| CTRI Number |
CTRI/2020/10/028303 [Registered on: 08/10/2020] Trial Registered Prospectively |
| Last Modified On: |
03/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Drug utilization study in Pimpri Chinchwad (PCMC) area of Pune |
|
Scientific Title of Study
|
A prospective, observational drug utilization study evaluating prescribing patterns in out-patient department of private hospitals in Pimpri Chinchwad (PCMC) area of Pune |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amol Gujar |
| Designation |
Research Scholar- Ph.D student |
| Affiliation |
Sandip University |
| Address |
Room number: 201
Department: School of Pharmaceutical Sciences,
Division: Pharmacy
Sandip University, Trambakeshwar Rd, Mahiravni, Maharashtra 422213
Nashik
MAHARASHTRA
422213
India |
| Phone |
9730475016 |
| Fax |
|
| Email |
amolgujar17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal S Gulecha |
| Designation |
Dean |
| Affiliation |
Sandip University |
| Address |
Department: School of Pharmaceutical Sciences,
Sandip University, Trambakeshwar Rd, Mahiravni, Maharashtra 422213
Nashik
MAHARASHTRA
422213
India |
| Phone |
9730475016 |
| Fax |
|
| Email |
deanpharmacy@sandipuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Amol Gujar |
| Designation |
Research Scholar- Ph.D student |
| Affiliation |
Sandip University |
| Address |
Room number: 201
Department: School of Pharmaceutical Sciences, Division: Pharmacy
Sandip University, Trambakeshwar Rd, Mahiravni, Maharashtra 422213
Nashik
MAHARASHTRA
422213
India |
| Phone |
9730475016 |
| Fax |
|
| Email |
amolgujar17@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Pharmaceutical Sciences, Sandip University, Nashik. |
|
|
Primary Sponsor
|
| Name |
Amol Gujar |
| Address |
Sandip University, Trambakeshwar Rd, Mahiravni, Maharashtra 422213 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amol Gujar |
Gholap Hospital and Nursing Home |
Savatha Mali Nagar, Chikhali, Pimpri-Chinchwad, Pune, Maharashtra 412105, India
Pune
MAHARASHTRA |
9730475016
amolgujar17@gmail.com |
| Amol Gujar |
Kabre Orthopaedic, Spine and Dental Centre |
Plot No SEI 4/1, D II Block, Telco Road, MIDC, Chinchwad, Pimpri-Chinchwad, Pune, Maharashtra 411019, India
Pune
MAHARASHTRA |
9730475016
amolgujar17@gmail.com |
| Amol Gujar |
Krishna Hospital |
Jyotiba Nagar, Kalewadi, Pimpri-Chinchwad, Pune, Maharashtra 411017, India
Pune
MAHARASHTRA |
9730475016
amolgujar17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Kabre Institutional Ethics Committee |
Approved |
| Kabre Institutional Ethics Committee |
Approved |
| Kabre 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 |
1.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Prescription data of all patients visiting identified private hospital out-patient department |
|
| ExclusionCriteria |
|
|
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 prescribing indicators for prescriptions of patients visiting identified private hospitals outpatient department |
This is a cross-sectional study and will have a time period of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The principal aim of drug utilization research is to facilitate the rational use of
drugs in populations. Drug utilization research in itself does not necessarily
provide answers, but it contributes to rational drug use as drug utilization
studies increase the understanding of how drugs are being used and it describes
not only the drug prevalence and incidence but also the extent of use at a certain
moment and/or in a certain area. Such descriptions are most meaningful and they
form part of a continuous evaluation system. The
WHO has recommended 5 prescribing indicators. Each of these
indicators is:
1) Important
and reflect an important dimension of performance. Even though data may be
readily and consistently available, they may not indicate anything important
about the system performance.
2) Measurable
within existing constraints of time and variable quality and availability of
source data.
3) Reliable as
it gives consistent results over time and with different observers.
4) Valid
and allow a consistent and clear interpretation and have a similar meaning
across different environments
Purpose of the study:
The present study
intends to study drug utilization pattern by evaluating prescriptions
of patient visiting outpatient department of identified private hospitals using
WHO core prescribing indicators |