| 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
|
|
|
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
|
|
|
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. |