| CTRI Number |
CTRI/2022/10/046115 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
15/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Number of hypertension cases among adults visiting a government community health centre |
|
Scientific Title of Study
|
Prevalence of hypertension among adults visiting a Government community health centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAkshaya Sekar |
| Designation |
Postgraduate |
| Affiliation |
Kasturba medical college/ Manipal academy of higher education |
| Address |
3rd floor,
Department of Community Medicine
Kasturba Medical college
Manipal
Udupi district
Karnataka- 576104
3rd floor,
Department of Community Medicine
Kasturba Medical college
Manipal
Udupi district
Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9787568460 |
| Fax |
|
| Email |
akshayasekar03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kini |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical college/ Manipal academy of higher education |
| Address |
3rd floor,
Department of Community Medicine
Kasturba Medical college
Manipal
Udupi district
Karnataka- 576104
3rd floor,
Department of Community Medicine
Kasturba Medical college
Manipal
Udupi district
Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844616750 |
| Fax |
|
| Email |
sanjay.kb@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrAkshaya Sekar |
| Designation |
Postgraduate |
| Affiliation |
Kasturba medical college/ Manipal academy of higher education |
| Address |
3rd floor,
Department of Community Medicine
Kasturba Medical college
Manipal
Udupi district
Karnataka- 576104
3rd floor,
Department of Community Medicine
Kasturba Medical college
Manipal
Udupi district
Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9787568460 |
| Fax |
|
| Email |
akshayasekar03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal academy of higher education, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Manipal
Udupi district
Karnataka- 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Community health centre |
Byndoor, Kundapura taluk, Udupi district |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akshaya Sekar |
Community health centre, Byndoor |
Byndoor, Kundapura taluk, Uudpi district, Karnataka
Udupi
KARNATAKA |
9787568460
akshayasekar03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital |
Approved |
| NOC letter from CHC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With and without hypertension |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 19 years are included in the study |
|
| ExclusionCriteria |
| Details |
Subjects not willing to participate in the study
RTA and MLC cases |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of hypertension in population attending a government byndor will be assessed. |
4 weeks and 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between hypertension and socio demographic factors/substance use/BMI will be assesed |
1 month |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
10/10/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypertension is an iceberg disease. Hypertension is the single largest contributor to the avoidable deaths and diseases in India. India is facing a huge challenge of increasing burden of NCDs because of rapid epidemiological transition. Most of the rural areas data on prevalence of prehypertension and hypertension is lacking. Lack of data may lead to underestimation of this important health problem in rural areas. As very few studies have been conducted in rural areas of Karnataka of Southern India, hence this study was undertaken to estimate the prevalence and risk factors of pre hypertension and hypertension in rural area of Karnataka of Southern India. |