| CTRI Number |
CTRI/2025/04/084417 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Analysis of Drug Prescribing Patterns for Outpatient Type 2 Diabetes at SMS Hospital, Jaipur" |
|
Scientific Title of Study
|
A Descriptive observational study of drug prescribing pattern among outpatient Type 2 Diabetes Mellitus attending the Department of General Medicine at SMS Hospital, Jaipur
|
| 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 Sunil kumar verma |
| Designation |
Postgraduate Resident |
| Affiliation |
Sawai Man Singh Medical college, Jaipur; Rajasthan, India, 302004 |
| Address |
Department of Pharmacology, SMS Medical college, Jaipur, Rajasthan, India, 302004
Department of Pharmacology, SMS Medical college, Jaipur, Rajasthan, India, 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829175515 |
| Fax |
|
| Email |
drsunilverma82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsana Bhargava |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical college, Jaipur; Rajasthan, India, 302004 |
| Address |
Department of Pharmacology, SMS Medical college, Jaipur, Rajasthan, India, 302004
Department of Pharmacology, SMS Medical college, Jaipur, Rajasthan, India, 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829506847 |
| Fax |
|
| Email |
pharmacologyd1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotsana Bhargava |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical college, Jaipur; Rajasthan, India, 302004 |
| Address |
Department of Pharmacology, SMS Medical college, Jaipur, Rajasthan, India, 302004
Department of Pharmacology, SMS Medical college, Jaipur, Rajasthan, India, 302004
RAJASTHAN
302004
India |
| Phone |
9829506847 |
| Fax |
|
| Email |
pharmacologyd1@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College and attached Hospitals, Jaipur , Rajasthan, India, 302004 |
|
|
Primary Sponsor
|
| Name |
Dr. Sunil kumar verma |
| Address |
Department of pharmacology, SMS Medical College and attached Hospitals, Jaipur , Rajasthan, India, 302004 |
| Type of Sponsor |
Other [self] |
|
|
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 Sunil kumar verma |
Sawai Man Singh Hospital |
Room no. = 4, Out-patient
Department, Department of
General medicine , Sawai Man Singh HOSPITAL, JAIPUR,
Rajasthan, India, 302004
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
09829175515
drsunilverma82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE, SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed or follow up patient cases of type 2 diabetes mellitus with or without associated co-morbidities
2. Adults more than 18 years
3. Patients willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with type 1 diabetes mellitus and gestational Diabetes
2. Complicated type 2 diabetes mellitus cases requiring admission.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Average number of drugs per encounter
2. Percentage of drugs prescribed by generic name
3. Percentage of patient medications charts with antibiotics prescribed
4. Percentage of patient medications charts with injections prescribed.
5.Percentage of drugs prescribed from Essential Drug List of Rajasthan.
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
10/04/2025 |
| 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="6"
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
|
Diabetes
is a chronic metabolic disorder characterized by high levels of glucose (sugar)
in the blood. This condition arises from either insufficient production of
insulin by the pancreas or the body’s inability to effectively use the insulin
produced.
Prevalence Rates
Global
As
of 2021, approximately 537 million adults worldwide (aged 20-79) live with
diabetes, which represents about 10.5% of the global population. This number is
projected to rise to 783 million by 2045.
India
India
has a significant diabetes burden, with around 77 million adults affected by
diabetes, making it the country with the second-highest number of diabetes
patients globally. This number is expected to increase to 134 million by 2045.
Rajasthan
Specific
data for Rajasthan indicates a high and rising prevalence of diabetes.
According to local health reports and surveys, the prevalence in Rajasthan
mirrors national trends, with urban areas particularly affected due to
lifestyle changes and increasing obesity rates.
As
of recent studies, the prevalence of diabetes in Rajasthan is reported to be
approximately 10% of the population. This is lower than the national average in
India, which stands at around 16.1%. Efforts to manage and prevent diabetes in
Rajasthan and other regions of India include initiatives under the National Programme
for Prevention and Control of Non-Communicable Diseases (NP-NCD) and the
Ayushman Bharat scheme. These initiatives focus on screening, awareness, and
treatment of diabetes through comprehensive primary health care |