| CTRI Number |
CTRI/2024/11/076278 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see effectivity and safety of anti seizure drugs in primary and secondary prevention of seizure in patients of Acute Encephalitis Syndrome. |
|
Scientific Title of Study
|
Effectiveness and Safety of use of Antiseizure medications for the primary and secondary prophylaxis of seizures in Acute Encephalitis Syndrome in tertiary care hospital centre – 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 Riya |
| Designation |
Post Graduate- Junior Resident |
| Affiliation |
AIIMS, Raipur |
| Address |
2nd floor, 2211, Department of Pharmacology ,medical college, Aiims , Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
08003076502 |
| Fax |
|
| Email |
riyayadav21042000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Yogendra narayanrao keche |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
2204, Department of Pharmacology,2nd floor, medical college, Aiims , Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8818882119 |
| Fax |
|
| Email |
drynkeche@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya |
| Designation |
Post Graduate- Junior Resident |
| Affiliation |
AIIMS, Raipur |
| Address |
2211,2nd floor, Department of Pharmacology, medical college, Aiims , Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
08003076502 |
| Fax |
|
| Email |
riyayadav21042000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences, Raipur |
| Address |
All india institute of medical sciences, raipur, chattisgarh [492099] |
| 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 Riya |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Department of Pharmacology, Medical College Building.
Raipur
CHHATTISGARH |
8003076502
riyayadav21042000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS , RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G040||Acute disseminated encephalitis and encephalomyelitis (ADEM), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 14 years
Definite, probable or confirmed case of acute encephalitis syndrome as per WHO guidelines
Patients prescribed antiseizure medications |
|
| ExclusionCriteria |
| Details |
Already taking ASM
known case of epilepsy
Undergone neurosurgical intervention
With other presdisposing diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patient having no clinical seizure till time of discharge after initiation of treatment.
|
every week till the time of discharge and at the end of 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients having improvement in EEG at the end of 3 months after initiation of treatment as compared to baseline. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
15/11/2024 |
| 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="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
|
Encephalitis is an acute inflammation of brain parenchyma and/or meninges, associated with
neurological dysfunction. The cause can be both infectious and non-infectious. Of the
infectious causes, Viral Encephalitis is the most common cause. Seizures are the very common presentation of encephalitis . Currently there are no guidelines for use of antiseizure medications in these patients. Our study aims to find out whether these medication results in prevention of further seizures in encephalitis patients. |