| CTRI Number |
CTRI/2022/05/042767 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
23/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the knowledge on dietary management of hypertension in young adult men |
|
Scientific Title of Study
|
Exploring The Knowledge On Dietary
Management Of Hypertension In Young Adult Men Aged Between 24-30 years
living in Mumbai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ilyas Qureshi |
| Designation |
Student |
| Affiliation |
Dr BMN college of home science |
| Address |
AZAD FARID CHAWL, ROHIDAS WADA, NEAR LAL SETH CHAWL, KALYAN WEST
338 R A Kidwai Road Matunga Mumbai
Thane
MAHARASHTRA
Ms Ilyas Qureshi
India |
| Phone |
-7900173575 |
| Fax |
|
| Email |
qureshiniyaz258@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha Chopra |
| Designation |
Professor |
| Affiliation |
Dr BMN college of home science |
| Address |
338 R A Kidwai road
Matunga Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
-9969810104 |
| Fax |
|
| Email |
harshachopra@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Ilyas Qureshi |
| Designation |
Student |
| Affiliation |
Dr BMN college of home science |
| Address |
AZAD FARID CHAWL, ROHIDAS WADA, NEAR LAL SETH CHAWL, KALYAN WEST
338 R A Kidwai Road Matunga Mumbai
Thane
MAHARASHTRA
Ms Ilyas Qureshi
India |
| Phone |
-7900173575 |
| Fax |
|
| Email |
qureshiniyaz258@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR BMN COLLEGE OF HOME SCIENCE |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [self sponsored ] |
|
|
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 |
| Ms Ilyas Qureshi |
Al-Riyaz Health Care Center |
Najma palace shop number 6 Rafi Ahmed Kidwai Road opp Bhoiwada kalyan west
Thane
MAHARASHTRA |
-7900173575
qureshiniyaz258@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AL-RIYAZ HEALTH CARE CENTER |
Not Applicable |
| SEVA MANDAL EDUCATION SOCIETY’S INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
1. Young adult men living in Mumbai.
2. They should be between 24-30 years
3. Free from known illness or disease specially hypertension
|
|
| ExclusionCriteria |
| Details |
1. Should not suffer from the Medical and Nutrition field.
2. They should not be suffering from any known disease or hypertension condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will provide insights of the knowledge about hypertension in young men and also help in understanding the level of knowledge and accuracy that can be effective
Also with the help of data obtained and understating of their nutrition knowledge gaps can be identified and interventions can be planned |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/05/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypertension (HTN) is one of the major risk factors for the majority of cardiovascular morbidity and mortality. Blood pressure is the pressure that is exerted by circulating blood against the walls of the body’s arteries, the major blood vessels in the body. It refers to the pressure measured within large arteries in the systemic circulation [WHO, Hypertension, 2021]. This value is divided into two parts: systolic and diastolic blood pressure. Blood pressure is traditionally measured using a sphygmomanometer. It is measured in millimeters of mercury and expressed in terms of the systolic pressure over diastolic pressure [Foëx & Sear, 2004]. |