| CTRI Number |
CTRI/2017/06/008779 [Registered on: 07/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/05/2017 |
| 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 of drugs given in hypertension and evaluation of cardiovascular risk in hypertensive post-menopausal women |
|
Scientific Title of Study
|
A study of anti-hypertensive drug prescription patterns and scoring of cardiovascular risk in hypertensive post-menopausal women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1179-3239 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritika Singla |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Patiala |
| Address |
Dept of Pharmacology
Govt Medical College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9041821352 |
| Fax |
|
| Email |
apurba.cnmc03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Gupta |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College Patiala |
| Address |
Dept of Pharmacology
Govt Medical College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
|
| Fax |
|
| Email |
drguptaanita@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika Singla |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Patiala |
| Address |
Dept of Pharmacology
Govt Medical College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9041821352 |
| Fax |
|
| Email |
apurba.cnmc03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Medical College Patiala |
|
|
Primary Sponsor
|
| Name |
Govt Medical College Patiala |
| Address |
Rajindra Hospital
Govt Medical College Patiala
147001 Punjab |
| 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 Ritika Singla |
Dept of Cardiology |
Rajindra Hospital
Govt Medical College Patiala
Patiala
PUNJAB |
9041821352
apurba.cnmc03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria
1 Women with self reported cessation of menstruation for more than 12 consecutive months.
2 PMW with surgically induced menopause.
3 Patients with HT in stage I/ stage II.
4 Newly diagnosed and old patients of HT.
5 Hypertensive patients with or without comorbidities like diabetes, obesity, hypothyroidism.
Exclusion Criteria
1 Women with indeterminate menopausal status.
2 Patients with SBP > 210 and/or DBP > 120 mm Hg, requiring emergency care.
3 Patients with CAD at present or previous history of CAD.
4 Patients with chronic renal or hepatic disease.
|
|
| ExclusionCriteria |
| Details |
• Women with indeterminate menopausal status.
• Patients with SBP > 210 and/or DBP > 120 mm Hg, requiring emergency care.
• Patients with CAD at present or previous history of CAD.
• Patients with chronic renal or hepatic disease.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the prescription trends of anti-hypertensive drugs in PMW. |
Single observation at the time of inclusion in the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the 10 year cardiovascular risk in PMW so that high risk PMW can be identified. |
Single observation at the time of inclusion in the study |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/01/2016 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is designed to
investigate the prescribing patterns of anti- hypertensive drugs and scoring of
cardiovascular risk in hypertensive post-menopausal women (PMW) in a
tertiary care teaching hospital in Patiala. This is an observational and
cross-sectional prospective study to be conducted on the PMW attending the
Cardiology Outpatient Department of Rajindra Hospital over a period of 1 year.
All the prescriptions prescribed to PMW for hypertension will be surveyed for
one point analysis. Questionnaires, measurements and blood biochemical indices
will be collected. The cardiovascular risk for next 10 years will be calculated
for each patient using Framingham’s cardiovascular risk calculator using Body
Mass Index (BMI) as per the online equation. Data collected from survey will be
analyzed for patterns of drug use and 10 year cardiovascular risk. |