| CTRI Number |
CTRI/2024/02/062914 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining medication usage patterns in post-operative patients: a study in the surgery department |
|
Scientific Title of Study
|
Drug Utilization study in Post Operative Patients in Surgery Department of Government Medical College Jammu: A prospective observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidushi Khajuria |
| Designation |
PG Resident |
| Affiliation |
Government Medical College, Jammu |
| Address |
Department of Pharmacology and Therapeutics, Second Floor, Government Medical College , Bakshi Nagar,Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
8491089971 |
| Fax |
|
| Email |
vidushykhajuria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabnam Choudhary |
| Designation |
Professor |
| Affiliation |
Government Medical College, Jammu |
| Address |
Department of Pharmacology and Therapeutics, Second Floor, Government Medical College , Bakshi Nagar,Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9697042817 |
| Fax |
|
| Email |
chawdhary.shabnam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidushi Khajuria |
| Designation |
PG Resident |
| Affiliation |
Government Medical College, Jammu |
| Address |
Department of Pharmacology and Therapeutics, Second Floor, Government Medical College , Bakshi Nagar,Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
8491089971 |
| Fax |
|
| Email |
vidushykhajuria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Jammu |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Jammu |
| Address |
Department of Pharmacology and Therapeutics, Second Floor, Government Medical College, Bakshi Nagar,Jammu |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shabnam Choudhary |
Professor,
Department of Pharmacology and Therapeutics, Second Floor, Government Medical College, Bakshi Nagar,Jammu |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidushi Khajuria |
Government Medical College, Jammu |
Ward No. 7 and 11 of Surgery Department
Jammu
JAMMU & KASHMIR |
8491089971
vidushykhajuria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College Institutional Ethical Committee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All the post-operative patients of inpatient ward will be included in the study.
2. Only drugs which are prescribed postoperatively will be considered. |
|
| ExclusionCriteria |
| Details |
1. Patients discharged against medical advice.
2. Patients referred to higher centre.
3. Patients expired in postoperative period before being discharged.
4. All pediatric patients.
5. Patients who did not give consent to study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To analyze the prescribing pattern of drugs in Post-operative patients from Surgery Department of Govt. Medical College Jammu using WHO prescribing indicators.
2. To examine the patterns of drug use using National list of essential medicines.
3. To study drugs prescribed per prescription
|
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The rationality of prescriptions will be evaluated using the WHO core prescribing indicators such as;
a) Average number of drugs prescribed.
b) Percentage of encounters with an antibiotic prescribed.
c) Percentage of encounters with an injection prescribed.
d) Percentage of drugs prescribed from National list of Essential Medicines (NLEM).
e) Percentage of drugs prescribed by generic names.
The percentage of the fixed-dose combinations (FDCs) will also be determined. Such WHO prescribing indicators assess the degree of poly-pharmacy, prescription of drugs by generic name and the use of antibiotics and injections. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
04/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
An observational, prospective study shall be conducted in the Post Graduate Department of Pharmacology and Therapeutics in collaboration with Department of Surgery, Government Medical College Jammu among the patients admitted in the surgery ward for a period of one year. Patients shall be briefed about the purpose of study in a vernacular language and a written informed consent shall be obtained prior to the commencement of the study. Confidentiality shall be maintained in all records. Data shall be recorded in the Patient Information Form. Detailed information of the patient such as name, age, gender, diagnosis and ongoing treatment will be recorded. Information on drugs prescribed post-operatively including name of the drug, dosing schedule (form, route and frequency) and duration of treatment will be recorded from the patient medical record sheet. The detailed information regarding the Post-operative patients and Post operatively prescribed drugs shall be collected indetail in patient information form. The rationality of prescriptions will be evaluated using the WHO core prescribing indicators such as; a) Average number of drugs prescribed. b) Percentage of encounters with an antibiotic prescribed. c) Percentage of encounters with an injection prescribed. d) Percentage of drugs prescribed from National list of Essential Medicines (NLEM). e) Percentage of drugs prescribed by generic names. The percentage of the fixed-dose combinations (FDCs) will also be determined. Such WHO prescribing indicators assess the degree of poly-pharmacy, prescription of drugs by generic name and the use of antibiotics and injections. The data collected shall be tabulated, interpreted and evaluated using appropriate Statistical Analysis. |