients. |
Single Point |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
25/01/2021 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: A Drug-Related Problem (DRP) is an event or circumstance involving drug
therapy that actually or potentially interferes with desired health outcomes.APS- Doc classification system for drug related problems can be used to
categorize the DRP’s identified during the course of this study. Objectives of the study: 1. To identify and categorise the drug related
problems among the inpatients of the department of general surgery using
APS-Doc classification system.
2. To identify the most
frequent class of drugs associated with drug related problems.
Methodology: A retropspective observational study will be conducted for a duration of 6 months. Patient data collection, DRP reporting and documentation will be prepared. Details regarding the treatment given to the patients will be noted.Patient’s treatment records will be thoroughly revised and once the DRP is identified, it will be categorised according to the APS- Doc system, and the most frequent class of drugs associated with the DRPs will be identified. Anticipated Outcomes: The present study aims in the identification of both potential and actual DRPs among inpatients of general surgery department as well as the major class of drugs associated with such problems. The study is expected to demonstrate the role of clinical pharmacists in detection and reporting of DRPs, which can lead to reduced hospitalization and economic burden of the patients.
|