| CTRI Number |
CTRI/2025/12/098961 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective observational study to evaluate the etiology and clinical profile of adult patients with new onset seizures. |
|
Scientific Title of Study
|
To study the clinical profile and evaluate the diagnostic yeild of various investigations in adults presenting with new onset seizures |
| 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 Saurabh Patil |
| Designation |
Junior resident |
| Affiliation |
Dr. D. Y. Patil Medical College, Navi Mumbai |
| Address |
Department of general medicine, Dr. D. Y. Patil medical college, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
7719914495 |
| Fax |
|
| Email |
saurabhpatil0123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Pendse |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical College, Navi Mumbai |
| Address |
Department of general medicine, Dr. D. Y. Patil medical college, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9320051082 |
| Fax |
|
| Email |
drmanishpendse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Patil |
| Designation |
Junior resident |
| Affiliation |
Dr. D. Y. Patil Medical College, Navi Mumbai |
| Address |
Department of general medicine, Dr. D. Y. Patil medical college, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
7719914495 |
| Fax |
|
| Email |
saurabhpatil0123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra, India, 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Saurabh Patil |
| Address |
Department of General medicine, Dr D Y Patil medical college and Hospital, Nerul, Navi mumbai , Thane , Maharashtra 400706 |
| Type of Sponsor |
Other [(primary Investigator)] |
|
|
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 Saurabh Patil |
Dr D Y Patil Hospital , Navi Mumbai |
OPD-1 (General Medicine), OPD 16 (Neurology) , Male medicine ward, Female medicine ward, Intensive care Unit ,Dr D Y Patil Hospital , Navi Mumbai
Thane
MAHARASHTRA |
7719914495
saurabhpatil0123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical and health research IECBH of Dr DY Patil medical College Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years and above
Patients presenting with their first ever seizure or first presentation to medical attention for seizures
Patients who have experienced a seizure within the past 4 weeks prior to presentation |
|
| ExclusionCriteria |
| Details |
Patients with known history of epilepsy or seizure disorder
Patients with a history of febrile seizures in childhood
Patients with psychogenic non epileptic seizures as the final diagnosis
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the demographic characteristics clinical presentation and etiologically spectrum of new onset seizures in adults. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the diagnostic yield of various investigations including neuroimaging, electroencephalography (EEG), and laboratory tests in identifying the underlying causes of new-onset seizures. |
1year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/12/2025 |
| 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="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
|
Aims and objectives
To study the clinical profile and evaluate the diagnostic yield of various investigations in adults presenting with new onset seizures |