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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  
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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