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CTRI Number  CTRI/2026/02/103384 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Use of Multiple Medicines in Patients With High Blood Pressure 
Scientific Title of Study   To Study The Prevalence Of Polypharmacy Among Patients With Hypertension At 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 ANIL KUMAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Baba Raghav Das Medical College Gorakhpur 
Address  3rd floor Department Of Pharmacology B R D medical college Gorakhpur Uttar Pradesh
Head of department residency B R D medical college campus Gorakhpur Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273013
India 
Phone  8303060884  
Fax    
Email  dranilk194@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aniruddha Sinha 
Designation  Junior Resident 
Affiliation  Baba Raghav Das Medical College Gorakhpur 
Address  3rd Floor Department Of Pharmacology B R D medical college Gorakhpur Uttar Pradesh
New PG boys Hostel B R D medical college Campus Gorakhpur Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273013
India 
Phone  9155977216  
Fax    
Email  rishu0722@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aniruddha Sinha 
Designation  Junior Resident 
Affiliation  Baba Raghav Das Medical College Gorakhpur 
Address  3rd Floor Department Of Pharmacology B R D medical college Gorakhpur Uttar Pradesh
New PG boys hostel B R D medical college campus Gorakhpur Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273013
India 
Phone  9155977216  
Fax    
Email  rishu0722@gmail.com  
 
Source of Monetary or Material Support  
Department Of Pharmacology B R D medical college Gorakhpur , Uttar Pradesh Uttar Pradesh pin code 273013 INDIA 
 
Primary Sponsor  
Name  Aniruddha Sinha 
Address  3rd Floor Department Of Pharmacology B R D medical college Gorakhpur Uttar Pradesh 273013 India 
Type of Sponsor  Other [self] 
 
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 
Aniruddha Sinha  Baba Raghav Das Medical College  3rd Floor Department Of Pharmacology B R D medical college Gorakhpur Uttar Pradesh
Gorakhpur
UTTAR PRADESH 
9155977216

rishu0722@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee Baba Raghav Das Medical College Gorakhpur  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  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults of either gender.
Age should be more than 30 years and above.
Individuals having systolic blood pressure of 140-179mmHg and diastolic blood pressure of 90-109mmHg.
Hypertensive patients.
Hypertensive patients with co morbid conditions such as diabetes mellitus etc. 
 
ExclusionCriteria 
Details  Patients who did not give informed consent.
Patients less than 18 years and more than 80 years old.
Patients with severe illness such as chronic kidney disease, malignancy. etc.
Pregnant and lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of polypharmacy among hypertensive patients, defined as the proportion of patients receiving five or more concurrent prescribed medications at a tertiary care center.  At the time of outpatient department baseline than every 1 week till study 
 
Secondary Outcome  
Outcome  TimePoints 
Appropriateness of polypharmacy among hypertensive patients, categorized as appropriate or inappropriate based on standard clinical guidelines  At the time of outpatient department baseline than every 1 week till study 
 
Target Sample Size   Total Sample Size="241"
Sample Size from India="241" 
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)   05/03/2026 
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="0"
Months="6"
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  
This study aims to assess the prevalence of polypharmacy among patients with hypertension attending a tertiary care center. Polypharmacy is defined as the concurrent use of five or more prescribed medications. Hypertension is a common chronic condition that often coexists with other diseases such as diabetes mellitus and cardiovascular disorders leading to the use of multiple drugs. The increasing burden of polypharmacy is associated with adverse drug reactions drug  drug interactions medication nonadherence and increased healthcare costs.

This is a prospective observational cross sectional study conducted in the Department of Pharmacology in collaboration with the Department of Medicine at a tertiary care hospital. Adult patients aged thirty years and above diagnosed with hypertension and attending the outpatient department during the study period will be included after obtaining informed consent. Demographic details clinical parameters comorbid conditions and complete medication profiles will be recorded using a structured proforma.

The primary outcome of the study is to determine the prevalence of polypharmacy among hypertensive patients. Secondary outcomes include assessment of appropriateness of polypharmacy evaluation of factors associated with polypharmacy analysis of antihypertensive prescribing patterns and identification of potential drug drug interactions and adverse drug reactions. Data will be analyzed using descriptive statistical methods. The findings of this study are expected to provide insight into prescribing practices and help promote rational use of medicines among hypertensive patients.
 
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