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CTRI Number  CTRI/2025/03/081764 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Prevalence and risk assessment of Hypertension based on diet and physical activity among above 25 years peoples 
Scientific Title of Study   Prevalence and risk assessment of Hypertension based on Aahar Vihara approach using STEPS instrument 
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAM GOPAL TIWARI 
Designation  STUDENT 
Affiliation  Guru gorakhnath institute of medical sciences , faculty of Ayurveda 
Address  Mahayogi Gorakhnath University Gorakhpur,Arogya Dham, Balapar Road, Sonbarsa, Gorakhpur -273007, Uttar Pradesh

Gorakhpur
UTTAR PRADESH
273007
India 
Phone  7565877819  
Fax    
Email  ay01220064@mgug.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Gopikrishna S 
Designation  Professor and Head  
Affiliation  Guru gorakhnath institute of medical sciences , faculty of Ayurveda 
Address  Mahayogi Gorakhnath University Gorakhpur,Arogya Dham, Balapar Road, Sonbarsa, Gorakhpur -273007, Uttar Pradesh

Gorakhpur
UTTAR PRADESH
273007
India 
Phone  9449664358  
Fax    
Email  drgopikrishna.acharya@mgug.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr. Gopikrishna S 
Designation  Professor and Head  
Affiliation  Guru gorakhnath institute of medical sciences , faculty of Ayurveda 
Address  Mahayogi Gorakhnath University Gorakhpur,Arogya Dham, Balapar Road, Sonbarsa, Gorakhpur -273007, Uttar Pradesh

Gorakhpur
UTTAR PRADESH
273007
India 
Phone  9449664358  
Fax    
Email  drgopikrishna.acharya@mgug.ac.in  
 
Source of Monetary or Material Support  
Guru Gorakshnath Institute of Medical Sciences - Faculty of Ayurveda Aarogya Dham, Balapar Road, Sonbarsa-273007 (UP)INDIA 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  ccras spark 61-65,Institutinol Area,opp. DBlock,Janakpuri,New DELHI-110058 
Type of Sponsor  Government funding agency 
 
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 
DrGopikrishna S  Guru Gorakshnath Institute of Medical Sciences , Faculty of Ayurveda  Guru Gorakshanth Institute of Medical Sciences , Faculty of Ayurveda , Arogya Dham, Balapar road, Sonabarssa, Gorakhpur
Gorakhpur
UTTAR PRADESH 		 9449664358

drgopikrishna.acharya@mgug.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
"Institutional Ethics Committee(HumanStudies)"ofGGIMS&MDAC Of MGUG  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  aged above 25 both male and female 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Aged above 25 years (both male and female) providing written informed consent.

No history of hypertension, diabetes, cancer, and cardiovascular and/or renal diseases. 
 
ExclusionCriteria 
Details  Acute cases with compromised renal, hepatic, or cardiac function requiring in-patient department (IPD) admission for more than two weeks.

Any history of taking medication for cardiovascular disease (CVD), diabetes, renal disease, hypertension, dyslipidemia, or cancer.

Pregnant or breastfeeding women were also excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Early identification of hypertension risk factors using STEPS instrument and Aahar
Vihara questionnaire.
2. Will personalize lifestyle and dietary interventions based on Ayurvedic principles to
prevent and manage hypertension.
3. Will develop community-based programs promoting healthy Aahar and Vihara practices.
4. Will increase awareness about hypertension prevention and management through Aahar
Vihara approach.
5. Will integrate Aahar Vihara approach with conventional treatment for better hypertension
management. 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NILL  NILL 
 
Target Sample Size   Total Sample Size="342"
Sample Size from India="342" 
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)   02/03/2026 
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="3"
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,often referred to as a silent killer is a major pubilc health challenge globally. Hypertension is a major risk factor for cardiovascular diseases and a global public health challenge. In Ayurveda, We emphasize preventing and managing hypertension through balanced Aahar(diet) and Vihar(lifestyle).The STEPS instrument is a population- based survey method designed to colect data on the risk factors.The integration of ayurvedic principles with modern diagnostics and risk assessment tools could offer more holistic and individulalized approach to hypertension management.

 
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