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CTRI Number  CTRI/2026/03/106475 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Health effects of some medicines used to control high blood pressure or fast heart rate 
Scientific Title of Study   Behavioral changes and extra-pyramidal symptoms in elderly patients on L-type calcium channel blockers. 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sankha Shubhra Chakrabarti 
Designation  Professor 
Affiliation  Institute of Medical Sciences Banaras Hindu University 
Address  Department of Geriatric Medicine Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8874452095  
Fax    
Email  sankha.chakrabarti1@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Sankha Shubhra Chakrabarti 
Designation  Professor 
Affiliation  Institute of Medical Sciences Banaras Hindu University 
Address  Department of Geriatric Medicine Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8874452095  
Fax    
Email  sankha.chakrabarti1@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Sankha Shubhra Chakrabarti 
Designation  Professor 
Affiliation  Institute of Medical Sciences Banaras Hindu University 
Address  Department of Geriatric Medicine Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8874452095  
Fax    
Email  sankha.chakrabarti1@bhu.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  BANARAS HINDU UNIVERSITY 
Address  BANARAS HINDU UNIVERSITY VARANASI-221005 UTTAR PRADESH 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Sankha Shubhra Chakrabarti  Sir Sunderlal Hospital   Department of Geriatric Medicine Room number 113 Ground floor
Varanasi
UTTAR PRADESH 		 8874452095

sankha.chakrabarti1@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Medical Sciences BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10-I16||Hypertensive diseases, (2) ICD-10 Condition: I49||Other cardiac arrhythmias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcium channel blockers  Any one out of Amlodipine 2.5 mg to 10 mg Cilnidipine 10 mg to 20 mg Nifedipine 10 mg to 60 mg (All doses- based on clinical judgement; oral; continued as long as indicated as per prevalent guidelines for blood pressure control or till adverse event warrants cessation of therapy) 
Intervention  Calcium channel blockers  Diltiazem 30 mg to 360 mg or Verapamil 40 mg to 360 mg (All doses- based on clinical judgement; oral; continued as long as indicated as per prevalent guidelines for heart rate control or till adverse event warrants cessation of therapy) 
Comparator Agent  Other medicines for hypertension  Any one or more out of Telmisartan 20 mg to 80 mg Olmesartan 20 mg to 40 mg Chlorthalidone or Hydrochlorothiazide 6.25 mg to 25 mg Metoprolol 12.5 mg to 200 mg or equivalent other beta blockers Prazosin 2.5 mg to 10 mg Ramipril 1.25 mg to 10 mg Clonidine 0.1 mg to 0.6 mg or equivalent other central alpha blocker (All doses- based on clinical judgement; oral; continued as long as indicated as per prevalent guidelines for blood pressure control or till adverse event warrants cessation of therapy) 
Comparator Agent  Other medicines for tachyarrhythmias or tachycardia  Metoprolol 12.5 mg to 100 mg or equivalent beta-blockers or Digoxin 0.125 mg or Ivabradine 5 mg to 10 mg (All doses- based on clinical judgement; oral; continued as long as indicated as per prevalent guidelines for heart rate control or till adverse event warrants cessation of therapy) 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Elderly patients who are more than/equal to 60 years of age and diagnosed with hypertension or tachycardia/tachyarrhythmia and
started on CCBs or other anti hypertensives or started on CCBs or other rate controlling agents and who give consent to participate in the study
 
 
ExclusionCriteria 
Details  Patients with below mentioned conditions shall be excluded
Associated dementia
Established neuropsychiatric disorders at baseline
Serious illnesses like myocardial infarction or stroke which may deem recruitment in study unfavorable as per treating geriatrician
Serious acute illness requiring hospitalization
Significant hearing or speech or vision loss which makes communication impossible
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Behavioral changes   at baseline 1 month 3 month 6 month and 12 month 
 
Secondary Outcome  
Outcome  TimePoints 
Motor disorders   at baseline 1 month 3 month 6 month and 12 month 
Quality of life   at baseline 1 month 3 month 6 month and 12 month 
Cognitive status  at baseline 1 month 3 month 6 month and 12 month 
Depression status  at baseline 1 month 3 month 6 month and 12 month 
Functional status  at baseline 1 month 3 month 6 month and 12 month 
Adverse events  at baseline 1 month 3 month 6 month and 12 month 
Motion sensor data- exploratory  at baseline 1 month 3 month 6 month and 12 month- optional 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   30/03/2026 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The proposed study aims to evaluate the impact of calcium channel blockers and other drugs on elderly patients with a primary focus on identifying the incidence of behavioral changes while secondary objectives include assessing motor disorders determining epidemiologic risk factors and comparing outcomes such as quality of life adverse events and cognitive performance. Elderly patients aged 60 years and above from the Geriatric OPD or ward diagnosed with hypertension or tachycardia and started on calcium channel blockers or other antihypertensives or rate controlling agents including those previously diagnosed but untreated for at least one month will be recruited and followed for one year. Subgroup analyses between those on CCBs alone and those on CCBs combined with others will be performed. Exclusion criteria include dementia HMSE less than 25 established neuropsychiatric disorders serious illnesses such as myocardial infarction or stroke acute conditions requiring hospitalization and significant hearing speech or vision loss. Participants will be categorized into four groups based on drug class and condition. Outcomes will be assessed at baseline 1 month 3 month 6 month and 12 month respectively.

 
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