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CTRI Number  CTRI/2018/08/015345 [Registered on: 16/08/2018] Trial Registered Prospectively
Last Modified On: 14/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To check the blood pressure of people, their knowledge and the problems that can occur because of high blood pressure in rural and urban people of udupi 
Scientific Title of Study   Prevalence, awareness and risk factors of Hypertension in rural and urban population of Udupi 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anusha Bharadwaj 
Designation  Student 
Affiliation  Welcomgroup Graduate School of administration 
Address  Welcomgroup Graduate School of administration, Department of Allied Hospitality Studies Manipal Udupi, Karnataka 576104
Welcomgroup Graduate School of administration, Department of Allied Hospitality Studies Manipal Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  8123195426  
Fax    
Email  anubaraj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Swathi Acharya K 
Designation  Asst. Professor Senior sccale 
Affiliation  Welcomgroup Graduate School of administration 
Address  Welcomgroup Graduate School of administration, Department of Allied Hospitality Studies Manipal Udupi, Karnataka 576104
Department of Allied Hospitality Studies Manipal Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9535071393  
Fax    
Email  swathi.acharya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Swathi Acharya K 
Designation  Asst. Professor Senior sccale 
Affiliation  Welcomgroup Graduate School of administration 
Address  Welcomgroup Graduate School of administration, Department of Allied Hospitality Studies Manipal Udupi, Karnataka 576104
Department of Allied Hospitality Studies Manipal Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9535071393  
Fax    
Email  swathi.acharya@manipal.edu  
 
Source of Monetary or Material Support  
Swathi Acharya K Asst. Professor M.Sc Dietetics and Nutrition Welcomgroup graduate school of administration Department of school of allied health sciences Manipal Udupi Karnataka-576104  
 
Primary Sponsor  
Name  Anusha Bharadwaj 
Address  Welcomgroup graduate school of administration Department of school of allied health sciences Manipal Udupi Karnataka-576104 
Type of Sponsor  Other [Self] 
 
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 
Anusha Bharadwaj  Anusha Bharadwaj  V P nagar, manipal saralabettu,badagabettu, heraga, malpe,kalmady, kadekar,badanidiyoor
Udupi
KARNATAKA 		 8123195426

anubaraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hypertension 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age group of 30-70 years
Rural and Urban population of Udupi
 
 
ExclusionCriteria 
Details  Pregnant and Lactating women, terminally ill patients such as AIDS,Cancer etc
Below the age of 30 years and above the age of 70 years. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
to assess the prevalencce, awareness and risk factors of hypertension in rural and urban areas of udupi  first visit 
 
Secondary Outcome  
Outcome  TimePoints 
• To assess the prevalence of hypertension in Urban and rural population of Udupi
• To assess the awareness and risk factors of hypertension in urban rural population
• To assess the relationship between the presence of hypertension with the awareness level and risk factors
 		 40 min with each person for the collection of data 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
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)   23/08/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/08/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Hypertension is the outraging problem of Indian society. Studies have reported that the prevalence of Hypertension in the urban zones of India is higher than the rural zones. Awareness level of Hypertension is better in urban areas than in rural. Awareness level is higher in population of higher educational status. 

The main purpose of the study is assessing the prevalence of the Hypertension and its determinants in the urban and rural population of Udupi. This study will explain about at what percent of people of the community are aware about the disease and about their knowledge and about what percentage of people who are doing their regular check-up. This can give a good result about the prevalence of Hypertension in the urban and rural communities of Udupi.  

 
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