| CTRI Number |
CTRI/2025/02/081053 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study observing the drugs being prescribed to the patients with diseases of the brain in Sawai Man Singh Hospital, Jaipur. |
|
Scientific Title of Study
|
A descriptive observational study on prescribing pattern of drugs among outpatients attending department of neurology at Sawai Man Singh Hospital, Jaipur, during 2024-2026. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harsh Vardhan Bharadwaj |
| Designation |
Postgraduate Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
8262057570 |
| Fax |
|
| Email |
hvb117@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupa Kapadia |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929871911 |
| Fax |
|
| Email |
drrupakapadia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupa Kapadia |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929871911 |
| Fax |
|
| Email |
drrupakapadia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India (Pin code: 302004) |
|
|
Primary Sponsor
|
| Name |
Harsh Vardhan Bharadwaj |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India (Pin code: 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 |
| Harsh Vardhan Bharadwaj |
Sawai Man Singh Hospital |
Outpatient department, Department of Neurology, Sawai Man Singh Hospital, Jaipur, Rajasthan.
Jaipur
RAJASTHAN |
8262057570
hvb117@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed cases with Neurological disorders attending the outpatient department of Neurology.
2. Patients who are willing to participate and give written informed consent.
3. Patients aged 18 years and above of either sex. |
|
| ExclusionCriteria |
| Details |
1. Patients who are critically ill, uncooperative patients.
2. Post-surgical patients with neurological diseases/condition. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Average number of drugs per encounter (prescription).
Percentage of drugs prescribed with the generic name.
Percentage of encounters (prescription) with antibiotics prescribed.
Percentage of encounters (prescription) with injections prescribed.
Percentage of drugs prescribed from National List of Essential Medicines (NLEM 2022). |
At first encounter only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distribution of prescribed drugs according to Anatomic Therapeutic Chemical classification with their calculated Daily Defined Dose. |
At first encounter only |
| Percentage of patients with history of self medication. |
At first encounter only |
| Proportion of prescriptions with potential drug-drug interactions. |
At first encounter only |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
24/02/2025 |
| 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="1"
Months="3"
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
|
The purpose of study is to find out the current prescribing pattern of drugs in various neurological disorders by using WHO core prescribing indicators, Anatomical Therapeutic Classification and Defined Daily Dose method. The study will provide an insight into the pattern of prescription writing, drug-drug interactions (if any), self medication and possible areas of improvement in drug prescribing practices. |