| CTRI Number |
CTRI/2025/05/087721 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usage of Multiple drugs in hypertensive patients. |
|
Scientific Title of Study
|
To Study The Prevalence Of Polypharmacy Among Patients With Hypertension At Tertiary Care Hospital In North India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AJINK VASUDEV PAWAR |
| Designation |
Junior resident |
| Affiliation |
Government medical college and rajindra hospital |
| Address |
Department of pharmacology, Government medical college Patiala, Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab.
Patiala
PUNJAB
147001
India |
| Phone |
08928736224 |
| Fax |
|
| Email |
vasudevpawarajink@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjleen kaur |
| Designation |
Associate professor |
| Affiliation |
Government medical college and rajindra hospital |
| Address |
Department of pharmacology, Government medical college Patiala,Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab.
Patiala Subdistrict
Patiala
PUNJAB
147001
India |
| Phone |
9855210999 |
| Fax |
|
| Email |
anjleen9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjleen kaur |
| Designation |
Associate professor |
| Affiliation |
Government medical college and rajindra hospital |
| Address |
Department of pharmacology, Government medical college Patiala,Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab.
Patiala Subdistrict
Patiala
PUNJAB
147001
India |
| Phone |
9855210999 |
| Fax |
|
| Email |
anjleen9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajindra Hospital , Patiala
Department of pharmacology Government medical College Patiala , Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab, 147001, India. |
|
|
Primary Sponsor
|
| Name |
Department of pharmacology Government medical college,Patiala |
| Address |
Government medical College Patiala,Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Patiala, Punjab 147001, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ajink Vasudev pawar |
Rajindra Hospital |
Room no 1A, unit -2, outpatient department of medicine.
Patiala
PUNJAB
Patiala
PUNJAB |
08928736224
vasudevpawarajink@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Government medical college , Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals having systolic blood pressure of 140-179mmHg and diastolic blood pressure of 90-109mmHg.
2. Hypertensive patients.
3. Hypertensive patients with co morbid conditions such as diabetes mellitus etc.
|
|
| ExclusionCriteria |
| Details |
1. Patients who did not give informed consent.
2. Patients less than 18 years and more than 80 years old.
3. Patients with severe illness such as chronic kidney disease, malignancy. etc.
4. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of Polypharmacy Among hypertensive patients attending out patient department of medicine. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
10/06/2025 |
| 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="0"
Months="3"
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
|
Polypharmacy is associated with drug–drug or food–drug interactions that may pose treatment difficulties. The effects of polypharmacy are numerous and should concern physicians and policy makers both in terms of finances (due to significant health costs) and medical consequences (due to multiple drug interactions).The aim of this study is to evaluate the prevalence of polypharmacy among hypertensive patients at tertiary care hospital in North India.
|