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CTRI Number  CTRI/2018/05/014159 [Registered on: 29/05/2018] Trial Registered Retrospectively
Last Modified On: 16/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Drug usage in geriatric patients visiting medicine outpatient department 
Scientific Title of Study   “Drug utilization study in geriatric patients of medicine out-patient department”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradeep G Jadhav 
Designation  Junior Resident 
Affiliation  Government Medical College,Miraj 
Address  Department Of Pharmacology,Pandharpur Road Government Medical College,Miraj.

Sangli
MAHARASHTRA
416410
India 
Phone  9764549422  
Fax    
Email  dr.jadhavpg15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunita J Ramanand 
Designation  Professor and Head 
Affiliation  Government Medical College,Miraj 
Address  Department Of Pharmacology,Pandharpur Road Government Medical College,Miraj.

Sangli
MAHARASHTRA
416410
India 
Phone  7218664433  
Fax    
Email  sjramanand@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sunita J Ramanand 
Designation  Professor and Head 
Affiliation  Government Medical College,Miraj 
Address  Department Of Pharmacology,Pandharpur Road Government Medical College,Miraj.

Sangli
MAHARASHTRA
416410
India 
Phone  7218664433  
Fax    
Email  sjramanand@gmail.com  
 
Source of Monetary or Material Support  
NOT APPLICABLE 
 
Primary Sponsor  
Name  Pradeep G Jadhav  
Address  Department of Pharmacology, Government Medical College, Miraj, Pandharpur Road, Miraj 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pradeep G Jadhav  Government Medical College and Hospital Miraj  OPD No 8, Medicine outpatient department,Government Medical College,Miraj, Pandharpur Road, Miraj.
Sangli
MAHARASHTRA 
9764549422

dr.jadhavpg15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Geriatric patients visiting Medicine outpatient department,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Prescription data of all patients above age 60yrs of medicine out-patient department . 
 
ExclusionCriteria 
Details  Patients below age 60yrs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Drug utilization pattern using WHO core indicators in geriatric patients of medicine outpatient department  Six months 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of the commonly used class of drugs in the above patients.  Six months 
Exposure rates of different class of drugs in the geriatric patients.
 
Six months 
Comparison of the results of drug utilization with Beer’s criteria  Six months 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   01/01/2018 
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)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Background:

Geriatrics is a branch of medicine dealing with the physiologic characteristics of aging and the diagnosis and treatment of diseases affecting the aged.

In most of the countries in the world including India cut-off point for geriatric age is 60 yrs. Recent increase  in the proportion and number of elderly in many developing countries have drawn attention to issues concerning the morbidity profile of this potentially vulnerable age group.

As per the 1991 census the elderly population in India was 57 million as compared with 20 million in 1951.As per 2011 census there are nearly 104 million elderly persons; 53 million female and 51 million males. It has been projected that by the year 2050, the number of elderly people would rise to about 324 million. More than half of the geriatric people are suffering from any sort of physical morbidity.

The 2012 American Geriatrics Society Beers Criteria, they include lists of potentially inappropriate medications to be avoided in older adults. New to the criteria are lists of select drugs that should be avoided or have their dose adjusted based on the individual’s kidney function and select drug–drug interactions documented to be associated with harm in older adults. The specific aim was to have a 13-member interdisciplinary panel of experts in geriatric care and pharmacotherapy update the 2012 AGS Beers Criteria using a modified Delphi method to systematically review and grade the evidence and reach a consensus on each existing and new criterion. The process followed an evidence-based approach using Institute of Medicine standards. The 2015 AGS Beers Criteria are applicable to all older adults with the exclusion of those in palliative and hospital care.

The intentions of the criteria include:

1) Improving the selection of prescription drugs by clinicians and patients;

2) Evaluating patterns of drug use within populations;

3) Educating clinicians and patients on proper drug usage; and

4) Evaluating health-outcome, quality of care, cost, and utilization data.

     Purpose of the study:

 The present study intends to study drug utilization pattern in geriatric patients of medicine outpatient department using WHO core indicators & study exposure rates & compare with Beer’s criteria.



 
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