| CTRI Number |
CTRI/2025/10/095714 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Drug Errors and Interactions among Patients with Heart Diseases in a Hospital Setting |
|
Scientific Title of Study
|
Assessment of Medication Errors and Drug-Drug Interactions among Cardiovascular Disease Patients: A Clinical Pharmacist Perspective. |
| 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 Mandati Santhosh Reddy |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
KLE College of Pharmacy
Nehru Nagar, Belagavi
Assistant Professor
Department of Pharmacy Practice
Room no 24
Belgaum
KARNATAKA
590010
India |
| Phone |
7349022785 |
| Fax |
|
| Email |
santhoshreddy@klepharm.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Aiiravat Tambe |
| Designation |
Student |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
KLE College of Pharmacy
Nehru Nagar, Belagavi
Room no 24
Department of Pharmacy Practice
Belgaum
KARNATAKA
590010
India |
| Phone |
7349022785 |
| Fax |
|
| Email |
tambeaiiravat33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandati Santhosh Reddy |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
KLE College of Pharmacy
Nehru Nagar, Belagavi
Room no 24
Department of Pharmacy Practice
Belgaum
KARNATAKA
590010
India |
| Phone |
7349022785 |
| Fax |
|
| Email |
santhoshreddy@klepharm.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE College of Pharmacy |
| Address |
JNMC campus, Nehru Nagar, Belagavi
Pin code- 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Santhosh Reddy |
KLEs Dr Prabhakar Kore Hospital and MRC |
JNMC campus NEHRU NAGAR
Department of Cardiology and General medicine
G+4 4th floor
Belgaum
KARNATAKA |
9494601698
mandatisanthoshreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLECOPBGM ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I258||Other forms of chronic ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with cardiovascular patients with or without comorbidities
2. Both male and female patients of IPD and OPD of more than 18 years of age to 70 years of age.
3.Patients who are willing to Participate
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Patients who have incomplete medication records or do not have the clinical or laboratory data needed for evaluation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of medication errors and drug-drug interactions |
Baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
20/10/2025 |
| 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="6"
Days="0" |
|
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
|
Cardiovascular diseases (CVDs) are the leading cause of global mortality, with India reporting higher CVD-related death rates than the global average. The management of CVD often involves multiple medications, increasing the risk of medication errors (MEs) and drug-drug interactions (DDIs), which may lead to adverse drug reactions (ADRs), prolonged hospital stays, and higher healthcare costs. This prospective observational study aims to assess the incidence, types, and causes of medication errors and clinically significant DDIs among cardiovascular patients. It also seeks to evaluate the impact of clinical pharmacist interventions in identifying, preventing, and minimizing such medication-related problems. The study will be conducted in the Departments of Cardiology and General Medicine at KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, involving 160 patients. Data will be collected using validated tools such as the ASHP scale for medication errors, Micromedex for DDIs, and WHO-UMC and Hartwig & Siegel scales for ADR assessment. Statistical analysis will determine the effectiveness of pharmacist interventions in improving medication safety and patient outcomes. The findings are expected to highlight the crucial role of clinical pharmacists in ensuring safer pharmacotherapy for cardiovascular patients. |