| CTRI Number |
CTRI/2018/05/014247 [Registered on: 30/05/2018] Trial Registered Prospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY ON PRESCRIBING PATTERN AND OUTCOME OF ACUTE STROKE IN A TERTIARY CARE HOSPITAL |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY ON PRESCRIBING PATTERN AND OUTCOME OF ACUTE STROKE IN A TERTIARY CARE HOSPITAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GARGI DEY |
| Designation |
POST GRADUATE IN MD PHARMACOLOGY |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE |
| Address |
D/O S.N.DEY
93,FIRST FLOOR,30th CROSS,BANASHANKARI SECOND STAGE,BANGALORE
Bangalore
KARNATAKA
560070
India |
| Phone |
8376917708 |
| Fax |
|
| Email |
gargidey16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R JYOTHI |
| Designation |
PROFESSOR |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE |
| Address |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE
Bangalore
KARNATAKA
560070
India |
| Phone |
9845612562 |
| Fax |
|
| Email |
sanjyothi03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GARGI DEY |
| Designation |
POST GRADUATE IN MD PHARMACOLOGY |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE |
| Address |
D/O S.N.DEY
93,FIRST FLOOR,30th CROSS,BANASHANKARI SECOND STAGE,BANGALORE
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
gargidey16@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GARGI DEY |
| Address |
#93,30th Cross,Banashankari second stage,Bangalore -560070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| GARGI DEY |
DEPARTMENT OF PHARMACOLOGY, KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
BANASHANKARI SECOND STAGE,BANGALORE 560070
Bangalore
KARNATAKA |
8376917708
gargidey16@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KEMPEGOWDA INSTITUTE OF SCIENCES BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ACUTE STROKE (ISCHAEMIC OR HEMORRHAGIC), (1) ICD-10 Condition: G468||Other vascular syndromes of brainin cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Study subjects of either gender aged >18 years with acute stroke of vascular origin diagnosed & confirmed by radiological investigations
2.Acute stroke with or without comorbid conditions, receiving medications
3.Recuurent stroke
4.Willingness to give written informed consent |
|
| ExclusionCriteria |
| Details |
1.Old cases of stroke admitted for co-morbidities
2.Neurological deficit due to non-vascular and other causes
3.Patients with age<18 years, pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2018 |
| Date of Study Completion (India) |
26/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submitted as dissertation to RGUHS
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Stroke is the commonest cerebrovascular disease, with prevalence progressively increasing with age and elderly subjects are more prone for various stroke-related complications.Along with early diagnosis and treatment, controlling of risk factors (like hypertension,diabetes), lifestyle measures and rehabilitation is very essential to reduce the morbidity and mortality, and to improve the quality of life.There is a need for systematic studies to know the pattern of prescribing, risk factors and outcome of acute stroke therapy to generate valid data and to formulate effective guidelines for improved quality of care and therefore the present study is taken up. |