CTRI Number |
CTRI/2018/05/014045 [Registered on: 22/05/2018] Trial Registered Retrospectively |
Last Modified On: |
18/05/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
A study to evaluate drugs used in patients of Hypertension and relation of development of Cardiovascular diseases and Quality of Life in patients of Hypertension |
Scientific Title of Study
|
A study to evaluate Prescribing Pattern and correlation between Cardiovascular risk and Quality of life in patients of Hypertension |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1188-7585 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Faiziul Haq |
Designation |
Junior Resident |
Affiliation |
Govt. Medical College, Rajindra Hospital, Patiala-147001 Punjab (India) |
Address |
Department of Pharmacology,
Govt. Medical College, Rajindra Hospital,
Patiala-147001 Punjab (India)
Patiala PUNJAB 147001 India |
Phone |
9453249946 |
Fax |
|
Email |
drfaiziulhaqrmu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anjleen Kaur |
Designation |
Assistant professor |
Affiliation |
GOVT. MEDICAL COLLEGE, RAJINDRA HOSPITAL, PATIALA-147001 PUNJAB (INDIA) |
Address |
DEPARTMENT OF PHARMACOLOGY
GOVT. MEDICAL COLLEGE, RAJINDRA HOSPITAL,
PATIALA-147001 PUNJAB (INDIA)
Patiala PUNJAB 147001 India |
Phone |
9855210999 |
Fax |
|
Email |
anjleen9@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Faiziul Haq |
Designation |
junior resident |
Affiliation |
GOVT. MEDICAL COLLEGE, RAJINDRA HOSPITAL, PATIALA-147001 PUNJAB (INDIA) |
Address |
DEPARTMENT OF PHARMACOLOGY
GOVT. MEDICAL COLLEGE, RAJINDRA HOSPITAL,
PATIALA-147001 PUNJAB (INDIA)
Patiala PUNJAB 147001 India |
Phone |
9023249946 |
Fax |
|
Email |
drfaiziulhaqrmu@gmail.com |
|
Source of Monetary or Material Support
|
Govt. Medical College, Rajindra Hospital,
Patiala-147001 Punjab (India) |
|
Primary Sponsor
|
Name |
Govt Medical College Rajindra Hospital Patiala |
Address |
Govt. Medical College, Rajindra Hospital,
Patiala-147001 Punjab (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 |
Dr Faiziul Haq |
Govt. Medical College, Rajindra Hospital, Patiala |
Room no. 1, Department of Medicine, Rajindra hospital Patiala, -147001 Punjab (India) Patiala PUNJAB |
9453249946
drfaiziulhaqrmu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
RESEARCH AND ETHICAL COMMITTEE GOVT. MEDICAL COLLEGE, PATIALA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Hypertension, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients with hypertension in stage I/stage II.
2. Newly diagnosed and old patients of hypertension.
3. Hypertensive patients with or without comorbidities.
|
|
ExclusionCriteria |
Details |
1. Patients with SBP > 210 and/or DBP > 120 mm Hg, requiring emergency care.
2. Patients with CAD at present or previous history of CAD.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. To evaluate the prescribing pattern of anti-hypertensive drugs in patients of hypertension.
2. To evaluate the 10 year cardio-vascular risk in patients of hypertension.
|
one year |
|
Secondary Outcome
|
Outcome |
TimePoints |
3. To establish correlation between Cardiovascular risk and Health related quality of life in patients of hypertension. |
one year |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
14/02/2017 |
Date of Study Completion (India) |
06/02/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
No publication yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Introduction: Hypertension is a chronic disease characterized by high blood pressure. Prolonged uncontrolled hypertension is implicated in various cardiovascular diseases like myocardial infarction, stroke, etc. Moreover, the disease can deteriorate the quality of life of patients as well.
Aim of the study: The aims of the study are to evaluate prescribing pattern and correlation between Cardiovascular risk and Quality of Life in patients of Hypertension.
Material and methods: In this observational cross-sectional study ,patients of known hypertension attending the Medicine OPD, Government Medical College and Rajindra Hospital, Patiala will be recruited for a period of one year. The required information will be noted. The patients fulfilling the inclusion criteria and after verifying the exclusion criteria will be included in this study. All the prescriptions will be analyzed for the pattern of the medication prescribed. The cardiovascular risk score will be calculated according to the Framingham General CVD Risk Prediction scale using BMI. The health-related quality of life will be calculated using the Medical outcome survey- Short Form 36. The patients will be asked the questions in a layman language and the form will be filled accordingly by the investigator.
Clinical significance: There is scarcity of studies which establish the correlation between cardiovascular risk and health-related quality of life in Indian population. This study may help in formulating management guidelines based on twin guiding principles of cardiovascular risk score and health-related quality of life.
Keywords: Hypertension, Prescribing pattern, Cardiovascular risk score, Health-related Quality of Life, Medical outcome survey- Short Form 36. |