| CTRI Number |
CTRI/2024/07/071525 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of drugs prescribed in Diabetes and their side effects. |
|
Scientific Title of Study
|
Analysis of Prescribing pattern and Adverse drug reactions of Anti-diabetic drugs in patients of Type 2 Diabetes Mellitus in a tertiary care teaching hospital - 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 |
Dr Sheena Sethi |
| Designation |
Postgraduate student |
| Affiliation |
Government Medical College, Jammu |
| Address |
Postgraduate Department of Pharmacology and Therapeutics, Government Medical College and Hospital, Bakshi nagar, Jammu,
Jammu and Kashmir.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
7006362654 |
| Fax |
|
| Email |
drsheenasethi21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabnam Choudhary |
| Designation |
Professor |
| Affiliation |
Government Medical College, Jammu |
| Address |
Postgraduate Department of Pharmacology and Therapeutics, Government Medical College and Hospital, Bakshi nagar, Jammu,
Jammu and Kashmir.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9697042817 |
| Fax |
|
| Email |
chawdhary.shabnam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabnam Choudhary |
| Designation |
Professor |
| Affiliation |
Government Medical College, Jammu |
| Address |
Postgraduate Department of Pharmacology and Therapeutics, Government Medical College and Hospital, Bakshi nagar, Jammu,
Jammu and Kashmir.
JAMMU & KASHMIR
180001
India |
| Phone |
9697042817 |
| Fax |
|
| Email |
chawdhary.shabnam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Jammu, J&K, 180001
India |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Jammu |
| Address |
Government medical college, bakshi nagar, jammu, jammu and
kashmir, 180001 |
| Type of Sponsor |
Government medical college |
|
|
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 Sheena Sethi |
Government Medical College and Hospital, Jammu |
Department of
Pharmacology and
Therapeutics,
Government Medical
College and Hospital,
Jammu, Jammu and
Kashmir, 180001
Jammu
JAMMU & KASHMIR |
7006362654
drsheenasethi21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College, Jammu Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
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 |
INCLUSION CRITERIA
1. Patients of Type 2 Diabetes Mellitus attending Endocrinology OPD.
2. Patients of either sexes, aged 18 years and above.
3. Patients who are prescribed at least one anti-diabetic medication.
4. Patients willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1. Patients diagnosed with Type 1 Diabetes Mellitus.
2. Pregnant and lactating patients.
3. Patients with malignancy.
4. Patients with co-existing cause of hyperglycaemia |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OBJECTIVES
1. To study the prescribing pattern of anti-diabetic drugs in patients of
Type 2 Diabetes Mellitus.
2. To monitor the incidence and pattern of Adverse drug reactions due
to anti-diabetic drugs in patients of Type 2 Diabetes Mellitus. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OBJECTIVES
1. To study the prescribing pattern of concomitant medications given
along with anti-diabetic drugs in patients of Type 2 Diabetes Mellitus.
2. To assess the sociodemographic profile of patients with Type 2
Diabetes Mellitus |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
10/08/2024 |
| 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
|
This study will be designed to analyse the pattern of anti-diabetic drugs prescribed to the patients. Details of patient related information such as demographic profile, prescribed drug, dose, route of administration, frequency of administration will be recorded on the patient information form. Other drug related information such as number of anti-diabetic drugs per prescription, drugs prescribed by generic name vs branded name, Mono therapy vs Combination therapy, number of anti diabetic drugs prescribed from National List of Essential Medicine (latest) and details of concomitant medications will also be recorded and analyzed.
The rationality of prescriptions will be assessed using the WHO
core prescribing indicators which include :
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.
Patients on anti-diabetic drugs will also be screened for suspected Adverse Drug Reactions (ADRs). These ADRs will then be reported using Suspected Adverse Drug Reaction Reporting Form (version 1.4).
The causality assessment of the suspected ADR will be done using “WHO-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale†which categorizes causality of an ADR into 6 categories: certain, probable, possible, unlikely, conditional/unclassified,unassessable/unclassified.
Severity of the ADRs will be assessed using “Modified Hartwig and Siegel Severity Assessment scale†which categorizes severity of ADR into 7 levels (Mild= level 1 and 2, moderate= level 3 and 4, severe= 5, 6 and 7).
Preventability of ADRs will be assessed by using “Modified Schumock and Thornton scale†which categorizes the preventability of an ADR into “Definitely preventableâ€, “probably preventable†and “not preventableâ€.
Statistical Analysis of the data will be done using Microsoft Excel and SPSS software. Categorical variables will be presented as numbers and percentages and quantitative variables as mean ± SD. |