| CTRI Number |
CTRI/2025/05/087523 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on medicine use, side effects, and costs in elderly patients admitted to the hospital. |
|
Scientific Title of Study
|
Drug utilisation patterns, adverse drug reaction, cost, and
appropriateness of prescribed medicines in geriatric inpatients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chirag Bansal |
| Designation |
Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College , Bahadur Shah Zafar Marg , New Delhi
Central
DELHI
110002
India |
| Phone |
08103311614 |
| Fax |
|
| Email |
bansalchirag83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chirag bansal |
| Designation |
Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bhadur Shah Zafar Marg, New Delhi
Bhadur Shah Zafar marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
bansalchirag83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chirag Bansal |
| Designation |
Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
08103311614 |
| Fax |
|
| Email |
bansalchirag83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital , Jawaharlal Nehru Marg, Maulana Azad Medical College Campus, Delhi Gate, New Delhi, Delhi , India , Pin- 110002 |
|
|
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 |
| Dr Vandana Roy |
Lok Nayak Hospital |
Room no.- 148, Department of Pharmacology
New Delhi
DELHI |
99686 04283
roy.vandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are 60 years and above, of either sex, who have been admitted in medicine ward will be included in the study |
|
| ExclusionCriteria |
| Details |
Moribund patients on Intensive Care Support. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to evaluate the drug utilization patterns, appropriateness of prescriptions, costs, and adverse drug reactions among elderly inpatients. Findings will shed light on the frequency of inappropriate drug prescriptions and adverse reactions, prompting the development of new guidelines tailored for geriatric populations |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Addressing these issues could optimize healthcare spending & prevent economic burdens associated with medication costs, ultimately improving health outcomes & quality of life for elderly patients in hospital settings.
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
08/06/2025 |
| 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="3"
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
|
This study is a prospective, observational, single-centre trial evaluating drug utilization patterns, appropriateness of prescriptions, drug costs, and adverse drug reactions among geriatric inpatients aged 60 years and above. The study will be conducted over 3 months in one unit of the Department of Medicine at a tertiary care hospital in India. The primary outcome measure will be the drug utilization pattern assessed using parameters such as the average number of drugs per patient, ATC classification, and DDD/100 bed days. The secondary outcome measures will include the appropriateness of prescribed drugs based on the American Geriatrics Society 2023 Beers Criteria, total expenditure on prescribed drugs including ABC analysis, and incidence, severity, preventability, and causality of adverse drug reactions evaluated using the Naranjo algorithm, Hartwig and Siegel scale, and Schumock and Thornton criteria.
|