| CTRI Number |
CTRI/2017/08/009364 [Registered on: 14/08/2017] Trial Registered Prospectively |
| Last Modified On: |
11/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Does tablet Nebivolol improve disability in Stroke patients? |
|
Scientific Title of Study
|
Neuroprotective Efficay of Nebivolol Vs Amlodipine in patients with ischemic stroke-A pilot randomized controlled clinical trial |
| Trial Acronym |
NEON |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin Karuppan |
| Designation |
Consultant General Medicine |
| Affiliation |
Hindu Mission Hospital |
| Address |
Department of General Medicine
Hindu Mission Hospital
103 GST Road Tambaram
Chennai
Chennai
TAMIL NADU
600 045
India |
| Phone |
9884551515 |
| Fax |
|
| Email |
drashwinkaruppan83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Karuppan |
| Designation |
Consultant General Medicine |
| Affiliation |
Hindu Mission Hospital |
| Address |
Department of General Medicine
Hindu Mission Hospital
103 GST Road Tambaram
Chennai
Chennai
TAMIL NADU
600 045
India |
| Phone |
9884551515 |
| Fax |
|
| Email |
hmhcrd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Melvin George |
| Designation |
Consultant Clinical Research |
| Affiliation |
Hindu Mission Hospital |
| Address |
Hindu Mission Hospital
103 GST Road Tambaram
Chennai
Chennai
TAMIL NADU
600 045
India |
| Phone |
9894133697 |
| Fax |
|
| Email |
melvingeorge2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hindu Mission Hospital
No 103 GST Road West tambaram, Chennai 600045 |
|
|
Primary Sponsor
|
| Name |
HINDU MISSION HOSPITAL |
| Address |
NO 103 GST ROAD
WEST TAMBARAM,
CHENNAI-600045 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Deparment of clinical reserach |
NO 103 GST ROAD
WEST TAMBARAM,
CHENNAI-600045 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAshwin Karuppan |
Hindu Mission Hospital |
Room No 10 , Ground Floor Sri Rama Nama block
Hindu Mission Hospital
Chennai
TAMIL NADU |
9884551515
drashwin83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hindu Mission Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
age 18 to 75 yrs of both gender.
Onset of stroke symptoms (ischemic) within 6 to 36 hours prior to beginning of treatment.
NIHSS score more than 5. SBP more than 140 mmHg or DBP more than 90 mmHg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amlodipine |
Amlodipine 5mg once daily for ten days |
| Intervention |
Nebivolol |
Nebivolol 5mg once daily for ten days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Onset of stroke symptoms ischemic within 6 to 36 hours prior to beginning of treatment.
NIHSS score greater or equal to 5.
Known case of hypertension or SBP more than 140 mmHg or DBP more than 90 mmHg.
|
|
| ExclusionCriteria |
| Details |
Haemorrhagic Stroke, other Central Nervous System (CNS) diseases, including brain tumor, demyelinating diseases, inflammatory diseases, a history of craniotomy or severe brain injuries and idiopathic intracranial hypertension.
Any known contra-indication to Nebivolol such as severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome, (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B).
Acute or chronic renal failure.
Pre-existing infectious disease requiring other antibiotic therapy.
Pregnant Women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is to compare National Institute of Health Stroke Scale (NIHSS) score modified Barthel Index (mBI) and modified Rankin Scale (mRS) score at admission and on days 30 and 90
|
baseline 10 days 30 days and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Events Monitoring |
baseline 10 days 30 days and 90 days |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/08/2017 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Stroke is one of the leading causes of disability worldwide. Currently the only drug available for the treatment of stroke is alteplase. However the disadvantage of the drug is that patients are eligible to be given this drug only if they present to the hospital within 4.5 hrs of onset of stroke symptoms. Physiotherapy remains the only option left to improve disability in these patients. So there is a definite need to identify novel drugs for preventing disability due to stroke. Nebivolol is a third-generation beta blocker, that has been used in the treatment of hypertension for the past 15 years. Besides reducing the blood pressure, Nebivolol also has the property of reducing oxidative stress and improving endothelial dysfunction. So the study is being done to see if nebivolol when given for a period of 7-10 days in acute ischemic stroke could improve the disability related to stroke. |