| CTRI Number |
CTRI/2024/07/071738 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study To Know The Burden of Hypertension and its Associated Factors in Patients Attending NIUM Hospital |
|
Scientific Title of Study
|
Study on Prevalence of Hypertension with Associated Risk Factors in Patient Attending NIUM Hospital |
| 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 Qureshi Rumana Khatoon Jahid Ali |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Tahaffuzi wa Samaji Tib
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore, Karnataka - 560091.
Bangalore KARNATAKA 560091 India |
| Phone |
7848968464 |
| Fax |
|
| Email |
rummanaqureshi8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Arish MK Sherwani |
| Designation |
Prof and HOD |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Tahaffuzi wa Samaji Tib
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore, Karnataka - 560091.
Bangalore KARNATAKA 560091 India |
| Phone |
9448794691 |
| Fax |
|
| Email |
Arish_sherwani@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Qureshi Rumana Khatoon Jahid Ali |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Tahaffuzi wa Samaji Tib
National Institute of Unani Medicine Kottigepalya, Magadi Main Road Bangalore Karnataka 560091
Bangalore KARNATAKA 560091 India |
| Phone |
7848968464 |
| Fax |
|
| Email |
rummanaqureshi8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Kottigepalya Magadi main road, Bangalore-560091 Karnataka, INDIA
|
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine Bangalore |
| Address |
Dept. Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore-560091, Karnataka, INDIA. |
| Type of Sponsor |
Other [National institute for researches, prevention and cure in unani system of medicine] |
|
|
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 Qureshi Rumana Khatoon Jahid Ali |
Hospital of National Institute of Unani Medicine, Bangalore. |
Department Of Tahaffuzi Wa Samaji Tib, National Institute of Unani Medicine, kottigepalya, Magadi main road, Bangalore. Bangalore KARNATAKA |
7848968464
rummanaqureshi8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of Institutional Ethics Committee (IEC) for Biomedical Research |
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 |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 18-65 years
2)Gender: All genders
3)Clinically stable patient
|
|
| ExclusionCriteria |
| Details |
1) Those persons who are not willing to participate
in the study
2) Age: Below 18 years and above 65 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study the prevalence of the hypertension among patients attending NIUM Hospital, Bengaluru |
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study the associated risk factors of hypertension patients attending NIUM Hospital, Bengaluru. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
12/08/2024 |
| 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="1" Months="0" 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
|
Hypertension is divided into primary (essential) and secondary hypertension. Primary, idiopathic, or essential (hypertension) It is classified as ‘Essential’ in which cause is generally unknown. 2. Secondary or identifiable hypertension: It is classified as secondary when some other disease process or abnormality is involved in its causation. Prominent among these are diseases of the kidney. (Chronic glomerulonephritis and chronic pyelonephritis) tumor of the adrenal gland, Congenital narrowing of the aorta, toxemia of pregnancy, or other identifiable cause.purpose: Lack of awareness is one of the major factors leading to the increased prevalence of hypertension in
India. Many people are not aware of their hypertension condition; even in some cases, the reason for
death remains elusive, as most of the time, people suffering from hypertension do not show any
visible symptoms, remain normal, and are diagnosed only after the appearance of a cardiovascular
disease or stroke. According to the global burden of disease estimate for 2015, hypertension is the
most important cause of mortality. It is estimated that 57% and 24% of stroke and coronary artery
disease-related deaths, respectively, are due to hypertension.
4 The purpose of this study is to gain
new insights regarding the occurrence of hypertension and related risk factors among adult patients
seeking care at NIUM Hospital. We focus on the outpatient population who were seeking care from
NIUM Hospital.
6 The sole objective of antihypertensive therapy is to reduce the incidence of adverse
cardiovascular events, particularly CHD, stroke, and heart failure. Therefore, there is a need to study
the prevalence and presence of Unani clinical manifestations in hypertensive people and to develop
awareness of hypertension. Keeping these facts in mind, I decided to conduct a study on the
prevalence of hypertension and its associated risk factors in patients attending NIUM Hospital
(Bengaluru). Design:
Cross sectional analytical study.
|