| CTRI Number |
CTRI/2024/07/070862 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To determine the symptoms and causes of patients presented with fever with disorientation |
|
Scientific Title of Study
|
Assessment of the clinical spectrum and outcome of acute febrile encephalopathy |
| 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 Ritik katiyar |
| Designation |
Doctor(post graduate resident) |
| Affiliation |
Maulana Azad medical college |
| Address |
1st Floor, Department of Medicine, BL Taneja Block, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi 110002, India
New Delhi
DELHI
110002
India |
| Phone |
9821670872 |
| Fax |
|
| Email |
medicine.ritik2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Anuradha |
| Designation |
Director professor |
| Affiliation |
Maulana Azad medical college |
| Address |
1st Floor, Department of Medicine, BL Taneja Block, Maulana Azad Medical College and Lok Nayak hospital, New Delhi 110002 , India.
New Delhi
DELHI
110002
India |
| Phone |
9643136268 |
| Fax |
|
| Email |
drsanuradha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Anuradha |
| Designation |
Director professor |
| Affiliation |
Maulana Azad medical college |
| Address |
1st Floor, Department of Medicine, BL Taneja Block, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi 110002 , India
New Delhi
DELHI
110002
India |
| Phone |
9643136268 |
| Fax |
|
| Email |
drsanuradha@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1st Floor, Department Of Medicine, BL Taneja Block, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi 110002 , India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
Department of Medicine, BL Taneja Block, Maulana Azad Medical College and Lok Nayak hospital, New Delhi 110002 , India |
| 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 Ritik katiyar |
Maulana Azad medical College and lok nayak hospital |
Ward 29, 3rd floor, Department of Medicine, New Medical Block, Lok Nayak Hospital, Delhi 110002
New Delhi
DELHI |
9821670872
medicine.ritik2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical College and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G934||Other and unspecified encephalopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed as acute febrile encephalopathy. |
|
| ExclusionCriteria |
| Details |
Patients in whom persistent altered mental state could be attributed only to one or more deranged metabolic parameters such as hypoglycaemia, hyperglycemia, hypercarbia, hyponatremia,hypernatremia, azotaemia, cerebrovascular accidents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study clinical spectrum and clinical outcome of patients presenting with acute febrile encephalopathy |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study aetiology of acute febrile encephalopathy |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2024 |
| 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
|
Our study is aimed at knowing the various etiologies of Acute Febrile Encephalopathy and their incidence with the help of various biochemical and radiological tests and knowing the outcome of patient condition at time of discharge and at one month after discharge using modified Rankin Scale. |