| CTRI Number |
CTRI/2024/11/076644 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
clinical profile of young patients who had symptoms of stroke. stroke in younger age groups. |
|
Scientific Title of Study
|
Clinical profile of young stroke patient
in tertiary care rural hospital in India |
| 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 Shivesh jha |
| Designation |
DM Scholar |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Neurosciences,
Jawaharlal Nehru Medical College And Acharaya Vinoba Bhave Rural Hospital,Sawangi,Wardha
Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
9060942684 |
| Fax |
|
| Email |
shiveshjhaaa79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshal Rathod |
| Designation |
DM Neurology |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Neurosciences,
Jawaharlal Nehru Medical College And Acharaya Vinoba Bhave Rural Hospital,Sawangi,Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9764031941 |
| Fax |
|
| Email |
harshjan80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshal Rathod |
| Designation |
DM Neurology |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Neurosciences,
Jawaharlal Nehru Medical College And Acharaya Vinoba Bhave Rural Hospital,Sawangi,Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9764031941 |
| Fax |
|
| Email |
harshjan80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya vinoba bhave rural hospital, Sawangi, Maharashtra-442001 |
|
|
Primary Sponsor
|
| Name |
Dr Shivesh Jha |
| Address |
Department of Neurosciences,
Jawaharlal Nehru Medical College And Acharaya Vinoba Bhave Rural Hospital,Sawangi,Wardha
Maharashtra- 442001 |
| 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 |
| Dr Shivesh Jha |
Acharya Vinobha Bhave Rural Hospital |
Department Of Neurosciences, Acharya Vinobha Bhave Rural Hospital,Datta Meghe Institute of Higher Education and Reasearch Centre, Swangi, Wardha- 442001
Wardha
MAHARASHTRA |
9060942684
shiveshjhaaa79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Jawaharlal Nehru Medical College,Datta Meghe Institute of higher Education and Research (DU), ,Sawangi,Wardha Maharashtra- 442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with stroke based on clinical evaluation and neuroimaging (CT/MRI)
2. Age between 18 to 45 years.
3. Admitted to AVBRH within the study period.
4. Patients or their legal guardians who provide informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with stroke onset before 18 years or after 45 years.
2. Patients unwilling to participate in the study.
3. Patients with incomplete medical records.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To describe the clinical profile of young stroke patients (aged 18-45 years) admitted to a tertiary care rural hospital in India. |
at every week for 2 months and then every 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify the risk factors associated with young stroke in the study population.
2.To evaluate the outcomes of young stroke patients, including the length of hospital stay, modified Rankin Scale (mRS) score at discharge, & in-hospital mortality.
3.To compare the clinical profiles & outcomes of ischemic & hemorrhagic strokes in young patients.
4.To analyze the use & effectiveness of acute management strategies, such as thrombolytics & surgical interventions, in young stroke patients.
5.To assess the association between various demographic & clinical variables with the severity & outcome of stroke in young patients.
|
at every week for 2 months & then every 3 months |
|
|
Target Sample Size
|
Total Sample Size="71"
Sample Size from India="71"
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)
|
20/11/2024 |
| 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="2"
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
|
To investigate the clinical profile, risk factors, and outcomes of young stroke patients in a tertiary care rural hospital in India, thereby providing insights for improving prevention and management strategies in this demographic. This study aims to fill this gap by investigating the clinical profile, risk factors, and outcomes of young stroke patients admitted to a tertiary care rural hospital in India. The findings will provide valuable insights into the epidemiology of young stroke in rural settings and inform the development of effective interventions to reduce the burden of stroke in this vulnerable population.
|