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CTRI Number  CTRI/2025/07/091956 [Registered on: 29/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of neuraminidase inhibitor in patient with hypertension 
Scientific Title of Study   Efficacy of neuraminidase inhibition in hypertension with left ventricular hypertrophy  
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 Kamal Singh Ladwal 
Designation  Junior Resident 
Affiliation  PGIMER chandigarh  
Address  Research block B Department of Pharmacology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8059565704  
Fax    
Email  kamal.ladwal1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Kakkar 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  4016, Department of Pharmacology, Research Block B, Sector 12, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9868051003  
Fax    
Email  drashishkakkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Kakkar 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  4016, Department of Pharmacology, Research Block B, Sector 12, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9868051003  
Fax    
Email  drashishkakkar@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research Sector 12 Chandigarh India 160012  
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research 
Address  Sector 12 Chandigarh India 160012 
Type of Sponsor  Research institution and hospital 
 
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 Kamal Singh Ladwal  PGIMER   Department of Pharmacology 4018, Research Block B and 1029, Department of Cardiology Advanced Cardiac Centre
Chandigarh
CHANDIGARH 		 8059565704

kamal.ladwal1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee - PGI Intramural  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oseltamivir  per oral 75mg once a day for 12 weeks 
Comparator Agent  placebo   per oral once daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  18year of age or older, regardless of gender.
Diagnosed with essential hypertension for at least 1 year
Have been on stable antihypertensive medication for a minimum of 3 months before screening.
Have a diagnosis of LVH confirmed by echocardiography, with LVMI of more than or equal to 115g/m²
for males and more than equal to 95g/m² for females.
Provide written informed consent 
 
ExclusionCriteria 
Details  Women who are pregnant and lactating
Patients with valvular heart diseases (MR, AR).
Patient with inadequate echocardiographic windows.
Suboptimal automated speckle tracking across multiple myocardial segment.
Any LV regional wall motion abnormalities.
Atrial fibrillation, frequent ectopic, left bundle branch block, paced rhythm, or
atrioventricular block.
Known secondary causes of HTN.
Known chronic kidney disease, retinopathy, or cerebrovascular diseases.
Known case of congenital heart disease.
Any history of previous cardiac surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in LVGLS   At 0, 12, and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in left ventricular mass index.  12, and 24 weeks  
Changes in fractional shortening  12 and 24 weeks 
Left ventricle posterior wall diameter in systole (LVPWs)   12 and 24 weeks 
Left ventricle posterior wall diameter in diastole (LVPWd)   12 and 24 weeks 
Interventricular septal thickness systole (IVSTs)   12 and 24 weeks 
Interventricular septal thickness diastole (IVSTd)   12 and 24 weeks  
incidence of adverse events and serious adverse events  12 and 24 weeks 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   12/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

·       This is a double blinded, randomised, parallel group, placebo controlled clinical study to be conducted in the Department of Cardiology and Pharmacology, PGIMER, Chandigarh. The purpose is to assess the efficacy and safety of neuraminidase inhibitor in hypertension with left ventricular hypertrophy.


 
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