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CTRI Number  CTRI/2024/02/062377 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Intensive BP Control in Stroke Outcome : An Indian Perspective  
Scientific Title of Study   Study of Three Month Outcome in Patients with Acute Stroke based On Intensive vs Standard Blood Pressure Control In a Tertiary Care Centre 
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 Surekha Dabla  
Designation  Head of the Department  
Affiliation  Pt B D Sharma, PGIMS , Rohtak-124001 
Address  Department of Neurology, Ward-32, Lala Shamlal Building , PGIMS , Rohtak
Department of Neurology , PGIMS , Rohtak
Rohtak
HARYANA
124001
India 
Phone  9416291276  
Fax    
Email  surekhadabla@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Surekha Dabla 
Designation  Head of the Department  
Affiliation  Pt B.D. Sharma, PGIMS , Rohtak 
Address  Ward-32, Department of Neurology, Lala Shamlal Building, PGIMS , Rohtak

Rohtak
HARYANA
124001
India 
Phone  9416291276  
Fax    
Email  surekhadabla@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Angshuman Mukherjee 
Designation  Senior Resident , DrNB Super Specialty Trainee 
Affiliation  Pt. B.D. Sharma, PGIMS , Rohtak 
Address  Ward-32, Department of Neurology, Lala Shamlal Building, PGIMS , Rohtak

Rohtak
HARYANA
124001
India 
Phone  9903885510  
Fax    
Email  angshumanmukherjee93@gmail.com  
 
Source of Monetary or Material Support  
Pt. B. D. Sharma, PGIMS , ROHTAK 124001 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak 
Address  Pt. B. D. Sharma PGIMS Rohtak- 124001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surekha Dabla  Pt B D Sharma PGIMS Rohtak 124001  Lala Shamlal Building, Ward 32 , Department of Neurology, PGIMS , Rohtak 124001
Rohtak
HARYANA 		 9416291276

surekhadabla@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt B D Sharma PGIMS/UHS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Three Month Outcome in Patients with Acute Stroke on Intensive Blood Pressure Control  Maintaining Systolic Blood Pressure between 110-120 mm Hg and Diastolic Blood Pressure between 75-80 mm Hg  
Comparator Agent  Three Month Outcome in Patients with Acute Stroke on Standard Blood Pressure Control   Maintaining Systolic Blood Pressure between 120-140 mm Hg and Diastolic Blood Pressure between 80-90 mm Hg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Hypertensive patients (Known or newly detected) with acute stroke, both hemorrhagic
and ischemic 
 
ExclusionCriteria 
Details  1. Patients with traumatic brain injury
2. Presence of hemorrhagic complications during endovascular therapy
3. Severe or fatal comorbidities that would confound the outcome of the study (e.g.
Malignancy that would affect mortality of the patients enrolled )
4. A pre-existing stroke disability defined by a modified Rankin Scale (mRS) score
greater than two 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Incidence of recurrent stroke
2.Functional outcomes (measured by MRS scale) after 3 months
3. All Cause and CVA related Mortality
 		 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. Extent of control of Hypertensive Status by various anti hypertensive regimens
3. Compliance to anti-hypertensive therapy  		 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2024 
Date of Study Completion (India) 10/02/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Hypertension is an important risk factor in the pathogenesis of both Ischemic and Hemorrhagic strokes . Thus the control of blood pressure becomes an important strategy in the prevention of stroke related co-morbidities. Our study aimed to find the impact of Intensive versus Standard BP Control on the functional status of post stroke patients measured by the mRS scale after 3 months of the index event . This was prospective comparative study where each patient was followed up for 3 months with regular OPD visits and telephonically .

 

There was statistically significant difference between the mean SBP and mean DBP at baseline and at 1st , 2nd and 3rd month follow-up in both the Intensive and Standard BP Control Groups in the respective intra-group analysis. Inter-Group analysis  between the two groups revealed that there was no statistically significant difference in the mean SBP and DBP at baseline but on follow-up there was statistically significant difference between the mean SBP and mean DBP on all 3 follow up visits .

 

The mean mRS of both the groups at baseline was 3.44 . The mean mRS of the Intensive versus the Standard BP Control Group at 3rd month follow up were 2.32 and 3.28 respectively with high statistical significance (p-value = 0.001) . There were no events of recurrent CVA during the three month follow up . Intensive BP Control was associated with improved mRS scores on three month follow up .


 
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