| CTRI Number |
CTRI/2025/07/090161 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Forward-Looking Study on the Symptoms, Causes, Treatment, and Recovery of Stroke patients in our hospital |
|
Scientific Title of Study
|
A prospective observational study on clinical profiles, risk factors, management and outcomes of stroke patients in a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Abdul Jaleel Kirmani |
| Designation |
Consultant Neurosurgeoon |
| Affiliation |
Glenfield Malla Reddy Brain Heart Hospital |
| Address |
Room no. 1, department of neurosurgery, first floor, Glenfield Malla Reddy Brain Heart Hospital, 5-9-91, Chapel road, Nampally, Hyderabad- 500001
Hyderabad
TELANGANA
500001
India |
| Phone |
6301123442 |
| Fax |
|
| Email |
dr.abduljaleel@gmbhhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Abdul Jaleel Kirmani |
| Designation |
Consultant Neurosurgeoon |
| Affiliation |
Glenfield Malla Reddy Brain Heart Hospital |
| Address |
Room no.1, department of neurosurgery, first floor, Glenfield Malla Reddy Brain Heart Hospital, 5-9-91, Chapel Road, Nampally, Hyderabad- 500001
Hyderabad
TELANGANA
500001
India |
| Phone |
6301123442 |
| Fax |
|
| Email |
dr.abduljaleel@gmbhhospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Abdul Jaleel Kirmani |
| Designation |
Consultant Neurosurgeoon |
| Affiliation |
Glenfield Malla Reddy Brain Heart Hospital |
| Address |
Room no.1, Department of neurosurgery, First floor, Glenfield Malla Reddy Brain Heart Hospital, 5-9-91, Chapel Road, Nampally, Hyderabad -500001
Hyderabad
TELANGANA
500001
India |
| Phone |
6301123442 |
| Fax |
|
| Email |
dr.abduljaleel@gmbhhospital.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Glenfield Malla Reddy Brain Heart Hospital |
| Address |
5-9-91, Chapel Road, Nampally, Hyderabad-500001 |
| Type of Sponsor |
Other [No Funding needed as the trial is investigator initiated.] |
|
|
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 Syed Abdul Jaleel Kirmani |
Glenfield malla reddy brain heart hospital |
Room no.1, Department of neurosurgery, first floor, Glenfield Malla Reddy Brain Heart Hospital, 5-9-91, chapel road, nampally, hyderabad
Hyderabad
TELANGANA |
6301123442
dr.abduljaleel@gmbhhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MALLA REDDY MEDICAL COLLEGE FOR WOMEN INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60-I69||Cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as stroke (WHO and AHA guidelines).
2. Patients aged 18 years or older at the time of diagnosis.
3. Patients admitted in our hospital within 7 days of symptom onset. |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of traumatic brain injury leading to intracranial hemorrhage.
2. Pregnant or lactating women.
3. Patients who decline participation.
4. Patients with any other neurological disorders mimicking stroke. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcomes of stroke management in patients after 6 months post stroke |
At baseline, following up for a week, 1 month, 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality & quality of life of stroke patients after 6 months post stroke |
At baseline, 1 month, 3 month, & 6 month |
|
|
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)
|
10/08/2025 |
| 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
|
The aim of our study is to investigate the clinical profiles, risk factors, management strategies and outcomes of stroke patients admitted to a tertiary care hospital through a prospective observational approach. Our objectives are to assess the clinical profiles and sub-types of stroke among patients admitted at our hospital and to evaluate the management strategies employed, including acute treatments, surgical interventions secondary prevention measures and rehabilitation protocols. |