| CTRI Number |
CTRI/2022/08/044608 [Registered on: 03/08/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out corelation of serum ferritin level in Acute Hemorrhagic and non Hemorrhagic stroke |
|
Scientific Title of Study
|
Study Of Corelation Of Serum Ferritin Level In Acute Haemorrhagic and Non Haemorrhagic Stroke And Its Prognosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Buddhadeb Majumder |
| Designation |
PG Scholar |
| Affiliation |
SCHOOL OF MEDICINE , Dr. D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
Department of General Medicine , School Of Medicine , Dr. DY Patil Hospital and Deemed to be University , Nerul , Navi Mumbai , Thane , Maharashtra , pin - 400706 , India
Thane
MAHARASHTRA
400706
India |
| Phone |
8794640058 |
| Fax |
|
| Email |
i.am.dr.buddha.deb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Buddhadeb Majumder |
| Designation |
PG Scholar |
| Affiliation |
SCHOOL OF MEDICINE , Dr. D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
Department of General Medicine , School Of Medicine , Dr. DY Patil Hospital and Deemed to be University , Nerul , Navi Mumbai , Thane , Maharashtra , pin - 400706 , India
Thane
MAHARASHTRA
400706
India |
| Phone |
8794640058 |
| Fax |
|
| Email |
i.am.dr.buddha.deb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nivedita Moulick |
| Designation |
Professor |
| Affiliation |
SCHOOL OF MEDICINE , Dr. D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
Department of General Medicine , School Of Medicine , Dr. DY Patil Hospital and Deemed to be University , Nerul , Navi Mumbai , Thane , Maharashtra , pin - 400706 , India
Thane
MAHARASHTRA
400706
India |
| Phone |
9833022282 |
| Fax |
|
| Email |
ndmoulick@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| SCHOOL OF MEDICINE, Dr D Y PATIL DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
Dr Buddhadeb Majumder |
| Address |
Department of General Medicine, School Of Medicine, Dr. D Y Patil Hospital and Deemed to be University , sector 5 , Nerul , Navi Mumbai |
| 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 Buddhadeb Majumder |
SCHOOL OF MEDICINE , Dr. D Y PATIL DEEMED TO BE UNIVERSITY |
Department Of General Medicine , School Of Medicine , Dr DY Patil Hospital and Deemed To Be University , Sector 5 , Nerul , Navi Mumbai , Thane , Maharashtra
Thane
MAHARASHTRA |
8794640058
i.am.dr.buddha.deb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of Acute Hemorrhagic And Non Hemorrhagic Stroke would be taken as study participants.
2. Diagnosis of stroke confirmed on CT-Scan/MRI Brain.
3. Patients present within 48 hours of symptoms onset.
|
|
| ExclusionCriteria |
| Details |
1. Patient not fulfilling the inclusion criteria
2. Old case of Hemorrhagic And Non Hemorrhagic Stroke
3. Patients with Diselectrolytemia
4. Patients of Hypoglycemia
5. Known Case of Seizure disorder
6. Known Case of Haemochromatosis
7. Patient with Secondary Iron Overload Condition (H/O Blood transfusion and Hemolysis)
8. Known Case of IDA or Anemia of Chronic disease
9. Patient with associated infection and inflammation
10. Patient with H/O malignancy
11. Known case of Hepatocellular Carcinoma
12. Known case of still’s disease
13. Known case of Goucher’s disease
14. Known case of Hyperthyroidism
15. Patients of Dengue
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Find out the Correlation of Serum Ferritin Level In Acute Haemorrhagic and Non Haemorrhagic Stroke And its Prognosis |
data collected on first day of presentation and day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the outcome of Acute Hemorrhagic And Non Hemorrhagic Stroke |
data collected on first day of presentation and day 7 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/08/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is the clinical observational study for completion under Dr. D Y Patil deemed to be University
Total duration of trial is 1 year
Title : Study Of Corelation Of Serum Ferritin Level In Acute Haemorrhagic and Non Haemorrhagic Stroke And Its Prognosis
Study Group : Sample Size 100
Study Centre : School Of Medicine , Dr. DY Patil deemed to be University and Hospital, Nerul , Navi Mumbai
PG Scholar : Dr. Buddhadeb Majumder
Guide : Dr. Nivedita Moulick
|